Dataset Information

Myocarditis after BNT162b2 and mRNA-1273 COVID-19 vaccination: A report of 7 cases.

ABSTRACT:

Background and objectives

According to some reports, there is a link between the development of myocarditis and the administration of messenger RNA (mRNA) vaccines against coronavirus disease (COVID-19). Here, we report seven cases that developed myocarditis after receiving a second dose of mRNA COVID-19 vaccine.

Methods

This is a multi-center case series study. In this study, we present 7 patients diagnosed with myocarditis following BNT162b2 and mRNA-1273 COVID-19 vaccinations on March 7, 2021, and March 3, 2022.

Results

All seven patients were males and hemodynamically stable. The median age was 24.5 years, ranging from 16 to 36 years old. All patients received the second dose of a messenger RNA (mRNA) vaccine between one and four days before being admitted to the hospital (5 received BNT162b2 [Pfizer-BioNTech] and 2 received mRNA-1273 [Moderna]). The electrocardiograms of all seven patients were abnormal, and their troponin levels were elevated. Moreover, all patients were treated with colchicine and NSAIDs. The average length of stay in the hospital was 2.4 days, and all of the patients' symptoms had resolved by the time they were discharged.

Conclusion

The results of the current study raise the possibility of an association between BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna] COVID-19 vaccination and myocarditis.

SUBMITTER: Ahmed SK

PROVIDER: S-EPMC9021031 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Myocarditis after BNT162b2 and mRNA-1273 COVID-19 vaccination: A report of 7 cases.

Ahmed Sirwan Khalid SK

Annals of medicine and surgery (2012) 20220421

<h4>Background and objectives</h4>According to some reports, there is a link between the development of myocarditis and the administration of messenger RNA (mRNA) vaccines against coronavirus disease (COVID-19). Here, we report seven cases that developed myocarditis after receiving a second dose of mRNA COVID-19 vaccine.<h4>Methods</h4>This is a multi-center case series study. In this study, we present 7 patients diagnosed with myocarditis following BNT162b2 and mRNA-1273 COVID-19 vaccinations o ...[more]

PMID: 35479661

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Project description:BackgroundEvidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population.MethodsMembers 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination.ResultsFrom December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7-64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54).ConclusionsBoth vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.

Project description:BackgroundApproximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance.MethodsWe retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons.ResultsAmong 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.ConclusionsThe incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

Dataset Information

Myocarditis after BNT162b2 and mRNA-1273 COVID-19 vaccination: A report of 7 cases.

Background and objectives

Methods

Results

Conclusion

Publications

Myocarditis after BNT162b2 and mRNA-1273 COVID-19 vaccination: A report of 7 cases.

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