<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6117395">
  <adverse_event_report>
    <yyqq>06Q3</yyqq>
    <isr>5085632</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5085632-2</image>
    <event_date>2006-01-01</event_date>
    <manufacturer_date>2006-08-03</manufacturer_date>
    <fda_date>2006-08-17</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006097483</manufacturer_number>
    <manufacturer_sending>PFIZER INC.</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>F</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2006-08-15</report_date>
    <reporter_occupation></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="CONSTIPATION"/>
    <reaction reaction_preferred_term="FLATULENCE"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1007600488</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>CHANTIX                               (VARENICLINE)</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>D</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="SMOKING CESSATION THERAPY
"/>
      <therapy>
        <start_date>2006-07-14</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007620665</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>IBUPROFEN</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="FIBROMYALGIA
"/>
      <drug_indication indication_preferred_term="SWELLING
"/>
      <therapy>
        <start_date>2006-01-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007620686</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>PROVIGIL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="NARCOLEPSY
"/>
      <therapy>
        <start_date>2006-07-05</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007620694</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>NORCO</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="NECK PAIN
"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007620695</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ALL OTHER THERAPEUTIC PRODUCTS</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>1007620696</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CORRECTOL                                    (INOSINE MONOPHOSPHATE DI</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>
  </adverse_event_report>
</adverse_event_case>
