• Guy Witberg, Noam Barda, Sara Hoss, Ilan Richter, Maya Wiessman, Yaron Aviv, Tzlil Grinberg, Oren Auster, Noa Dagan, Ran D Balicer, and Ran Kornowski.
• From the Cardiology Department, Rabin Medical Center, Beilinson Hospital, Petah Tikva (G.W., S.H., I.R., M.W., Y.A., T.G., R.K.), the Faculty of Medicine, Tel Aviv University (G.W., S.H., I.R., M.W., Y.A., T.G., R.K.), and the Innovation Division, Clalit Research Institute, Clalit Health Services (N.B., O.A., N.D., R.D.B.), Tel Aviv, and the Department of Software and Information Systems Engineering (N.B., N.D.) and the School of Public Health, Faculty of Health Sciences (R.D.B.), Ben Gurion University, Be'er Sheva - all in Israel; and the Department of Biomedical Informatics, Harvard Medical School (N.B., N.D.), and the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute (N.B., N.D., R.D.B.) - both in Boston.
• N. Engl. J. Med. 2021 Dec 2; 385 (23): 2132-2139.

BackgroundReports have suggested an association between the development of myocarditis and the receipt of messenger RNA (mRNA) vaccines against coronavirus disease 2019 (Covid-19), but the frequency and severity of myocarditis after vaccination have not been extensively explored.MethodsWe searched the database of Clalit Health Services, the largest health care organization (HCO) in Israel, for diagnoses of myocarditis in patients who had received at least one dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech). The diagnosis of myocarditis was adjudicated by cardiologists using the case definition used by the Centers for Disease Control and Prevention. We abstracted the presentation, clinical course, and outcome from the patient's electronic health record. We performed a Kaplan-Meier analysis of the incidence of myocarditis up to 42 days after the first vaccine dose.ResultsAmong more than 2.5 million vaccinated HCO members who were 16 years of age or older, 54 cases met the criteria for myocarditis. The estimated incidence per 100,000 persons who had received at least one dose of vaccine was 2.13 cases (95% confidence interval [CI], 1.56 to 2.70). The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years. A total of 76% of cases of myocarditis were described as mild and 22% as intermediate; 1 case was associated with cardiogenic shock. After a median follow-up of 83 days after the onset of myocarditis, 1 patient had been readmitted to the hospital, and 1 had died of an unknown cause after discharge. Of 14 patients who had left ventricular dysfunction on echocardiography during admission, 10 still had such dysfunction at the time of hospital discharge. Of these patients, 5 underwent subsequent testing that revealed normal heart function.ConclusionsAmong patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.).Copyright © 2021 Massachusetts Medical Society.

31 keywords...

hide…