Article

Follow‐Up of Cardiovascular Adverse Events after Smallpox Vaccination among Civilians in the United States, 2003

National Immunization Program, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Clinical Infectious Diseases (Impact Factor: 8.89). 04/2008; 46 Suppl 3(s3):S251-7. DOI: 10.1086/524741
Source: PubMed

ABSTRACT

Limited information exists regarding intermediate or long-term consequences of cardiac adverse events (CAEs) after smallpox
vaccination. We conducted follow up at 5–12 months after vaccination of 203 US civilian vaccinees who reported a possible
CAE. Among 31 of the 33 with confirmed CAEs, at least 1 health-related quality-of-life change persisted for ∼48%; ∼87% missed
work (average, 11.5 days). Among 168 of the 170 case patients with other reported cardiovascular conditions, at least 1 health-related
quality-of-life change persisted for ∼40%; almost 49% missed work (average, 10.2 days). Almost all vaccinees with possible
CAEs were working the same number of hours at follow-up compared with before vaccination. Although intermediate-term consequences
among possible postvaccination CAEs were not considered serious, lost days of work and a decline in health-related quality
of life at the time of follow-up were common, resulting in personal economic and quality-of-life burden.

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Available from: David L Swerdlow, Jan 11, 2016
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    • "Smallpox vaccine has been administered to millions of individuals and many short-term adverse health effects associated with smallpox vaccination have been documented from earlier investigations and more recent Department of Health and Human Services investigations [5] [6]. Cases of myopericarditis and other cardiac disease occurring within 6 weeks of vaccination [7] [8] [9] and of dilated cardiomyopathy identified within 5–29 weeks after vaccination [10] have been of concern [5] [11] [12]. The DoD, in conjunction with the Centers for Disease Control and Prevention and the US Food and Drug Administration, continues to monitor short-term adverse events associated with the administration of vaccines through the Vaccine Adverse Events Reporting System (VAERS) [13]. "
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    ABSTRACT: In December 2002, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and the Department of Defense Armed Forces Epidemiological Board formed a joint Smallpox Vaccine Safety Working Group (SVS WG) to provide independent safety oversight for smallpox vaccination safety-monitoring systems. From January 2003 through June 2004, the SVS WG reviewed individual and aggregate safety data on postvaccination adverse events. Serious adverse events were rare because of careful education, prevaccination screening, and strict attention to vaccination-site management. Recent vaccinees safely cared for high-risk patients, adhering to recommended site care. Human immunodeficiency virus—infected individuals without severe immunosuppression had uncomplicated vaccination reactions. Epidemiological studies supported a causal relationship between myocarditis and/or pericarditis and smallpox vaccination. Data supported neutrality regarding hypothesized causal associations between vaccination and dilated cardiomyopathy or ischemic cardiac disease. The SVS WG concurs with recommendations to defer from vaccination any person with ⩾3 ischemic cardiac disease risk factors.
    Full-text · Article · Mar 2008 · Clinical Infectious Diseases
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    ABSTRACT: The following introduction describes the context in which the national smallpox vaccination program was implemented and highlights the significance of the key policy, programmatic, or scientific challenges, observations, and lessons learned that are presented in the articles that follow within this supplement to Clinical Infectious Diseases. Although the execution of this national program posed multiple complex and varied challenges, the focus of this supplement is on vaccine-associated adverse events and vaccine safety.
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