<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6210641">
  <adverse_event_report>
    <yyqq>06Q4</yyqq>
    <isr>5192447</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5192447-3</image>
    <event_date>2006-01-01</event_date>
    <manufacturer_date>2006-12-09</manufacturer_date>
    <fda_date>2006-12-20</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006151748</manufacturer_number>
    <manufacturer_sending>PFIZER INC</manufacturer_sending>
    <age>36.0</age>
    <age_units>YR</age_units>
    <gender>F</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>56.699</weight>
    <weight_units>KG</weight_units>
    <report_date>2006-12-19</report_date>
    <reporter_occupation>CN</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="OT"/>
    <reaction reaction_preferred_term="ANXIETY"/>
    <reaction reaction_preferred_term="CRYING"/>
    <reaction reaction_preferred_term="DISEASE RECURRENCE"/>
    <reaction reaction_preferred_term="FEELING ABNORMAL"/>
    <reaction reaction_preferred_term="FOOD CRAVING"/>
    <reaction reaction_preferred_term="LOSS OF EMPLOYMENT"/>
    <reaction reaction_preferred_term="NAUSEA"/>
    <reaction reaction_preferred_term="NERVOUSNESS"/>
    <reaction reaction_preferred_term="PARANOIA"/>
    <reaction reaction_preferred_term="POLLAKIURIA"/>
    <reaction reaction_preferred_term="STRESS"/>
    <reaction reaction_preferred_term="THINKING ABNORMAL"/>
    <reaction reaction_preferred_term="URINARY INCONTINENCE"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1007987063</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>XANAX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>U</dechallenge_code>
      <rechallenge_code>U</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>18276</nda_number>
      <drug_indication indication_preferred_term="PANIC ATTACK
"/>
      <therapy>
        <start_date>2006-11-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1008021373</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>U</dechallenge_code>
      <rechallenge_code>U</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="EX-SMOKER
"/>
      <therapy>
        <start_date>2006-11-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1008021375</drug_sequence>
      <role_code>C</role_code>
      <drug_name>VITAMIN B COMPLEX CAP</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>
