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Elias, Matthew D; Truong, Dongngan T; Oster, Matthew E; Trachtenberg, Felicia L; Mu, Xiangyu; Jone, Pei-Ni; Mitchell, Elizabeth C; Dummer, Kirsten B; Sexson Tejtel, S Kristen; Osakwe, Onyekachukwu; Thacker, Deepika; Su, Jennifer A; Bradford, Tamara T; Burns, Kristin M; Campbell, M Jay; Connors, Thomas J; D'Addese, Laura; Forsha, Daniel; Frosch, Olivia H; Giglia, Therese M; Goodell, Lauren R; Handler, Stephanie S; Hasbani, Keren; Hebson, Camden; Krishnan, Anita; Lang, Sean M; McCrindle, Brian W; McHugh, Kimberly E; Morgan, Lerraughn M; Payne, R Mark; Sabati, Arash; Sagiv, Eyal; Sanil, Yamuna; Serrano, Faridis; Newburger, Jane W; Dionne, Audrey
JAMA network open, 01/2023, Volume: 6, Issue: 1Journal Article
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. To describe adverse reactions following COVID-19 vaccination in patients with a history of MIS-C. 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. COVID-19 vaccination after MIS-C diagnosis. The main outcome was adverse reactions following COVID-19 vaccination. Comparisons were made using the Wilcoxon rank sum test for continuous variables and the χ2 or Fisher exact test for categorical variables. 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. 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.
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