<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3005450">
  <adverse_event_report>
    <yyqq>97Q4</yyqq>
    <isr>3002975</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3002975-4</image>
    <event_date>1997-01-01</event_date>
    <manufacturer_date>1997-11-13</manufacturer_date>
    <fda_date>1997-11-26</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>001-0981-972601</manufacturer_number>
    <manufacturer_sending>Parke-Davis Pharm. Research, Div W-L Co.</manufacturer_sending>
    <age>57.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="Back Pain"/>
    <reaction reaction_preferred_term="Dermatitis Nos"/>
    <reaction reaction_preferred_term="Eye Haemorrhage Nec"/>
    <reaction reaction_preferred_term="Iritis"/>
    <reaction reaction_preferred_term="Nonhodgkin'S Lymphoma Nos"/>
    <reaction reaction_preferred_term="Tinnitus"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1000009174</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Lipitor</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1997-01-01</start_date>
        <end_date>1997-11-13</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000015811</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Cardizem</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>1000015812</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ecotrin</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>1000015813</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Indocin</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>1000015814</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Zyloprim</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_report>
    <yyqq>98Q1</yyqq>
    <isr>3099744</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>2</followup_sequence>
    <image>3099744-6</image>
    <event_date>1997-04-01</event_date>
    <manufacturer_date>1998-06-15</manufacturer_date>
    <fda_date>1998-03-26</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>001-0981-972601</manufacturer_number>
    <manufacturer_sending>Parke-Davis Pharm. Research</manufacturer_sending>
    <age>57.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <reaction reaction_preferred_term="Back Pain"/>
    <reaction reaction_preferred_term="Dermatitis Nos"/>
    <reaction reaction_preferred_term="Diabetes Mellitus Nos"/>
    <reaction reaction_preferred_term="Eye Haemorrhage Nec"/>
    <reaction reaction_preferred_term="Iritis"/>
    <reaction reaction_preferred_term="Nonhodgkin'S Lymphoma Nos"/>
    <reaction reaction_preferred_term="Tinnitus"/>
    <report_source report_source_code="HP"/>
    <drug_datum>
      <drug_sequence>1000214406</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Lipitor</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1997-02-01</start_date>
        <end_date>1997-11-01</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
      <therapy>
        <start_date>1998-03-30</start_date>
        <end_date>1998-04-06</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000529604</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Cardizem</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>1000529605</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ecotrin</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>1000529606</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Indocin</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>1000529615</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Zyloprim</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_report>
    <yyqq>98Q2</yyqq>
    <isr>3066907</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence>1</followup_sequence>
    <image>3066907-5</image>
    <event_date>1997-04-01</event_date>
    <manufacturer_date>1998-04-13</manufacturer_date>
    <fda_date>1998-04-23</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>001-0981-972601</manufacturer_number>
    <manufacturer_sending>Parke-Davis Pharm. Research, Div W-L Co.</manufacturer_sending>
    <age>57.0</age>
    <age_units>YR</age_units>
    <gender>M</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date></report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <reaction reaction_preferred_term="Back Pain"/>
    <reaction reaction_preferred_term="Dermatitis Nos"/>
    <reaction reaction_preferred_term="Eye Haemorrhage Nec"/>
    <reaction reaction_preferred_term="Iritis"/>
    <reaction reaction_preferred_term="Tinnitus"/>
    <report_source report_source_code="CSM"/>
    <drug_datum>
      <drug_sequence>1000131047</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Lipitor</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code>N</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1997-02-01</start_date>
        <end_date>1997-11-01</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1000152663</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Cardizem</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>1000152664</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ecotrin</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>1000152665</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Indocin</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>1000152666</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Zyloprim</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>
