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Multicenter Study
. 2023 Jan 3;6(1):e2248987.
doi: 10.1001/jamanetworkopen.2022.48987.

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

Matthew D Elias  1 , Dongngan T Truong  2 , Matthew E Oster  3 , Felicia L Trachtenberg  4 , Xiangyu Mu  4 , Pei-Ni Jone  5 , Elizabeth C Mitchell  6 , Kirsten B Dummer  7 , S Kristen Sexson Tejtel  8 , Onyekachukwu Osakwe  9 , Deepika Thacker  10 , Jennifer A Su  11 , Tamara T Bradford  12 , Kristin M Burns  13 , M Jay Campbell  14 , Thomas J Connors  15 , Laura D'Addese  16 , Daniel Forsha  17 , Olivia H Frosch  18 , Therese M Giglia  1 , Lauren R Goodell  19 , Stephanie S Handler  20 , Keren Hasbani  21 , Camden Hebson  22 , Anita Krishnan  23 , Sean M Lang  24 , Brian W McCrindle  25 , Kimberly E McHugh  26 , Lerraughn M Morgan  27 , R Mark Payne  28 , Arash Sabati  29 , Eyal Sagiv  30 , Yamuna Sanil  31 , Faridis Serrano  8 , Jane W Newburger  32   33 , Audrey Dionne  32   33 ; Pediatric Heart Network MUSIC Study Investigators
Collaborators, Affiliations
Multicenter Study

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

Matthew D Elias et al. JAMA Netw Open. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Elias reported receiving grants from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) during the conduct of the study. Dr Truong reported receiving grants from the NHLBI, NIH during the conduct of the study. Dr Oster reported receiving grants from the US Department of Health & Human Services (HHS) and the NHLBI, NIH during the conduct of the study. Dr Dummer reported receiving grants from the NIH, Pediatric Heart Network (PHN), and NIH Longitudinal Study for Multisystem Inflammatory Syndrome Therapies in Children during the conduct of the study. Dr Osakwe reported receiving grants from the HHS, NIH, and NHLBI, NIH during the conduct of the study. Dr Bradford reported receiving grants from the Children’s Hospital of New Orleans; NHLBI, NIH; and PHN during the conduct of the study. Dr Campbell reported receiving grants from the Centers for Disease Control and Prevention and serving on the Clinical Immunization Safety Assessment during the conduct of the study and being a consultant for and receiving personal fees from Longeveron Inc outside the submitted work. Dr Connors reported receiving grants from the NIH outside the submitted work. Dr Goodell reported receiving grants from the PHN during the conduct of the study. Dr Hasbani reported receiving grants from the NHLBI, NIH during the conduct of the study. Dr Krishnan reported receiving a grant from the NIH to Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC) during the conduct of the study. Dr McCrindle reported consulting for and receiving personal fees from Janssen, Chiesi, Esperion, Ultragenyx, and Amryt Pharma outside the submitted work. Dr Morgan reported receiving grants from the NHLBI, NIH during the conduct of the study. Dr Sanil reported receiving grants from the NHLBI, NIH during the conduct of the study. Dr Newburger reported receiving grants and personal fees from Pfizer outside the submitted work and receiving grants from the NHLBI, NIH and the PHN during the conduct of the study. Dr Dionne reported receiving grants from the NHLBI, NIH during the conduct of the study and receiving grants from Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. COVID-19 Vaccination Adverse Reaction Summary Among 185 Patients With a History of Multisystem Inflammatory Syndrome in Children (MIS-C)
See this image and copyright information in PMC

References

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