Anaphylaxis Events Following Incident Vaccine Exposure Among Members with a Pre-Existing Condition of Milk Allergy

    Basic Details
    Date Posted
    Tuesday, March 3, 2015
    Status
    Complete
    Medical Product
    diphtheria, tetanus, acellular pertussis (DTaP) vaccine
    diphtheria, tetanus, acellular pertussis (DTaP)-haemophilus influenzae type B (HIB) vaccine
    diphtheria, tetanus, acellular pertussis (DTaP)-haemophilus influenzae type B (HIB)-inactivated polio vaccine (IPV)
    diphtheria, tetanus, acellular pertussis (DTaP)-hepatitis B (Hep B)-inactivated polio vaccine (IPV)
    diphtheria, tetanus, acellular pertussis (DTaP)-inactivated polio vaccine (IPV)
    tetanus, diphtheria, pertussis (Tdap) vaccine
    Health Outcome(s)
    anaphylactic shock
    Description

    Modular program-based one-time assessment to investigate anaphylaxis events following incident exposure to several vaccinations among members with a pre-existing condition of milk allergy or anaphylaxis due to milk products. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2000 through December 31, 2010.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 2.0; click here for more information.  Queries were distributed in April 2012. This report includes data from 4 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2000 - December 31, 2010
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)