Skip to main content

Pneumococcal Conjugate Vaccines and Kawasaki Disease

    Basic Details
    Date Posted
    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.

    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to

    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

    Additional Details
    FDA Center
    Time Period
    January 1, 2004 - March 31, 2012
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)