<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6158796">
  <adverse_event_report>
    <yyqq>06Q4</yyqq>
    <isr>5140279</isr>
    <initial_followup_code>I</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5140279-4</image>
    <event_date>2006-02-01</event_date>
    <manufacturer_date>2006-10-27</manufacturer_date>
    <fda_date>2006-10-31</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>US-GLAXOSMITHKLINE-A0625184A</manufacturer_number>
    <manufacturer_sending>GLAXOSMITHKLINE</manufacturer_sending>
    <age>56.0</age>
    <age_units>YR</age_units>
    <gender>F</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2006-10-31</report_date>
    <reporter_occupation>CN</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"/>
    <reaction reaction_preferred_term="AGGRESSION"/>
    <reaction reaction_preferred_term="ANGER"/>
    <reaction reaction_preferred_term="MOOD SWINGS"/>
    <reaction reaction_preferred_term="OBSESSIVE-COMPULSIVE DISORDER"/>
    <reaction reaction_preferred_term="SUICIDAL IDEATION"/>
    <drug_datum>
      <drug_sequence>1007809099</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>WELLBUTRIN XL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021515</nda_number>
      <drug_indication indication_preferred_term="DEPRESSION
"/>
      <therapy>
        <start_date>2006-01-01</start_date>
        <end_date>2006-10-26</end_date>
        <duration>10.0</duration>
        <duration_units>MON</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1007809100</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PAXIL</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>1007809101</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CARAFATE</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>1007809102</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PRILOSEC</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>1007809103</drug_sequence>
      <role_code>C</role_code>
      <drug_name>XANAX</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>1007809104</drug_sequence>
      <role_code>C</role_code>
      <drug_name>VITAMIN B-12</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>1007809105</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ASCORBIC ACID</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>1007809106</drug_sequence>
      <role_code>C</role_code>
      <drug_name>VITAMIN E</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>1007809107</drug_sequence>
      <role_code>C</role_code>
      <drug_name>MULTI-VITAMIN</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>1007809108</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CHANTIX</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>1007809109</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FLEX-A-MIN</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>1007809110</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PAREGORIC</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>1007809111</drug_sequence>
      <role_code>C</role_code>
      <drug_name>UNSPECIFIED MEDICATION</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>07Q1</yyqq>
    <isr>5272736</isr>
    <initial_followup_code>F</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5272736-4</image>
    <event_date>2006-02-01</event_date>
    <manufacturer_date>2007-03-21</manufacturer_date>
    <fda_date>2007-03-22</fda_date>
    <report_code>EXP</report_code>
    <manufacturer_number>US-GLAXOSMITHKLINE-A0625184A</manufacturer_number>
    <manufacturer_sending>GLAXOSMITHKLINE</manufacturer_sending>
    <age>56.0</age>
    <age_units>YR</age_units>
    <gender>F</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2007-03-22</report_date>
    <reporter_occupation>CN</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"/>
    <reaction reaction_preferred_term="AGGRESSION"/>
    <reaction reaction_preferred_term="ANGER"/>
    <reaction reaction_preferred_term="BIPOLAR DISORDER"/>
    <reaction reaction_preferred_term="MOOD SWINGS"/>
    <reaction reaction_preferred_term="OBSESSIVE-COMPULSIVE DISORDER"/>
    <reaction reaction_preferred_term="SUICIDAL IDEATION"/>
    <drug_datum>
      <drug_sequence>1008279090</drug_sequence>
      <role_code>PS</role_code>
      <drug_name>WELLBUTRIN XL</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>ORAL</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021515</nda_number>
      <drug_indication indication_preferred_term="DEPRESSION
"/>
      <therapy>
        <start_date>2006-01-01</start_date>
        <end_date>2006-10-26</end_date>
        <duration>10.0</duration>
        <duration_units>MON</duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1008279091</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PAXIL</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>1008279092</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CARAFATE</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>1008279093</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PRILOSEC</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>1008279094</drug_sequence>
      <role_code>C</role_code>
      <drug_name>XANAX</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>1008279095</drug_sequence>
      <role_code>C</role_code>
      <drug_name>VITAMIN B-12</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>1008279096</drug_sequence>
      <role_code>C</role_code>
      <drug_name>ASCORBIC ACID</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>1008279097</drug_sequence>
      <role_code>C</role_code>
      <drug_name>VITAMIN E</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>1008279098</drug_sequence>
      <role_code>C</role_code>
      <drug_name>MULTI-VITAMIN</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>1008279099</drug_sequence>
      <role_code>C</role_code>
      <drug_name>CHANTIX</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>1008279100</drug_sequence>
      <role_code>C</role_code>
      <drug_name>FLEX-A-MIN</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>1008279101</drug_sequence>
      <role_code>C</role_code>
      <drug_name>PAREGORIC</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>1008279102</drug_sequence>
      <role_code>C</role_code>
      <drug_name>UNSPECIFIED MEDICATION</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_case>
