Elias MD, Truong DT, Oster ME, Trachtenberg FL, Mu X, Jone PN, Mitchell EC, Dummer KB, Sexson Tejtel SK, Osakwe O, Thacker D, Su JA, Bradford TT, Burns KM, Campbell MJ, Connors TJ, D'Addese L, Forsha D, Frosch OH, Giglia TM, Goodell LR, Handler SS, Hasbani K, Hebson C, Krishnan A, Lang SM, McCrindle BW, McHugh KE, Morgan LM, Payne RM, Sabati A, Sagiv E, Sanil Y, Serrano F, Newburger JW, Dionne A
IMPORTANCE: Data are limited regarding adverse reactions after COVID-19 vaccination in patients with a history of multisystem inflammatory syndrome in children (MIS-C). The lack of vaccine safety data in this unique population may cause hesitancy and concern for many families and health care professionals. OBJECTIVE: To describe adverse reactions following COVID-19 vaccination in patients with a history of MIS-C. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter cross-sectional study including 22 North American centers participating in a National Heart, Lung, and Blood Institute, National Institutes of Health-sponsored study, Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC), patients with a prior diagnosis of MIS-C who were eligible for COVID-19 vaccination (age >/=5 years; >/=90 days after MIS-C diagnosis) were surveyed between December 13, 2021, and February 18, 2022, regarding COVID-19 vaccination status and adverse reactions. EXPOSURES: COVID-19 vaccination after MIS-C diagnosis. MAIN OUTCOMES AND MEASURES: The main outcome was adverse reactions following COVID-19 vaccination. Comparisons were made using the Wilcoxon rank sum test for continuous variables and the chi2 or Fisher exact test for categorical variables. RESULTS: Of 385 vaccine-eligible patients who were surveyed, 185 (48.1%) received at least 1 vaccine dose; 136 of the vaccinated patients (73.5%) were male, and the median age was 12.2 years (IQR, 9.5-14.7 years). Among vaccinated patients, 1 (0.5%) identified as American Indian/Alaska Native, non-Hispanic; 9 (4.9%) as Asian, non-Hispanic; 45 (24.3%) as Black, non-Hispanic; 59 (31.9%) as Hispanic or Latino; 53 (28.6%) as White, non-Hispanic; 2 (1.1%) as multiracial, non-Hispanic; and 2 (1.1%) as other, non-Hispanic; 14 (7.6%) had unknown or undeclared race and ethnicity. The median time from MIS-C diagnosis to first vaccine dose was 9.0 months (IQR, 5.1-11.9 months); 31 patients (16.8%) received 1 dose, 142 (76.8%) received 2 doses, and 12 (6.5%) received 3 doses. Almost all patients received the BNT162b2 vaccine (347 of 351 vaccine doses [98.9%]). Minor adverse reactions were observed in 90 patients (48.6%) and were most often arm soreness (62 patients [33.5%]) and/or fatigue (32 [17.3%]). In 32 patients (17.3%), adverse reactions were treated with medications, most commonly acetaminophen (21 patients [11.4%]) or ibuprofen (11 [5.9%]). Four patients (2.2%) sought medical evaluation, but none required testing or hospitalization. There were no patients with any serious adverse events, including myocarditis or recurrence of MIS-C. CONCLUSIONS AND RELEVANCE: In this cross-sectional study of patients with a history of MIS-C, no serious adverse events were reported after COVID-19 vaccination. These findings suggest that the safety profile of COVID-19 vaccination administered at least 90 days following MIS-C diagnosis appears to be similar to that in the general population.
04/01/2023
36595296
JAMA network open (
IF: 13.353 /
Quartile: )
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