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Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children.
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.
  • Elias MD; Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
  • Truong DT; Division of Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City.
  • Oster ME; Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia.
  • Trachtenberg FL; HealthCore Inc, Newton, Massachusetts.
  • Mu X; HealthCore Inc, Newton, Massachusetts.
  • Jone PN; Department of Pediatrics, Pediatric Cardiology, Children's Hospital Colorado, University of Colorado, Anschutz Medical Campus, Aurora.
  • Mitchell EC; Cohen Children's Medical Center, Northwell Health, New Hyde Park, New York.
  • Dummer KB; Division of Pediatric Cardiology, Department of Pediatrics, University of California, San Diego, School of Medicine and Rady Children's Hospital, San Diego, California.
  • Sexson Tejtel SK; Baylor College of Medicine, Texas Children's Hospital, Houston.
  • Osakwe O; University of Mississippi Medical Center, Jackson.
  • Thacker D; Nemours Children's Hospital, Wilmington, Delaware.
  • Su JA; Division of Cardiology, Children's Hospital Los Angeles, Los Angeles, California.
  • Bradford TT; Children's Hospital of New Orleans, New Orleans, Louisiana.
  • Burns KM; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
  • Campbell MJ; Division of Pediatric Cardiology, Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
  • Connors TJ; Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons and New York-Presbyterian Morgan Stanley Children's Hospital, New York, New York.
  • D'Addese L; The Heart Institute, Joe DiMaggio Children's Hospital, Hollywood, Florida.
  • Forsha D; Ward Family Heart Center, Children's Mercy Kansas City, Kansas City, Missouri.
  • Frosch OH; Division of Pediatric Cardiology, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor.
  • Giglia TM; Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
  • Goodell LR; Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.
  • Handler SS; Department of Pediatrics, Division of Pediatric Cardiology, Medical College of Wisconsin, Milwaukee.
  • Hasbani K; Dell Children's Medical Center, The University of Texas at Austin.
  • Hebson C; Department of Pediatrics, Division of Pediatric Cardiology, University of Alabama at Birmingham, Birmingham.
  • Krishnan A; Division of Cardiology, Children's National Hospital, Washington, DC.
  • Lang SM; The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
  • McCrindle BW; Department of Pediatrics, University of Toronto, Labatt Family Heart Centre, The Hospital for Sick Children, Toronto, Canada.
  • McHugh KE; Department of Pediatrics, Medical University of South Carolina, Charleston.
  • Morgan LM; Valley Children's Healthcare and Hospital, Madera, California.
  • Payne RM; Riley Hospital for Children, Indiana University School of Medicine, Indianapolis.
  • Sabati A; Center for Heart Care, Phoenix Children's Hospital, Phoenix, Arizona.
  • Sagiv E; Division of Pediatric Cardiology, Seattle Children's Hospital and the University of Washington School of Medicine, Seattle, Washington.
  • Sanil Y; Division of Pediatric Cardiology, Department of Pediatrics, Children's Hospital of Michigan, Central Michigan University, Detroit, Michigan.
  • Serrano F; Baylor College of Medicine, Texas Children's Hospital, Houston.
  • Newburger JW; Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.
  • Dionne A; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
JAMA Netw Open ; 6(1): e2248987, 2023 01 03.
Article in English | MEDLINE | ID: covidwho-2172237
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Connective Tissue Diseases / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Child / Child, preschool / Female / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2023 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Connective Tissue Diseases / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Child / Child, preschool / Female / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2023 Document Type: Article