Follow-up of cardiovascular adverse events after smallpox vaccination among civilians in the United States, 2003.
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 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.
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ABSTRACT: Background: The herpes zoster vaccine is effective in preventing herpes zoster and postherpetic neuralgia in immunocompetent older adults. However, its safety has not been described in depth. Objective: To describe local adverse effects and short- and longterm safety profiles of herpes zoster vaccine in immunocompetent older adults. Design: Randomized, placebo-controlled trial with enrollment from November 1998 to September 2001 and follow-up through April 2004 (mean, 3.4 years). A Veterans Affairs Coordinating Center generated the permutated block randomization scheme, which was stratified by site and age. Participants and follow-up study personnel were blinded to treatment assignments. (ClinicalTrials.gov registration number: NCT00007501 Setting: 22 U.S. academic centers. Participants: 38 546 immunocompetent adults 60 years or older, including 6616 who participated in an adverse events substudy. Intervention: Single dose of herpes zoster vaccine or placebo. Measurements: Serious adverse events and rashes in all participants and inoculation-site events in substudy participants during the first 42 days after inoculation. Thereafter, vaccination-related serious adverse events and deaths were monitored in all participants, and hospitalizations were monitored in substudy participants. Results: After inoculation, 255 (1.4%) vaccine recipients and 254 (1.4%) placebo recipients reported serious adverse events. Local inoculation-site side effects were reported by 1604 (48%) vaccine recipients and 539 (16%) placebo recipients in the substudy. A total of 977 (56.6%) of the vaccine recipients reporting local side effects were aged 60 to 69 years, and 627 (39.2%) were older than 70 years. After inoculation, herpes zoster occurred in 7 vaccine recipients versus 24 placebo recipients. Long-term follow-up (mean, 3.39 years) showed that rates of hospitalization or death did not differ between vaccine and placebo recipients. Limitations: Participants in the substudy were not randomly selected. Confirmation of reported serious adverse events with medical record data was not always obtained. Conclusion: Herpes zoster vaccine is well tolerated in older, immunocompetent adults.Annals of internal medicine 05/2010; 152(9):545. · 16.10 Impact Factor
Article: Myocardial Effects of IMVAMUNE.Biosecurity and bioterrorism: biodefense strategy, practice, and science 07/2014; 12(4):217-218. · 1.64 Impact Factor
Article: Smallpox Vaccines and Eczema.Biosecurity and bioterrorism: biodefense strategy, practice, and science 07/2014; 12(4):218. · 1.64 Impact Factor