<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="3324271">
  <adverse_event_report>
    <yyqq>99Q3</yyqq>
    <isr>3319393</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>3319393-1</image>
    <event_date>1999-04-14</event_date>
    <manufacturer_date>1999-07-26</manufacturer_date>
    <fda_date>1999-08-05</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>1999-07-1117</manufacturer_number>
    <manufacturer_sending>Schering-Plough Corporation</manufacturer_sending>
    <age>10.0</age>
    <age_units>YR</age_units>
    <gender>F</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="HO"/>
    <reaction reaction_preferred_term="Anxiety Nec"/>
    <reaction reaction_preferred_term="Arthralgia"/>
    <reaction reaction_preferred_term="Back Pain"/>
    <reaction reaction_preferred_term="Bronchospasm Nos"/>
    <reaction reaction_preferred_term="Difficulty In Walking"/>
    <reaction reaction_preferred_term="Feeling Abnormal"/>
    <reaction reaction_preferred_term="Hyperventilation"/>
    <reaction reaction_preferred_term="Hypoaesthesia"/>
    <reaction reaction_preferred_term="Nausea"/>
    <reaction reaction_preferred_term="Nervousness"/>
    <report_source report_source_code="FGN"/>
    <report_source report_source_code="HP"/>
    <report_source report_source_code="OTH"/>
    <drug_datum>
      <drug_sequence>1001194462</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>Theo-Dur</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></nda_number>
      <therapy>
        <start_date>1999-04-14</start_date>
        <end_date>1999-04-14</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001219138</drug_sequence>
      <role_code>SS</role_code>
      <drug_name>Foradil</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>RESPIRATORY (INHALATION)</administration_route>
      <dechallenge_code>Y</dechallenge_code>
      <rechallenge_code>D</rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>1999-04-14</start_date>
        <end_date>1999-04-14</end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1001219140</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Meptin</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>1001219141</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Alevaire</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>1001219142</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Aminophylline</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>1001219143</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Ambroxol Hydrochloride</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>1001219145</drug_sequence>
      <role_code>C</role_code>
      <drug_name>Theophylline</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>
