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 approximately 48%; approximately 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 approximately 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.
"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  . Cases of myopericarditis and other cardiac disease occurring within 6 weeks of vaccination    and of dilated cardiomyopathy identified within 5–29 weeks after vaccination  have been of concern   . 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) . "
[Show abstract][Hide abstract] ABSTRACT: This study explores adverse events severe enough to warrant hospitalization that may have been associated with receiving the smallpox vaccine in conjunction with military service. Cox proportional hazards modeling was used to identify the risk of hospitalization among US active-duty military personnel during a 1-year period following receipt of the smallpox vaccine. The reference group consisted of active-duty military personnel who also received the smallpox vaccine after the conclusion of their health care observation period, allowing for comparison to a temporally and demographically similar population. The risk of hospitalization was slightly elevated among the postvaccine group for any-cause hospitalization and for hospitalization in several broad diagnostic categories. Hospitalizations for asthma, autoimmune diseases, and myopericarditis, were more likely in the postvaccine group. The increased risk of hospitalization for varied outcomes does not necessarily imply a cause-effect relationship, but it does offer areas for more focused study, using longitudinal data to explore the long-term impact of smallpox vaccination on the health of young adults.
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] ABSTRACT: Myocarditis was reported after smallpox vaccination in Europe and Australia, but no association had been reported with the US vaccine. We conducted surveillance to describe and determine the frequency of myocarditis and/or pericarditis (myo/pericarditis) among civilians vaccinated during the US smallpox vaccination program between January and October 2003. We developed surveillance case definitions for myocarditis, pericarditis, and dilated cardiomyopathy after smallpox vaccination. We identified 21 myo/pericarditis cases among 37,901 vaccinees (5.5 per 10,000); 18 (86%) were revacinees, 14 (67%) were women, and the median age was 48 years (range, 25-70 years). The median time from vaccination to onset of symptoms was 11 days (range, 2-42 days). Myo/pericarditis severity was mild, with no fatalities, although 9 patients (43%) were hospitalized. Three additional vaccinees were found to have dilated cardiomyopathy, recognized within 3 months after vaccination. We describe an association between smallpox vaccination, using the US vaccinia strain, and myo/pericarditis among civilians.
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