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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Evaluating the Safety of Influenza and Pneumococcal Vaccines Received by the Medicare Population

Principal Investigator: Dale R. Burwen, MS
Office / Division: OBE / DE


Public Health Issue: Immunization against influenza infection and pneumococcal disease is a critical preventive intervention that can decrease the risk of hospitalization and death, especially in high risk persons such as the elderly. Side effects from vaccines are generally mild and self-limited. However, serious adverse medical events following vaccination are sometimes reported to the national Vaccine Adverse Event Reporting System (VAERS), or published as case reports in the medical literature. Such passively obtained reports generally can be used to raise hypotheses about the association between the vaccine and the event, but are not sufficient to support a conclusion of a causal association. Evaluations using controlled designs are needed, but databases of sufficient size needed to evaluate relatively rare events and that focus on the elderly, who may be at higher risk of severe morbidity if adverse events occur, are limited. Data from the Medicare program, which covers more than 40 million persons, provide a unique opportunity to evaluate these issues.

Regulatory Contribution: It is important to be able to evaluate concerns about whether serious adverse events are caused by a vaccine.

Research Approach: This is a joint project between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). Data from the Medicare program are used to determine whether hospitalization for certain adverse events is associated with receipt of influenza or pneumococcal vaccine. Controlled observational designs are used to evaluate hypothesized associations. Also, the rate of occurrence and risk factors for certain adverse events that are known to be associated with vaccination (e.g., severe injection site reactions) may be determined.

Mission Relevance and Outcomes: This project will provide knowledge about whether certain serious adverse events are associated with influenza or pneumococcal vaccine, and the rate of occurrence, if applicable. If no true adverse reaction is found, the data will provide reassurance about the safety of the vaccines.


J Pediatr 2005 Nov;147(5):640-644
Transient Bulging Fontanelle after Vaccination: Case Report and Review of the Vaccine Adverse Event Reporting System.
Freedman SB, Reed J, Burwen DR, Wise RP, Weiss A, Ball R

Pharmacoepidemiol Drug Saf 2005 Sep;14(9):601-9
Comparing data mining methods on the VAERS database.
Banks D, Woo EJ, Burwen DR, Perucci P, Braun MM, Ball R

Clin Infect Dis 2004 Mar 15;38(6):771-9
Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.
Begier EM, Burwen DR, Haber P, Ball R, Vaccine Adverse Event Reporting System Working Group


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Silver Spring, MD 20993-0002