<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6623340">
  <adverse_event_report>
    <yyqq>08Q2</yyqq>
    <isr>5716489</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5716489-1</image>
    <event_date>2006-04-09</event_date>
    <manufacturer_date>2008-04-14</manufacturer_date>
    <fda_date>2008-04-24</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-wye-h03628708</manufacturer_number>
    <manufacturer_sending>wyeth pharmaceuticals inc.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>111.23</weight>
    <weight_units>KG</weight_units>
    <report_date>2008-04-24</report_date>
    <reporter_occupation>cn</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="aggression"/>
    <reaction reaction_preferred_term="agitation"/>
    <reaction reaction_preferred_term="anger"/>
    <reaction reaction_preferred_term="condition aggravated"/>
    <reaction reaction_preferred_term="depression"/>
    <reaction reaction_preferred_term="drug effect decreased"/>
    <reaction reaction_preferred_term="drug withdrawal syndrome"/>
    <reaction reaction_preferred_term="irritability"/>
    <reaction reaction_preferred_term="logorrhoea"/>
    <reaction reaction_preferred_term="mania"/>
    <reaction reaction_preferred_term="mood altered"/>
    <reaction reaction_preferred_term="morbid thoughts"/>
    <reaction reaction_preferred_term="panic disorder"/>
    <reaction reaction_preferred_term="restlessness"/>
    <reaction reaction_preferred_term="schizoaffective disorder"/>
    <reaction reaction_preferred_term="suicidal ideation"/>
    <reaction reaction_preferred_term="thinking abnormal"/>
    <drug_datum>
      <drug_sequence>1009830029</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>effexor xr</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020699</nda_number>
      <drug_indication indication_preferred_term="MAJOR DEPRESSION"/>
      <therapy>
        <start_date>2001-01-01</start_date>
        <end_date>2008-04-07</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830030</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>effexor xr</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>020699</nda_number>
      <therapy>
        <start_date>2008-04-10</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830031</drug_sequence>
      <role_code>c</role_code>
      <drug_name>soma</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="MUSCLE RELAXANT THERAPY"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830032</drug_sequence>
      <role_code>c</role_code>
      <drug_name>risperdal</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_datum>
    <drug_datum>
      <drug_sequence>1009830033</drug_sequence>
      <role_code>c</role_code>
      <drug_name>hydrocodone bitartrate</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="PAIN"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830034</drug_sequence>
      <role_code>c</role_code>
      <drug_name>inderal</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_datum>
    <drug_datum>
      <drug_sequence>1009830035</drug_sequence>
      <role_code>c</role_code>
      <drug_name>neurontin</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_datum>
    <drug_datum>
      <drug_sequence>1009830036</drug_sequence>
      <role_code>c</role_code>
      <drug_name>oxycodone hcl</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="PAIN"/>
      <therapy>
        <start_date>2008-04-08</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830037</drug_sequence>
      <role_code>ss</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></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="MAJOR DEPRESSION"/>
      <therapy>
        <start_date>2008-04-08</start_date>
        <end_date>2008-04-09</end_date>
        <duration>2.0</duration>
        <duration_units>day</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009830038</drug_sequence>
      <role_code>c</role_code>
      <drug_name>diazepam</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_datum>
  </adverse_event_report>
</adverse_event_case>
