A Prospective Study of the Incidence of Myocarditis/Pericarditis and New Onset Cardiac Symptoms following Smallpox and Influenza Vaccination
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BACKGROUND: Although myocarditis/pericarditis (MP) has been identified as an adverse event following smallpox vaccine (SPX), the prospective incidence of this reaction and new onset cardiac symptoms, including possible subclinical injury, has not been prospectively defined. PURPOSE: The study's primary objective was to determine the prospective incidence of new onset cardiac symptoms, clinical and possible subclinical MP in temporal association with immunization. METHODS: New onset cardiac symptoms, clinical MP and cardiac specific troponin T (cTnT) elevations following SPX (above individual baseline values) were measured in a multi-center prospective, active surveillance cohort study of healthy subjects receiving either smallpox vaccine or trivalent influenza vaccine (TIV). RESULTS: New onset chest pain, dyspnea, and/or palpitations occurred in 10.6% of SPX-vaccinees and 2.6% of TIV-vaccinees within 30 days of immunization (relative risk (RR) 4.0, 95% CI: 1.7-9.3). Among the 1081 SPX-vaccinees with complete follow-up, 4 Caucasian males were diagnosed with probable myocarditis and 1 female with suspected pericarditis. This indicates a post-SPX incidence rate more than 200-times higher than the pre-SPX background population surveillance rate of myocarditis/pericarditis (RR 214, 95% CI 65-558). Additionally, 31 SPX-vaccinees without specific cardiac symptoms were found to have over 2-fold increases in cTnT (>99th percentile) from baseline (pre-SPX) during the window of risk for clinical myocarditis/pericarditis and meeting a proposed case definition for possible subclinical myocarditis. This rate is 60-times higher than the incidence rate of overt clinical cases. No clinical or possible subclinical myocarditis cases were identified in the TIV-vaccinated group. CONCLUSIONS: Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization. Evidence of subclinical transient cardiac muscle injury post-vaccinia immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.
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Myocarditis has been reported as a rare adverse event for other vaccines before the COVID-19 pandemic, mainly smallpox vaccines.
“Myocarditis has been reported as a rare adverse event for other vaccines before the COVID-19 pandemic, mainly smallpox vaccines. 189,190”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [190]
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- Authors
- Engler, R. J. M., Nelson, M. R., Collins Jr., L. C., Spooner, C., Hemann, B. A., Gibbs, B. T., Atwood, J. E., Howard, R. S., Chang, A. S., Cruser, D. L., Gates, D. G., Vernalis, M. N., Lengkeek, M. S., McClenathan, B. M., Jaffe, A. S., Cooper, L. T., Black, S., Carlson, C., Wilson, C., & Davis, R. L.
- Affiliations
- Uniformed Services University of the Health Sciences (US)
- Defense Health Agency (US)
- Walter Reed National Military Medical Center (US)
- Vassar Brothers Medical Center (US)
- Alexander T. Augusta Military Medical Center (US)
- Womack Army Medical Center (US)
- Mayo Clinic (US)
- Fred Hutch Cancer Center (US)
- University of Washington (US)
- Oak Ridge National Laboratory (US)
- Corresponding author
- Engler, Renata J. M.
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2015-03-20
- Volume
- 10
- Issue
- 3
- Pages
- e0118283
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4368609
- OpenAlex
- W2078712489
- Cited by
- 169
- References
- 52
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 11 · 2023: 27 · 2022: 51 · 2021: 32 · 2020: 10 · 2019: 3 · 2018: 14 · 2017: 5 · 2016: 7 · 2015: 2
- FWCI
- 6.79
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- public-domain
- creativecommons.org/publicdomain/zero/1.0/ (vor)
- Locations
- PLoS ONE (publishedVersion, public-domain)
- Europe PMC (PubMed Central) (publishedVersion, public-domain)
- PubMed Central (publishedVersion, public-domain)
- PubMed (publishedVersion)
- OSTI OAI (U.S. Department of Energy Office of Scientific and Technical Information) (submittedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- U.S. Department of Defense
- National Institutes of Health (n01ai40069-7-0-1)
- U.S. Public Health Service (200-2002-00732)
- Walter Reed National Military Medical Center
- National Institute of Allergy and Infectious Diseases (N01 AI40069, N01 AI040069, HHSN272201000024C)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
- Life Sciences › Immunology and Microbiology › Virology › Poxvirus research and outbreaks
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Pericarditis and Cardiac Tamponade
- Keywords
- myocarditis, pericarditis, smallpox vaccine, trivalent influenza vaccine, vaccine adverse events, cardiac symptoms, subclinical myocarditis, cardiac troponin T, chest pain, dyspnea, palpitations, vaccine safety surveillance, incidence
- MeSH terms
- Adult, Demography, Female, Humans, Influenza Vaccines, Male, Myocarditis, Pericarditis, Prospective Studies, Smallpox Vaccine, United States, Vaccination, Vaccines, Inactivated, Cohort Studies, Incidence, Treatment Outcome, Troponin T
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