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Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study.

Publication ,  Journal Article
Kracalik, I; Oster, ME; Broder, KR; Cortese, MM; Glover, M; Shields, K; Creech, CB; Romanson, B; Novosad, S; Soslow, J; Walter, EB; Marquez, P ...
Published in: Lancet Child Adolesc Health
November 2022

BACKGROUND: Data on medium-term outcomes in indivduals with myocarditis after mRNA COVID-19 vaccination are scarce. We aimed to assess clinical outcomes and quality of life at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults. METHODS: In this follow-up surveillance study, we conducted surveys in US individuals aged 12-29 years with myocarditis after mRNA COVID-19 vaccination, for whom a report had been filed to the Vaccine Adverse Event Reporting System between Jan 12 and Nov 5, 2021. A two-component survey was administered, one component to patients (or parents or guardians) and one component to health-care providers, to assess patient outcomes at least 90 days since myocarditis onset. Data collected were recovery status, cardiac testing, and functional status, and EuroQol health-related quality-of-life measures (dichotomised as no problems or any problems), and a weighted quality-of-life measure, ranging from 0 to 1 (full health). The EuroQol results were compared with published results in US populations (aged 18-24 years) from before and early on in the COVID-19 pandemic. FINDINGS: Between Aug 24, 2021, and Jan 12, 2022, we collected data for 519 (62%) of 836 eligible patients who were at least 90 days post-myocarditis onset: 126 patients via patient survey only, 162 patients via health-care provider survey only, and 231 patients via both surveys. Median patient age was 17 years (IQR 15-22); 457 (88%) patients were male and 61 (12%) were female. 320 (81%) of 393 patients with a health-care provider assessment were considered recovered from myocarditis by their health-care provider, although at the last health-care provider follow-up, 104 (26%) of 393 patients were prescribed daily medication related to myocarditis. Of 249 individuals who completed the quality-of-life portion of the patient survey, four (2%) reported problems with self-care, 13 (5%) with mobility, 49 (20%) with performing usual activities, 74 (30%) with pain, and 114 (46%) with depression. Mean weighted quality-of-life measure (0·91 [SD 0·13]) was similar to a pre-pandemic US population value (0·92 [0·13]) and significantly higher than an early pandemic US population value (0·75 [0·28]; p<0·0001). Most patients had improvements in cardiac diagnostic marker and testing data at follow-up, including normal or back-to-baseline troponin concentrations (181 [91%] of 200 patients with available data), echocardiograms (262 [94%] of 279 patients), electrocardiograms (240 [77%] of 311 patients), exercise stress testing (94 [90%] of 104 patients), and ambulatory rhythm monitoring (86 [90%] of 96 patients). An abnormality was noted among 81 (54%) of 151 patients with follow-up cardiac MRI; however, evidence of myocarditis suggested by the presence of both late gadolinium enhancement and oedema on cardiac MRI was uncommon (20 [13%] of 151 patients). At follow-up, most patients were cleared for all physical activity (268 [68%] of 393 patients). INTERPRETATION: After at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination, most individuals in our cohort were considered recovered by health-care providers, and quality of life measures were comparable to those in pre-pandemic and early pandemic populations of a similar age. These findings might not be generalisable given the small sample size and further follow-up is needed for the subset of patients with atypical test results or not considered recovered. FUNDING: US Centers for Disease Control and Prevention.

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Published In

Lancet Child Adolesc Health

DOI

EISSN

2352-4650

Publication Date

November 2022

Volume

6

Issue

11

Start / End Page

788 / 798

Location

England

Related Subject Headings

  • Young Adult
  • Vaccination
  • United States
  • Troponin
  • RNA, Messenger
  • Quality of Life
  • Pandemics
  • Myocarditis
  • Male
  • Humans
 

Citation

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Kracalik, I., Oster, M. E., Broder, K. R., Cortese, M. M., Glover, M., Shields, K., … Myocarditis Outcomes After mRNA COVID-19 Vaccination Investigators and the CDC COVID-19 Response Team, . (2022). Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. Lancet Child Adolesc Health, 6(11), 788–798. https://doi.org/10.1016/S2352-4642(22)00244-9
Kracalik, Ian, Matthew E. Oster, Karen R. Broder, Margaret M. Cortese, Maleeka Glover, Karen Shields, C Buddy Creech, et al. “Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study.Lancet Child Adolesc Health 6, no. 11 (November 2022): 788–98. https://doi.org/10.1016/S2352-4642(22)00244-9.
Kracalik I, Oster ME, Broder KR, Cortese MM, Glover M, Shields K, et al. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. Lancet Child Adolesc Health. 2022 Nov;6(11):788–98.
Kracalik, Ian, et al. “Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study.Lancet Child Adolesc Health, vol. 6, no. 11, Nov. 2022, pp. 788–98. Pubmed, doi:10.1016/S2352-4642(22)00244-9.
Kracalik I, Oster ME, Broder KR, Cortese MM, Glover M, Shields K, Creech CB, Romanson B, Novosad S, Soslow J, Walter EB, Marquez P, Dendy JM, Woo J, Valderrama AL, Ramirez-Cardenas A, Assefa A, Campbell MJ, Su JR, Magill SS, Shay DK, Shimabukuro TT, Basavaraju SV, Myocarditis Outcomes After mRNA COVID-19 Vaccination Investigators and the CDC COVID-19 Response Team. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. Lancet Child Adolesc Health. 2022 Nov;6(11):788–798.

Published In

Lancet Child Adolesc Health

DOI

EISSN

2352-4650

Publication Date

November 2022

Volume

6

Issue

11

Start / End Page

788 / 798

Location

England

Related Subject Headings

  • Young Adult
  • Vaccination
  • United States
  • Troponin
  • RNA, Messenger
  • Quality of Life
  • Pandemics
  • Myocarditis
  • Male
  • Humans