Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children

• Type of Material: Article
• Authors: Matthew MD Elias, The Children's Hospital of Philadelphia; Dongngan T Truong, The University of Utah; Matthew Oster, Emory University; Felicia L Trachtenberg, HealthCore Incorporated Wilmington; Xiangyu Mu, HealthCore Incorporated Wilmington; Pei-Ni Jone, The Children's Hospital, Aurora; Elizabeth C Mitchell, Cohen Children’s Medical Center; Kirsten B Dummer, Department of Pediatrics; Kristen S Sexson Tejtel, Texas Children's Hospital Houston; Onyekachukwu Osakwe, University of Mississippi Medical Center; Deepika Thacker, Alfred I. duPont Hospital for Children; Jennifer A Su, Children's Hospital Los Angeles; Tamara T Bradford, Children's Hospital of New Orleans; Kristin M Burns, National Institutes of Health; Jay M Campbell, Duke University Medical Center; Thomas J Connors, Vagelos College of Physicians and Surgeons; Laura D'Addese, Joe DiMaggio Children's Hospital; Daniel Forsha, Children's Mercy Kansas City; Olivia H Frosch, C.S. Mott Children's Hospital; Therese M Giglia, The Children's Hospital of Philadelphia; Lauren R Goodell, Ann & Robert H. Lurie Children's Hospital of Chicago; Stephanie S Handler, Medical College of Wisconsin; Keren Hasbani, The University of Texas at Austin; Camden Hebson, Emory University; Anita Krishnan, Children's National Hospital; Sean M Lang, Cincinnati Children's Hospital Medical Center; Brian W McCrindle, Hospital for Sick Children University of Toronto; Kimberly E McHugh, Medical University of South Carolina; Lerraughn M Morgan, Valley Children's Healthcare; Mark R Payne, Indiana University School of Medicine; Arash Sabati, Phoenix Children's Hospital; Eyal Sagiv, University of Washington School of Medicine; Yamuna Sanil, Central Michigan University; Faridis Serrano, Texas Children's Hospital Houston; Jane W Newburger, Children's Hospital Boston; Audrey Dionne, Children's Hospital Boston
• Language: English
• Date: 2023-01-03
• Publisher: American Medical Association
• Publication Version: Final Published Version
• Copyright Statement: 2023 Elias MD et al. JAMA Network Open.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1001/jamanetworkopen.2022.48987
• Title of Journal or Parent Work: JAMA network open
• Volume: 6
• Issue: 1
• Start Page: e2248987
• End Page: e2248987
• Grant/Funding Information: The MUSIC study was supported by grants HL135680, HL135685, HL135683, HL135689, HL135646, HL135665, HL135678, HL135682, HL135666, HL135691, and HL068270 from the NHLBI, NIH.
• Keywords: COVID-19 Vaccines; Humans; BNT162 Vaccine; Connective Tissue Diseases; Female; COVID-19; United States; Male; Child, Preschool; Cross-Sectional Studies; Vaccination; Child
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

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 χ2 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.