<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7079390">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6297843</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6297843-9</image>
    <event_date>2009-04-27</event_date>
    <manufacturer_date></manufacturer_date>
    <fda_date>2009-08-04</fda_date>
    <report_code>dir</report_code>
    <manufacturer_number></manufacturer_number>
    <manufacturer_sending></manufacturer_sending>
    <age>44.0</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>58.967</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-08-03</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>true</confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="mania"/>
    <reaction reaction_preferred_term="suicidal ideation"/>
    <drug_datum>
      <drug_sequence>1012003471</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>pristiq</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>y</dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="depression"/>
      <therapy>
        <start_date>2009-03-29</start_date>
        <end_date>2009-04-29</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
