<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6115253">
  <adverse_event_report>
    <yyqq>06Q3</yyqq>
    <isr>5082391</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5082391-4</image>
    <event_date>2006-07-01</event_date>
    <manufacturer_date>2006-07-31</manufacturer_date>
    <fda_date>2006-08-14</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006094798</manufacturer_number>
    <manufacturer_sending>PFIZER INC</manufacturer_sending>
    <age>78.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>79.3786</weight>
    <weight_units>KG</weight_units>
    <report_date>2006-08-11</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="CONDITION AGGRAVATED"/>
    <reaction reaction_preferred_term="DECREASED APPETITE"/>
    <reaction reaction_preferred_term="WHEEZING"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1007586950</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>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>2006-07-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007611323</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ARAVA</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>1007611324</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PACERONE</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>1007611325</drug_sequence>
      <role_code>C</role_code>
      <drug_name>TOPROL-XL</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>1007611326</drug_sequence>
      <role_code>C</role_code>
      <drug_name>LIPITOR</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>1007611327</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FUROSEMIDE</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>1007611328</drug_sequence>
      <role_code>C</role_code>
      <drug_name>LOTREL</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>1007611329</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ACETYLSALICYLIC ACID SRT</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>1007611330</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ALLOPURINOL</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>1007611331</drug_sequence>
      <role_code>C</role_code>
      <drug_name>IRON</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>1007611332</drug_sequence>
      <role_code>C</role_code>
      <drug_name>COMBIVENT</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>1007611333</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CLONIDINE</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>1007611334</drug_sequence>
      <role_code>C</role_code>
      <drug_name>SPIRIVA</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>
