<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="4086314">
  <adverse_event_report>
    <yyqq>04Q1</yyqq>
    <isr>4284807</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>4284807-X</image>
    <event_date>2004-01-23</event_date>
    <manufacturer_date></manufacturer_date>
    <fda_date>2004-02-02</fda_date>
    <report_code>DIR</report_code>
    <manufacturer_number></manufacturer_number>
    <manufacturer_sending></manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>F</gender>
    <is_electronic_submission>false</is_electronic_submission>
    <weight>56.699</weight>
    <weight_units>KG</weight_units>
    <report_date>2004-01-31</report_date>
    <reporter_occupation>CN</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified>false</manufacturer_notified>
    <confidentiality_status>false</confidentiality_status>
    <reporter_country></reporter_country>
    <outcome outcome_code="DS"/>
    <reaction reaction_preferred_term="ANOSMIA"/>
    <reaction reaction_preferred_term="BURNING SENSATION"/>
    <reaction reaction_preferred_term="HYPOGEUSIA"/>
    <drug_datum>
      <drug_sequence>1004584428</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>ZICAM</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route>NASAL</administration_route>
      <dechallenge_code>D</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>2004-01-23</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
