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Mini-Sentinel: Vaccine Safety Monitoring - Data Characterization

    Basic Details
    Date Posted
    Status
    Complete
    Description

    This activity characterizes the capability of the Mini-Sentinel Distributed Database (MSDD) to support active surveillance for vaccine safety. Specifically, investigators analyzed aggregated data from participating Mini-Sentinel Data Partners to better understand the strengths and limitations of this novel active surveillance system. This is one of the vaccine-related Mini-Sentinel activities collectively described as PRISM (Postlicensure Rapid Immunization Safety Monitoring).

    Information
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Meghan A. Baker, MD, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School and Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA

    Tracy A. Lieu, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School

    Workgroup Member(s)

    David Cole, BM; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School

    Grace M. Lee, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School and Division of Infectious Diseases, Department of Medicine, Boston Children's Hospital, Boston, MA

    Michael Nguyen, MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD