Disentangling a Thorny Issue: Myocarditis and Pericarditis Post COVID-19 and Following mRNA COVID-19 Vaccines
Open accessAbstract
Considering the clinical significance for myocarditis and pericarditis after immunization with mRNA COVID-19 vaccines, the present pharmacovigilance study aimed to describe these events reported with mRNA COVID-19 vaccines in the Vaccine Adverse Events Reporting System (VAERS). From 1990 to July 2021, the mRNA vaccines were the most common suspected vaccines related to suspected cases of myocarditis and/or pericarditis (myocarditis: N = 1,165; 64.0%; pericarditis: N = 743; 55.1%), followed by smallpox vaccines (myocarditis: N = 222; 12.2%; pericarditis: N = 200; 14.8%). We assessed all suspected cases through the case definition and classification of the Brighton Collaboration Group, and only definitive, probable, and possible cases were included in the analysis. Our findings suggested that myocarditis and pericarditis mostly involve young male, especially after the second dose with a brief time to onset. Nevertheless, this risk is lower (0.38/100,000 vaccinated people; 95% CI 0.36–0.40) than the risk of developing myocarditis after SARS-CoV-2 infection (1000–4000 per 100,000 people) and the risk of developing “common” viral myocarditis (1–10 per 100,000 people/year). Comparing with the smallpox vaccine, for which is already well known the association with myocarditis and pericarditis, our analysis showed a lower probability of reporting myocarditis (ROR 0.12, 95% CI 0.10–0.14) and pericarditis (ROR 0.06, 95% CI 0.05–0.08) following immunization with mRNA COVID-19 vaccines.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
COVID-19-associated myocarditis incidence ranged from 150 to 4000 cases per 100,000 individuals.
“with COVID ranging from 150 to 4000 cases/100 000 individuals”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The paper's abstract (p. 1) gives 1000–4000 cases per 100,000 people for myocarditis after SARS-CoV-2 infection. The claimed upper bound matches, but the source gives 1000—not 150—as the lower bound. (LLM, conf=0.90)
Experimental — accuracy not yet measuredPre-COVID incidence of myocarditis was reported at 1 to 10 cases per 100,000 individuals.
“The incidence of myocarditis pre-COVID was reported at 1 to 10 cases/100 000 individuals”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The Conclusions (p. 10) give the figure of 1–10 per 100,000 people per year, but specifically for “common” viral myocarditis. The citing sentence presents it as the incidence of myocarditis generally before COVID and omits the annual time frame. (LLM, conf=0.83)
Experimental — accuracy not yet measuredSARS-CoV-2 increased the incidence of myocarditis/pericarditis at least 15-fold over pre-COVID levels, although the condition remains rare.
“Many epidemiologic studies have been conducted since that time concluding that SARS-CoV-2 increased the incidence of myocarditis/pericarditis at least 15× over pre-COVID levels although the condition remains rare.”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The Conclusions (p. 10) report a higher risk of myocarditis and cardiac injury after SARS-CoV-2 infection than of common viral myocarditis. They do not establish a 15-fold increase over pre-COVID incidence, and the infection figure includes cardiac injury rather than reporting a combined myocarditis/pericarditis incidence. The paper also does not characterize the post-infection condition as rare. (LLM, conf=0.84)
Experimental — accuracy not yet measured38.1% of cases were reported for ages 12 to 20 and <5% for those over 60 years; 60.1% were reported after the second dose regardless of vaccine platform.
“Of the cases, 38.1% were reported for ages 12 to 20 and <5% for those over 60 years; 60.1% were reported after the second dose regardless of the vaccine platform.”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The Results (p. 5) report 38.1% of cases in ages 12–20 and 60.1% after the second dose. They describe the older group as vaccinees above 61 with ≤5% of cases, rather than people over 60 with <5%. The analysis concerns mRNA vaccines, so it does not establish the second-dose figure regardless of vaccine platform. (LLM, conf=0.88)
Experimental — accuracy not yet measured67.9% of myocarditis or pericarditis cases were related to mRNA vaccines; smallpox vaccines were next most common.
“They found that 67 .9% of myocarditis or pericarditis cases were related to mRNA vaccines. Smallpox vaccines were next most common followed by other vaccine platforms.”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The Results (p. 3) identify mRNA vaccines as the most common suspected vaccines in reported myocarditis and pericarditis cases, followed by smallpox vaccines. But they give separate mRNA figures of 64.0% for myocarditis and 55.1% for pericarditis, not the claimed 67.9%; these are suspected associations in reports, not established causes. (LLM, conf=0.90)
Experimental — accuracy not yet measured
A comprehensive study identified 1841 definitive, probable, or possible cases out of 1,048,575 individuals from vaccines passively reported in the US VAERS from January 1, 1990, to July 20, 2021.
“A comprehensive study of all cases of myocarditis, pericarditis, or myopericarditis from vaccines passively reported in the United States to the Vaccine Adverse Events System from January 1, 1990, to July 20, 2021, identified 1841 definitive, probable, or possible cases out of 1 048 575 individuals. 84”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The Results (pp. 2–4) report 1,048,575 VAERS individual case safety reports from January 1, 1990, to July 20, 2021, and 1,063 myocarditis, 741 pericarditis, and 37 myopericarditis included reports, totaling 1,841. The case-assessment criteria (p. 9) distinguish definitive, probable, and possible cases. However, the source counts reports, not 1,048,575 distinct individuals. (LLM, conf=0.88)
Experimental — accuracy not yet measured80.5% of myocarditis cases were male and 83.5% aged 12 to 40 years, while 71.2% of pericarditis cases were male and 58.7% aged 12 to 40 years.
“Over this time, 80.5% of cases of myocarditis were male and 83.5% aged 12 to 40 years, while 71.2% of pericarditis cases were male and 58.7% aged 12 to 40 years.”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
The study found 0.38 cases/100,000 individuals for COVID-19 vaccines in the US compared with 1000 to 4000 cases/100,000 individuals for COVID-19.
“The study found 0.38 cases/100 000 individuals for COVID-19 vaccines in the United States compared with 1000 to 4000 cases/100 000 individuals for COVID-19 (Table 1). 84”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [84]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Sagar, S., Liu, P. P., & Cooper, L. T. (2012) · The Lancet · doi:10.1016/s0140-6736(11)60648-x · Cited by 743 · see citing works
Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel
Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., Olsha-Castell, S., Arad, D., Hasin, T., Levi, N., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2109730 · Cited by 599 · see citing works
Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., Broder, K. R., Gee, J., Weintraub, E., Shimabukuro, T., et al. (2021) · MMWR. Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm7027e2 · Cited by 587 · see citing works
Myocarditis after COVID-19 mRNA vaccination: clinical observations and potential mechanisms
Heymans, S., & Cooper, L. T. (2022) · Nature Reviews Cardiology · doi:10.1038/s41569-021-00662-w · Cited by 244 · see citing works
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., et al. (2015) · PLOS ONE · doi:10.1371/journal.pone.0118283 · Cited by 169 · see citing works
Flagged first, then by citations
Research works printed but not linked: 16
- [4]4. Snyder, M.J.; Bepko, J.; White, M. Acute pericarditis: Diagnosis and management. Am. Fam. Physician 2014 , 89 , 553-560. [PubMed]
- [5]5. Tschöpe, C.; Ammirati, E.; Bozkurt, B.; Caforio, A.L.; Cooper, L.T.; Felix, S.B.; Hare, J.M.; Heidecker, B.; Heymans, S.; Hübner, N.; et al. Myocarditis and inflammatory cardiomyopathy: Current evidence and future directions. Nat. Rev. Cardiol. 2021 , 18 , 169-193. [CrossRef] [PubMed]
- [6]6. Patone, M.; Mei, X.W.; Handunnetthi, L.; Dixon, S.; Zaccardi, F.; Shankar-Hari, M.; Watkinson, P.; Khunti, K.; Harnden, A.; Coupland, C.A.C.; et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat. Med. 2022 , 28 , 410-422. [CrossRef] [PubMed]
- [7]7. Olejniczak, M.; Schwartz, M.; Webber, E.; Shaffer, A.; Perry, T.E. Viral Myocarditis-Incidence, Diagnosis and Management. J. Cardiothorac. Vasc. Anesth. 2020 , 34 , 1591-1601. [CrossRef] [PubMed]
- [8]8. Sagar, S.; Liu, P.P.; Cooper, L.T., Jr. Myocarditis. Lancet 2012 , 379 , 738-747. [CrossRef]
- [9]9. Doctor, N.S.; Shah, A.B.; Coplan, N.; Kronzon, I. Acute Pericarditis. Prog. Cardiovasc. Dis. 2017 , 59 , 349-359. [CrossRef] [PubMed]
- [10]10. Fung, G.; Luo, H.; Qiu, Y.; Yang, D.; McManus, B. Myocarditis. Circ. Res. 2016 , 118 , 496-514. [CrossRef] [PubMed]
- [11]11. Imazio, M.; Mayosi, B.M.; Brucato, A.; Markel, G.; Trinchero, R.; Spodick, D.H.; Adler, Y. Triage and management of pericardial effusion. J. Cardiovasc. Med. 2010 , 11 , 928-935. [CrossRef]
- [12]12. Dudley, M.Z.; Halsey, N.A.; Omer, S.B.; Orenstein, W.A.; O'Leary, S.T.; Limaye, R.J.; Salmon, D.A. The state of vaccine safety science: Systematic reviews of the evidence. Lancet Infect. Dis. 2020 , 20 , e80-e89. [CrossRef]
- [13]13. Su, J.R.; McNeil, M.M.; Welsh, K.J.; Marquez, P.L.; Ng, C.; Yan, M.; Cano, M.V. Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018. Vaccine 2021 , 39 , 839-845. [CrossRef] [PubMed]
- [14]14. Witberg, G.; Barda, N.; Hoss, S.; Richter, I.; Wiessman, M.; Aviv, Y.; Grinberg, T.; Auster, O.; Dagan, N.; Balicer, R.D.; et al. Myocarditis after COVID-19 Vaccination in a Large Health Care Organization. N. Engl. J. Med. 2021 , 385 , 2132-2139. [CrossRef] [PubMed]
- [18]18. Montgomery, J.; Ryan, M.; Engler, R.; Hoffman, D.; McClenathan, B.; Collins, L.; Loran, D.; Hrncir, D.; Herring, K.; Platzer, M.; et al. Myocarditis Following Immunization with mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. 2021 , 6 , 1202-1206. [CrossRef] [PubMed]
- [19]19. Hajjo, R.; Sabbah, D.A.; Bardaweel, S.K.; Tropsha, A. Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients. Vaccines 2021 , 9 , 1186. [CrossRef] [PubMed]
- [20]20. Viveiros, A.; Rasmuson, J.; Vu, J.; Mulvagh, S.L.; Yip, C.Y.Y.; Norris, C.M.; Oudit, G.Y. Sex differences in COVID-19: Candidate pathways, genetics of ACE2, and sex hormones. Am. J. Physiol. Heart Circ. Physiol. 2021 , 320 , H296-H304. [CrossRef] [PubMed]
- [21]21. Keinath, K.; Church, T.; Kurth, B.; Hulten, E. Myocarditis secondary to smallpox vaccination. BMJ Case Rep. 2018 , 22 , bcr-2017. [CrossRef] [PubMed]
- [22]22. Cassimatis, D.C.; Atwood, J.E.; Engler, R.M.; Linz, P.E.; Grabenstein, J.D.; Vernalis, M.N. Smallpox vaccination and myopericarditis: Aclinical review. J. Am. Coll. Cardiol. 2004 , 43 , 1503-1510. [CrossRef] [PubMed]
Cited by
Sorted by citations
COVID-19, Myocarditis and Pericarditis
Fairweather, D., Beetler, D. J., Di Florio, D. N., Musigk, N., Heidecker, B., & Cooper, L. T. (2023) · Circulation Research · doi:10.1161/circresaha.123.321878 · Cited by 181 · see citing works
- Authors
- Rafaniello, C., Gaio, M., Zinzi, A., Sullo, M. G., Liguori, V., Ferraro, M., Petronzelli, F., Felicetti, P., Marchione, P., Marra, A. R., Rossi, F., De Angelis, A., & Capuano, A.
- Affiliations
- University of Campania "Luigi Vanvitelli" (IT)
- Italian Medicines Agency (IT)
- Section of Pharmacology “L. Donatelli”, Department of Experimental Medicine, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
- Corresponding author
- Zinzi, Alessia
- ORCID
- Venue
- Pharmaceuticals
- Publisher
- MDPI AG
- Published
- 2022-04-25
- Volume
- 15
- Issue
- 5
- Pages
- 525
- ISSN
- 1424-8247 (ISSN-L)
- PMC
- PMC9145505
- OpenAlex
- W4224944770
- Cited by
- 16
- References
- 5
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 6 · 2023: 2 · 2022: 1
- FWCI
- 2.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Pharmaceuticals (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- myocarditis, pericarditis, COVID-19 mRNA vaccine, vaccine adverse events, COVID-19 pandemic, smallpox vaccine, VAERS, relative risk, young men
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
