<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6191711">
  <adverse_event_report>
    <yyqq>06Q4</yyqq>
    <isr>5179078</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5179078-6</image>
    <event_date></event_date>
    <manufacturer_date>2006-12-08</manufacturer_date>
    <fda_date>2006-12-19</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>US-JNJFOC-20061202588</manufacturer_number>
    <manufacturer_sending>JOHNSON + JOHNSON PHARMACEUTICAL R+D</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>F</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2006-12-19</report_date>
    <reporter_occupation>LW</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country>UNITED STATES</reporter_country>
    <outcome outcome_code="DE"/>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="DEATH"/>
    <drug_datum>
      <drug_sequence>1007954350</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>RISPERDAL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>UNKNOWN</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="DRUG USE FOR UNKNOWN INDICATION
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007954351</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>SEROQUEL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="DRUG USE FOR UNKNOWN INDICATION
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007954352</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>ZYPREXA</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="DRUG USE FOR UNKNOWN INDICATION
"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>07Q4</yyqq>
    <isr>5501801</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5501801-9</image>
    <event_date></event_date>
    <manufacturer_date>2007-10-25</manufacturer_date>
    <fda_date>2007-10-30</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-jnjfoc-20061202588</manufacturer_number>
    <manufacturer_sending>johnson + johnson pharmaceutical r+d</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2007-10-30</report_date>
    <reporter_occupation>lw</reporter_occupation>
    <death_date>2005-11-02</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="death"/>
    <drug_datum>
      <drug_sequence>1009100896</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="schizophrenia, paranoid type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009100897</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="delusional disorder, unspecified type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009100898</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009100899</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>zyprexa</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>07Q4</yyqq>
    <isr>5562658</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5562658-3</image>
    <event_date></event_date>
    <manufacturer_date>2007-12-06</manufacturer_date>
    <fda_date>2007-12-17</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-jnjfoc-20061202588</manufacturer_number>
    <manufacturer_sending>johnson + johnson pharmaceutical r+d</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2007-12-17</report_date>
    <reporter_occupation>lw</reporter_occupation>
    <death_date>2005-11-02</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="cerebrovascular accident"/>
    <reaction reaction_preferred_term="diabetes mellitus"/>
    <drug_datum>
      <drug_sequence>1009295996</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="schizophrenia, paranoid type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009295997</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="delusional disorder, unspecified type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009295998</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009295999</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>zyprexa</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q2</yyqq>
    <isr>6151078</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6151078-9</image>
    <event_date></event_date>
    <manufacturer_date>2009-04-01</manufacturer_date>
    <fda_date>2009-04-10</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-jnjfoc-20061202588</manufacturer_number>
    <manufacturer_sending>ortho-mcneil-janssen pharmaceuticals, inc.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-04-10</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date>2005-11-02</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="cerebrovascular accident"/>
    <reaction reaction_preferred_term="diabetes mellitus"/>
    <drug_datum>
      <drug_sequence>1011408794</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="schizophrenia, paranoid type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011408795</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="delusional disorder, unspecified type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011408796</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011408797</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>zyprexa</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6317497</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6317497-2</image>
    <event_date>2005-11-01</event_date>
    <manufacturer_date>2009-08-14</manufacturer_date>
    <fda_date>2009-08-21</fda_date>
    <report_code>per</report_code>
    <manufacturer_number>us-jnjfoc-20061202588</manufacturer_number>
    <manufacturer_sending>ortho-mcneil-janssen pharmaceuticals, inc.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-08-21</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date>2005-11-02</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="cerebrovascular accident"/>
    <reaction reaction_preferred_term="diabetes mellitus"/>
    <drug_datum>
      <drug_sequence>1012082512</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="delusional disorder, unspecified type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012082513</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012082514</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>zyprexa</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6369563</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6369563-3</image>
    <event_date>2005-11-01</event_date>
    <manufacturer_date>2009-08-14</manufacturer_date>
    <fda_date>2009-09-23</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-jnjfoc-20061202588</manufacturer_number>
    <manufacturer_sending>ortho-mcneil-janssen pharmaceuticals, inc.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-09-23</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date>2005-11-02</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="cerebrovascular accident"/>
    <reaction reaction_preferred_term="diabetes mellitus"/>
    <drug_datum>
      <drug_sequence>1012296893</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>risperdal</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>unknown</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020272</nda_number>
      <drug_indication indication_preferred_term="delusional disorder, unspecified type"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012296894</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012296895</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>zyprexa</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="drug use for unknown indication"/>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
