Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children
Authors: 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 ,   Pediatric Heart Network MUSIC Study Investigators, Pearson Gail , Pemberton Victoria , Egerson D’Andrea , Mahony Lynn , Miller Julie , Hayes Kerri , Crosby-Thompson Allison , Amarnath Ayesha , Ambrosoli James , Artis Cassandra , Rubio Kay , Kinhikar Chitra , Marshall Amanda , Mbiydzenyuy Devine , Kazlova Valentina , Hu Chenwei , Eyob Lozan , Slayton Beverly , DiStefano Lauren , Honig Jami , Bowie Tiffany , Nero Rob , Birmingham Emily , Rowe Robin , Joyce Melissa , Gallagher Cole , Bowman Djenawa , Zhang Mo , Mooney Alissa , Dragulescu Andreea , Lam Christopher , Yeung Rae , Gamulka Beth , Bainton Jessica , Rolland Martha , Walter Patti , Mahanta Simran , Giorgio Thomas , Khan Numaira , Baker Annette , Buckley Lisa Jean , Jones Jessica , Watson LaTina , Clarke Anna , Leek Tor-Samuel-Aleer , Orav Gwendolyn , Morrison Tonia , Lupton Katherine , Sylvester Donna , Albizem Dana , Lanzilotta Kristin , Marks Grace , Johnson Madison , Bickford Megan , Lambert Linda , Fagatele Lilly , Curless Andrea , Russell Mark , Doman Tammy , Almaguer Marisa , Dugan Lauryn , Rathge Kathleen , Seibert Elizabeth , Stumpf Mary , Howell Jennifer , Patel Jyoti , Mitscher Gloria , Burnett Melissa , Sanders-Lewis Kolby , Evans Brooke , Mahle William T. , Kochilas Lazaros , Rudow Madison , Gentry Susie , Le Kristie , Taylor Caitlen , Shekerdemian Lara , Moussi Elias , Pena Sandra , Pignatelli Ricardo , Garuba Olukayode , Liu Asela , Anderson Brett , Sanchez Chantal , Martyrosyan Karen , Szmuszkovicz Jacqueline R. , Cheng Andrew L. , Mohandas Sindhu , Votava-Smith Jodie K. , Wang Shuo , Wong Pierre C. , Sharma Kavita , Martinez Maria , Mohazabnia Parvin , Rojas Wendy , Block Joseph , Cole Regina , Maldonado Jennifer , Srivastava Shubhika , Prospero Carol , Zadokar Varsha , Williams Ed , Carr Michael , Van't Hof Kathleen , Sullivan Colleen , Portman Michael A. , Kajimoto Hidemi , Nair Deepthi G. , Beckley Mikayla A. , Pancheri Joan , Crane Katheryn , Harahsheh Ashraf , Berul Charles , Olivieri Laura , Haverty Mitchell , Fetch Alix , Schott Christina , Litt Sarah , Nelson Jennifer , Hite Michelle , Glassmeyer Isabel , Nowlen Todd , Herzberg Ashley , Stack Samantha , Porche Jade , Park Susan , Johnson Amy , Shakti Divya , Parnell Aimee S. , Weiland Michael D. , Parker Phenique , Kertis Jeffrey A. , Hobbs Charlotte V. , Howard Candace M. , Savadkar Shivraj , Worrell Aren E. , Barr Madelyn R. , Williams Heather , Gordy David , Vemula Preeti , White Zachary , Morato Jemylle Grace S. , Tyler Sandra , Hock Krissie , Sykes Michelle , Owada Carl , Lemus Rangel Mayra , Macias Isaura , Singh Gautham , Aggarwal Sanjeev , Williams-Farr Charmaine , Sullivan Nancy , Almasnaah Aiman , Undyala Vishnu , Hannah Brian , McCall Mary , Strelow Jacob , Downey Rachel , Shaffer Ken , Castleberry Chesney , Pomeroy Lisa , Amsellem Rachel , Shamailova Olga , Johnston Marla , Muniz Juan Carlos , Chang Moya , Shea Ryan , Davis Miriam , Chrisant Maryanne , Katz Danielle , Barton Norma , Alaby Doris , Smith Paulette , Friedman Kevin , Sperotto Francesca , Marcus Ed , Ferreira Raquel , McGeoghegan Patrick , Taylor Michael , Germann Joshua , Powell Andrew , Mackie Andrew , Gobburu Jogarao , Hunsberger Sally , McQuillen Patrick , Spaeder Michael , Atkins Dianne , Broberg Craig , Driscoll David J. , Evans Frank , Hunsberger Sally A. , Johnson Liza-Marie , Knight Thomas J. , Lipkin Paul , Saul J. Philip 
Published: January 2023

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.