Pneumococcal Conjugate Vaccines and Kawasaki Disease

Basic Details
Date Posted
Thursday, May 29, 2014
Medical Product
13-valent pneumococcal vaccine (PCV13)
7-valent pneumococcal conjugate vaccine (PCV7)
generic pneumococcal conjugate vaccine (PCV)
Health Outcome(s)
Kawasaki disease

Modular program-based one-time assessment of pneumococcal conjugate vaccines (PCV7, PCV13, Generic PCV) and Kawasaki’s. Results include prevalent and incident use of pneumococcal conjugate vaccines, prevalent and incident Kawasaki’s disease diagnoses, and diagnoses of Kawasaki's Disease following incident vaccination with pneumococcal conjugate vaccines.  The query was run against the Mini-Sentinel Distributed Database for the time period of interest January 1, 2004 through March 31, 2012.  Modular programs are adaptable standardized programs.  Results were generated using Modular Program 5, version 2.1; and Modular Program 3, version 2.5; click here for more information. The queries were distributed in August/September 2012.  This report includes data from 4 Data Partners.

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Additional Details
FDA Center
Time Period
January 1, 2004 - March 31, 2012
Study Type
Modular Program
Assessment Type
Exploratory Analyses
Data Sources
Mini-Sentinel Distributed Database (MSDD)