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American Journal of Epidemiology 2004 160(7):642-651; doi:10.1093/aje/kwh269
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Copyright © 2004 by the Johns Hopkins Bloomberg School of Public Health

ORIGINAL CONTRIBUTIONS

Myopericarditis following Smallpox Vaccination

Mark K. Arness1, Robert E. Eckart2, Suzanne S. Love3, J. Edwin Atwood4, Timothy S. Wells5, Renata J. M. Engler6, Limone C. Collins6, Sharon L. Ludwig7, James R. Riddle8 , John D. Grabenstein9 and David N. Tornberg10 for the Department of Defense Smallpox Vaccination Clinical Evaluation Team

1 Army Medical Surveillance Activity, Washington, DC.
2 Brooke Army Medical Center, Fort Sam Houston, TX.
3 Regional Vaccine Healthcare Center, Naval Medical Center, Portsmouth, VA.
4 Walter Reed Army Medical Center, Washington, DC.
5 Naval Health Research Center, San Diego, CA.
6 Vaccine Healthcare Center Network, Walter Reed Army Medical Center, Washington, DC.
7 US Coast Guard Health and Safety Directorate, Washington, DC.
8 Air Force Research Laboratories, Wright-Patterson Air Force Base, OH.
9 Military Vaccine Agency, US Army Medical Command, Falls Church, VA.
10 Office of the Assistant Secretary of Defense for Health Affairs, Falls Church, VA.

Myopericarditis has been a rare or unrecognized event after smallpox vaccinations with the New York City Board of Health strain of vaccinia virus (Dryvax; Wyeth Laboratories, Marietta, Pennsylvania). In this article, the authors report an attributable incidence of at least 140 clinical cases of myopericarditis per million primary smallpox vaccinations with this strain of vaccinia virus. Fifty-eight males and one female aged 21–43 years with confirmed or probable acute myopericarditis were detected following vaccination of 492,730 US Armed Forces personnel from December 15, 2002, through September 30, 2003. The cases were identified through sentinel reporting to military headquarters, active surveillance using the Defense Medical Surveillance System, or reports to the Vaccine Adverse Event Reporting System. The observed incidence (16.11/100,000) of myopericarditis over a 30-day observation window among 347,516 primary vaccinees was nearly 7.5-fold higher than the expected rate of 2.16/100,000 (95% confidence interval: 1.90, 2.34) among nonvaccinated, active-duty military personnel, while the incidence of 2.07/100,000 among 145,155 revaccinees was not statistically different from the expected background rate. The cases were predominantly male (58/59; 98.3%) and White (51/59; 86.4%), both statistically significant associations (p = 0.0147 and p = 0.05, respectively).

military personnel; myocarditis; pericarditis; smallpox; vaccination; vaccinia virus

Abbreviations: Abbreviations: CDC, Centers for Disease Control and Prevention; DMSS, Defense Medical Surveillance System; DoD, US Department of Defense.


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