<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6199523">
  <adverse_event_report>
    <yyqq>06Q4</yyqq>
    <isr>5168628</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5168628-1</image>
    <event_date>2006-10-01</event_date>
    <manufacturer_date>2006-11-20</manufacturer_date>
    <fda_date>2006-12-01</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006144194</manufacturer_number>
    <manufacturer_sending>PFIZER INC</manufacturer_sending>
    <age>58.0</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>2006-11-30</report_date>
    <reporter_occupation>OT</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="AGGRESSION"/>
    <reaction reaction_preferred_term="ALCOHOL USE"/>
    <reaction reaction_preferred_term="BLOOD ALCOHOL INCREASED"/>
    <reaction reaction_preferred_term="DRUG INEFFECTIVE"/>
    <reaction reaction_preferred_term="FALL"/>
    <reaction reaction_preferred_term="LOSS OF CONSCIOUSNESS"/>
    <reaction reaction_preferred_term="NAUSEA"/>
    <reaction reaction_preferred_term="SLEEP DISORDER"/>
    <reaction reaction_preferred_term="SOMNOLENCE"/>
    <reaction reaction_preferred_term="TREATMENT NONCOMPLIANCE"/>
    <report_source report_source_code="CSM"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1007924182</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>21928</nda_number>
      <drug_indication indication_preferred_term="EX-SMOKER
"/>
      <therapy>
        <start_date>2006-10-22</start_date>
        <end_date>2006-11-01</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007970198</drug_sequence>
      <role_code>C</role_code>
      <drug_name>LAMICTAL</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>1007970200</drug_sequence>
      <role_code>C</role_code>
      <drug_name>DESYREL</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>1007970201</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ZOLOFT</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>1007970202</drug_sequence>
      <role_code>C</role_code>
      <drug_name>BELLADONNA ALKALOIDS (BELLADONNA ALKALOIDS)</drug_name>
      <validated_or_verbatim>2</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>1007970203</drug_sequence>
      <role_code>C</role_code>
      <drug_name>LIBRAX</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>1007970204</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FOLIC ACID</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>1007970205</drug_sequence>
      <role_code>C</role_code>
      <drug_name>LESCOL</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>1007970206</drug_sequence>
      <role_code>C</role_code>
      <drug_name>KLONOPIN</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>
