<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6647715">
  <adverse_event_report>
    <yyqq>08Q2</yyqq>
    <isr>5747609</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5747609-0</image>
    <event_date>2004-12-08</event_date>
    <manufacturer_date>2008-05-19</manufacturer_date>
    <fda_date>2008-05-23</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-astrazeneca-2006uw24280</manufacturer_number>
    <manufacturer_sending>azproduw00</manufacturer_sending>
    <age>86.0397</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2008-05-23</report_date>
    <reporter_occupation></reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="DE"/>
    <outcome outcome_code="OT"/>
    <reaction reaction_preferred_term="DEATH"/>
    <reaction reaction_preferred_term="PANCREATITIS"/>
    <drug_datum>
      <drug_sequence>1009945529</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>seroquel</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>020639</nda_number>
      <drug_indication indication_preferred_term="DEPRESSION"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1009945530</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zyprexa</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>09Q3</yyqq>
    <isr>6287779</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6287779-1</image>
    <event_date>2004-12-08</event_date>
    <manufacturer_date>2007-07-03</manufacturer_date>
    <fda_date>2009-07-29</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-astrazeneca-2006uw24280</manufacturer_number>
    <manufacturer_sending>azproduw00</manufacturer_sending>
    <age>86.0397</age>
    <age_units>YR</age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>45.4</weight>
    <weight_units>KG</weight_units>
    <report_date>2009-07-29</report_date>
    <reporter_occupation></reporter_occupation>
    <death_date>2005-02-14</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="acute myocardial infarction"/>
    <reaction reaction_preferred_term="coronary artery disease"/>
    <reaction reaction_preferred_term="pancreatitis"/>
    <drug_datum>
      <drug_sequence>1011963602</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>seroquel</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>020639</nda_number>
      <drug_indication indication_preferred_term="depression"/>
      <therapy>
        <start_date>2002-05-24</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963603</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>seroquel</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>020639</nda_number>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963604</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zyprexa</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></nda_number>
      <therapy>
        <start_date>1998-02-14</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963605</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zyprexa</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>1011963606</drug_sequence>
      <role_code>c</role_code>
      <drug_name>hydrochlorothiazide</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></nda_number>
      <therapy>
        <start_date>1998-02-14</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963607</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lotrel</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></nda_number>
      <therapy>
        <start_date>1998-02-14</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963608</drug_sequence>
      <role_code>c</role_code>
      <drug_name>trimethoprim</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></nda_number>
      <therapy>
        <start_date>2004-04-12</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963609</drug_sequence>
      <role_code>c</role_code>
      <drug_name>aricept</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></nda_number>
      <drug_indication indication_preferred_term="dementia alzheimer's type"/>
      <therapy>
        <start_date>2004-04-12</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963610</drug_sequence>
      <role_code>c</role_code>
      <drug_name>vasotec</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></nda_number>
      <therapy>
        <start_date>2004-09-27</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963611</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lomotil</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></nda_number>
      <therapy>
        <start_date>2004-09-27</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963612</drug_sequence>
      <role_code>c</role_code>
      <drug_name>coumadin</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></nda_number>
      <drug_indication indication_preferred_term="anticoagulant therapy"/>
      <therapy>
        <start_date>2002-05-21</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963613</drug_sequence>
      <role_code>c</role_code>
      <drug_name>remeron</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></nda_number>
      <therapy>
        <start_date>2002-05-21</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963614</drug_sequence>
      <role_code>c</role_code>
      <drug_name>provigil</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></nda_number>
      <therapy>
        <start_date>2004-12-07</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963615</drug_sequence>
      <role_code>c</role_code>
      <drug_name>toprol-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></nda_number>
      <therapy>
        <start_date>2004-12-07</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011963616</drug_sequence>
      <role_code>c</role_code>
      <drug_name>temazepam</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></nda_number>
      <drug_indication indication_preferred_term="insomnia"/>
      <therapy>
        <start_date>1998-02-26</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
