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Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018
John R Su1, Michael M McNeil1, Kerry J Welsh2
1Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Background:
Myopericarditis after vaccination has been sporadically reported in the medical literature. Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States.
Methods:
We identified U.S. reports of myopericarditis received by VAERS during 1990-2018 that met a published case definition for myopericarditis or were physician-diagnosed. We stratified analysis by age group (<19, 19-49, ≥50 years), describing reports by serious/non-serious status, sex, time to symptom onset after vaccination, vaccine(s) administered, and exposure to other known causes of myopericarditis. We used Empirical Bayesian data mining to detect disproportionate reporting of myopericarditis after vaccination.
Results:
VAERS received 620,195 reports during 1990-2018: 708 (0.1%) met the case definition or were physician-diagnosed as myopericarditis. Most (79%) myopericarditis reports described males; 69% were serious; 72% had symptom onset ≤ 2 weeks postvaccination. Overall, smallpox (59%) and anthrax (23%) vaccines were most commonly reported. By age, among persons aged < 19 years, Haemophilus influenzae type b (22, 22%) and hepatitis B (18, 18%); among persons aged 19-49 years smallpox (387, 79%); among persons aged ≥ 50 years inactivated influenza (31, 36%) and live attenuated zoster (19, 22%) vaccines were most commonly reported. The vaccines most commonly reported remained unchanged when excluding 138 reports describing other known causes of myopericarditis. Data mining revealed disproportionate reporting of myopericarditis only after smallpox vaccine.
Conclusions:
Despite the introduction of new vaccines over the years, myopericarditis remains rarely reported after vaccines licensed for use in the United States. In this analysis, myopericarditis was most commonly reported after smallpox vaccine, and less commonly after other vaccines.
Insights
Myopericarditis is rarely reported after U.S. vaccines. Analysis of vaccine safety data found smallpox vaccine had the most reports, while other vaccines showed rare instances.
Area of Science:
- Vaccine safety surveillance
- Immunology
- Public health
Background:
- Myopericarditis following vaccination is infrequently documented in medical literature.
- This study analyzes reports of myopericarditis post-vaccination submitted to the Vaccine Adverse Event Reporting System (VAERS) in the United States.
Purpose of the Study:
- To conduct a comprehensive descriptive analysis of myopericarditis cases reported after vaccination.
- To identify specific vaccines associated with myopericarditis and analyze reporting trends over time.
Main Methods:
- Utilized U.S. VAERS data from 1990-2018 for myopericarditis cases meeting specific definitions.
- Stratified analyses by age, report seriousness, sex, time to onset, vaccine type, and co-exposure to other causes.
- Employed Empirical Bayesian data mining to detect disproportionate reporting of myopericarditis.
Main Results:
- Out of 620,195 VAERS reports, 708 (0.1%) were identified as myopericarditis.
- Most cases involved males (79%), were serious (69%), and had symptom onset within 2 weeks post-vaccination.
- Smallpox (59%) and anthrax (23%) vaccines were most frequently reported; disproportionate reporting was observed only for smallpox vaccine.
Conclusions:
- Myopericarditis remains a rare adverse event following vaccination in the U.S.
- Smallpox vaccine was associated with the highest number of myopericarditis reports, with other vaccines showing infrequent occurrences.
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