<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7131361">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6377697</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6377697-2</image>
    <event_date>2008-07-01</event_date>
    <manufacturer_date>2009-09-17</manufacturer_date>
    <fda_date>2009-09-25</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-aventis-200918428us</manufacturer_number>
    <manufacturer_sending>sanofi-aventis</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>99.79</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-09-25</report_date>
    <reporter_occupation>cn</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ds"/>
    <reaction reaction_preferred_term="arthritis"/>
    <reaction reaction_preferred_term="wheelchair user"/>
    <drug_datum>
      <drug_sequence>1012335543</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>lantus</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>c450</lot_number>
      <expiration_date></expiration_date>
      <nda_number>021081</nda_number>
      <drug_indication indication_preferred_term="diabetes mellitus"/>
      <therapy>
        <start_date>2008-07-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335544</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lisinopril</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>1012335545</drug_sequence>
      <role_code>c</role_code>
      <drug_name>norvasc</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>1012335546</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>1012335547</drug_sequence>
      <role_code>c</role_code>
      <drug_name>vitamin b nos</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>1012335548</drug_sequence>
      <role_code>c</role_code>
      <drug_name>multi-vitamins</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>1012335549</drug_sequence>
      <role_code>c</role_code>
      <drug_name>klor-con</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>1012335550</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>1012335551</drug_sequence>
      <role_code>c</role_code>
      <drug_name>bufferin</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>
