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

Project Title Anaphylaxis Events Following Incident Vaccine Exposure Among Members with a Pre-Existing Condition of Milk Allergy
Date Posted
Tuesday, March 3, 2015
Project ID
MSY3_MPR14
Status
Complete
Deliverables
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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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
anaphylactic shock
Time Period
January 1, 2000 - December 31, 2010
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER