<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6674840">
  <adverse_event_report>
    <yyqq>08Q2</yyqq>
    <isr>5781408</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5781408-9</image>
    <event_date>2008-06-11</event_date>
    <manufacturer_date>2008-06-12</manufacturer_date>
    <fda_date>2008-06-23</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-wye-h04460408</manufacturer_number>
    <manufacturer_sending>wyeth pharmaceuticals inc.</manufacturer_sending>
    <age>62.0</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2008-06-23</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="HO"/>
    <reaction reaction_preferred_term="EAR HAEMORRHAGE"/>
    <reaction reaction_preferred_term="LOSS OF CONSCIOUSNESS"/>
    <drug_datum>
      <drug_sequence>1010071310</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>pristiq</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>c87436</lot_number>
      <expiration_date></expiration_date>
      <nda_number>021992</nda_number>
      <drug_indication indication_preferred_term="MAJOR DEPRESSION"/>
      <therapy>
        <start_date>2008-06-11</start_date>
        <end_date>2008-06-12</end_date>
        <duration>2.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
