<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6140287">
  <adverse_event_report>
    <yyqq>06Q3</yyqq>
    <isr>5113034</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5113034-9</image>
    <event_date>2006-01-01</event_date>
    <manufacturer_date>2006-09-07</manufacturer_date>
    <fda_date>2006-09-20</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006109907</manufacturer_number>
    <manufacturer_sending>PFIZER INC</manufacturer_sending>
    <age>39.0</age>
    <age_units>YR</age_units>
    <gender>F</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>50.8023</weight>
    <weight_units>KG</weight_units>
    <report_date>2006-09-19</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="HO"/>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="HEADACHE"/>
    <reaction reaction_preferred_term="HEART RATE IRREGULAR"/>
    <reaction reaction_preferred_term="NIGHTMARE"/>
    <reaction reaction_preferred_term="PANIC ATTACK"/>
    <reaction reaction_preferred_term="PULMONARY THROMBOSIS"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1007697334</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code>N</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>2006-08-01</start_date>
        <end_date>2006-09-03</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007723285</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PLAVIX</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>1007723286</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_datum>
    <drug_datum>
      <drug_sequence>1007723287</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PANTOPRAZOLE SODIUM</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>1007723295</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>1007723296</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PROPRANOLOL</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>1007723297</drug_sequence>
      <role_code>C</role_code>
      <drug_name>SYNTHROID</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>1007723298</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>
    <drug_datum>
      <drug_sequence>1007723299</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FLOVENT</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>1007723300</drug_sequence>
      <role_code>C</role_code>
      <drug_name>METOPROLOL (METOPROLOL)</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_report>
    <yyqq>06Q4</yyqq>
    <isr>5149978</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5149978-1</image>
    <event_date>2006-08-01</event_date>
    <manufacturer_date>2006-10-26</manufacturer_date>
    <fda_date>2006-11-08</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>2006109907</manufacturer_number>
    <manufacturer_sending>PFIZER INC</manufacturer_sending>
    <age>39.0</age>
    <age_units>YR</age_units>
    <gender>F</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>50.8023</weight>
    <weight_units>KG</weight_units>
    <report_date>2006-11-07</report_date>
    <reporter_occupation>MD</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="HO"/>
    <outcome outcome_code="OT"/>
    <outcome outcome_code="RI"/>
    <reaction reaction_preferred_term="HEADACHE"/>
    <reaction reaction_preferred_term="HEART RATE IRREGULAR"/>
    <reaction reaction_preferred_term="NIGHTMARE"/>
    <reaction reaction_preferred_term="PANIC REACTION"/>
    <reaction reaction_preferred_term="PULMONARY THROMBOSIS"/>
    <report_source report_source_code="CSM"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1007847794</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>CHANTIX</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</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="SMOKING CESSATION THERAPY
"/>
      <therapy>
        <start_date>2006-08-01</start_date>
        <end_date>2006-09-03</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007876520</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PLAVIX</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>1007876521</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_datum>
    <drug_datum>
      <drug_sequence>1007876522</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PANTOPRAZOLE SODIUM</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>1007876524</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>1007876525</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PROPRANOLOL</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>1007876526</drug_sequence>
      <role_code>C</role_code>
      <drug_name>SYNTHROID</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>1007876527</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>
    <drug_datum>
      <drug_sequence>1007876528</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FLOVENT</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>1007876529</drug_sequence>
      <role_code>C</role_code>
      <drug_name>METOPROLOL TARTRATE</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>
