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Vaccine. 2014 Aug 20;32(37):4758-65. doi: 10.1016/j.vaccine.2014.06.034. Epub 2014 Jun 18.

Ischemic cardiac events and other adverse events following ACAM2000(®) smallpox vaccine in the Vaccine Adverse Event Reporting System.

Author information

1
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States. Electronic address: mmm2@cdc.gov.
2
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
3
Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
4
Vaccine Healthcare Centers Network, Military Vaccine Agency, US Army Public Health Command, Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD 20889-5600, United States.
5
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, United States.

Abstract

BACKGROUND:

The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all US licensed vaccines. In March 2008, ACAM2000(®) replaced Dryvax(®) as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000(®).

METHODS:

During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000(®)and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA(®)) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions.

RESULTS:

VAERS received 1149 reports following ACAM2000(®) administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA(®) search found 31 reports of possible ICE after receipt of ACAM2000(®) vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases.

CONCLUSIONS:

Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000(®). Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon.

KEYWORDS:

ACAM2000(®); Ischemic cardiac events; Myo/pericarditis; Myocarditis; Pericarditis

PMID:
24951868
DOI:
10.1016/j.vaccine.2014.06.034
[Indexed for MEDLINE]
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