Myocarditis after Covid-19 Vaccination in a Large Health Care Organization

Witberg, Guy; Barda, Noam; Hoss, Sara; Richter, Ilan; Wiessman, Maya; Aviv, Yaron; Grinberg, Tzlil; Auster, Oren; Dagan, Noa; Balicer, Ran D.; Kornowski, Ran

doi:10.1056/nejmoa2110737

Cited by 540 publications

(625 citation statements)

References 5 publications

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“…We observed no significant increase in EHR reporting of severe adverse events after the 3 rd dose compared with after the 2 nd dose, with incidence comparable with previous literature. 16,17 The observed increase in adverse events compared with earlier doses could be due to a stronger response elicited by the 3 rd dose, comparable to what was observed for the 2 nd dose compared with the 1 st dose. 1,2,33 Further studies are needed to explore whether the 3 rd vaccine dose does indeed induce a stronger immune response.…”

Section: Discussionsupporting

confidence: 64%

“…Extensive research has shown that the standard 2-dose regimen of mRNA-based COVID-19 vaccines is relatively safe. Although severe adverse events such as anaphylaxis, 15 myocarditis, 16,17 and blood clotting, [18][19][20][21][22] have been reported after COVID-19 vaccination, these are rare and the benefit of vaccination is deemed to outweigh the potential risks. The most common adverse reactions occur immediately post vaccination 23 and are relatively mild, including headache, fatigue, pains, low-grade fever, and nausea.…”

Section: Introductionmentioning

confidence: 99%

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Three doses of COVID-19 mRNA vaccination are safe based on adverse events reported in electronic health records

Niesen

Pawlowski

O’Horo

et al. 2021

Preprint

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Recent reports on waning of COVID-19 vaccine induced immunity have led to the approval and roll-out of additional dose and booster vaccinations. At risk individuals are receiving additional vaccine dose(s), in addition to the regimen that was tested in clinical trials. The risks and the adverse event profiles associated with these additional vaccine doses are currently not well understood. Here, we performed a retrospective study analyzing vaccine-associated adverse events using electronic health records (EHRs) of individuals that have received three doses of mRNA-based COVID-19 vaccines (n = 47,999). By comparing symptoms reported in 2-week time periods after each vaccine dose and in a 2-week period before the 1st vaccine dose, we assessed the risk associated with 3rd dose vaccination, for both BNT162b2 and mRNA-1273. Reporting of severe adverse events remained low after the 3rd vaccine dose, with rates of pericarditis (0.01%, 0%-0.02% 95% CI), anaphylaxis (0.00%, 0%-0.01% 95% CI), myocarditis (0.00%, 0%-0.01% 95% CI), and cerebral venous sinus thrombosis (no cases), consistent with earlier studies. Significantly more individuals (p-value < 0.05) report low-severity adverse events after their 3rd dose compared with after their 2nd dose, including fatigue (4.92% after 3rd dose vs 3.47% after 2nd dose), lymphadenopathy (2.89% vs 2.07%), nausea (2.62% vs 2.04%), headache (2.47% vs 2.07%), arthralgia (2.12% vs 1.70%), myalgia (1.99% vs 1.63%), diarrhea (1.70% vs 1.24%), fever (1.11% vs 0.81%), vomiting (1.10% vs 0.80%), and chills (0.47% vs 0.36%). Our results show that although 3rd dose vaccination against SARS-CoV-2 infection led to increased reporting of low-severity adverse events, risk of severe adverse events remained comparable to the standard 2-dose regime. This study provides support for the safety of 3rd vaccination doses of individuals that are at high-risk of severe COVID-19 and breakthrough infection.

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Section: Discussionsupporting

confidence: 64%

Section: Introductionmentioning

confidence: 99%

Three doses of COVID-19 mRNA vaccination are safe based on adverse events reported in electronic health records

Niesen

Pawlowski

O’Horo

et al. 2021

Preprint

View full text Add to dashboard Cite

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“…Finally, the rates of myocarditis in our study can be compared with those in the Clalit Health Services database in the study by Witberg et al, 9 as now reported in the Journal . That study showed a somewhat lower incidence of myocarditis, possibly because of the different methods that were used.…”

Section: Discussionmentioning

confidence: 61%

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

Mevorach¹,

et al. 2021

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Background Approximately 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. Methods We 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. Results Among 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. Conclusions The 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.

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“…Another study reported an incidence of 10.7 cases per 100 000 persons in males aged 16-29 years. 95 Of these patients, approximately 6% required intensive care admission. 96 However, most recovered without sequelae (86% had resolution of symptoms after mean duration of 35 days).…”

Section: Risk Of Adverse Effectsmentioning

confidence: 99%

Should children be vaccinated against COVID-19?

et al. 2021

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Whether all children under 12 years of age should be vaccinated against COVID-19 remains an ongoing debate. The relatively low risk posed by acute COVID-19 in children, and uncertainty about the relative harms from vaccination and disease mean that the balance of risk and benefit of vaccination in this age group is more complex. One of the key arguments for vaccinating healthy children is to protect them from long-term consequences. Other considerations include population-level factors, such as reducing community transmission, vaccine supply, cost, and the avoidance of quarantine, school closures and other lockdown measures. The emergence of new variants of concern necessitates continual re-evaluation of the risks and benefits. In this review, we do not argue for or against vaccinating children against COVID-19 but rather outline the points to consider and highlight the complexity of policy decisions on COVID-19 vaccination in this age group.

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Myocarditis after Covid-19 Vaccination in a Large Health Care Organization

Cited by 540 publications

References 5 publications

Three doses of COVID-19 mRNA vaccination are safe based on adverse events reported in electronic health records

Three doses of COVID-19 mRNA vaccination are safe based on adverse events reported in electronic health records

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

Should children be vaccinated against COVID-19?

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