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. (November 2022)

• Record Type: Journal Article
• Authors: Kracalik, Ian; Oster, Matthew E; Broder, Karen R; Cortese, Margaret M; Glover, Maleeka; Shields, Karen; Creech, C Buddy; Romanson, Brittney; Novosad, Shannon; Soslow, Jonathan; Walter, Emmanuel B; Marquez, Paige; Dendy, Jeffrey M; Woo, Jared; Valderrama, Amy L; Ramirez-Cardenas, Alejandra; Assefa, Agape; Campbell, M Jay; Su, John R; Magill, Shelley S; Shay, David K; Shimabukuro, Tom T; Basavaraju, Sridhar V; Campbell, Paula; Anugwom, Chidera; Arvelo Jefferson, Colenda; Badger, Kimberly; Bafford, Nastocia; Barnes, Chandra; Boles, Stephanie; Collins, Emory; Desai, Mitesh; Dulski, Theresa; Dyleski, Barbara; Edwards, Kathryn; Feyereisen, Melanie; Gonsahn, Stephanie; Gregory, Tchernavia; Gunta, Jyothi; Jacobs Slifka, Kara; Kabore, Charlotte; Kapella, Bryan K.; Karol, Susan; Kennebrew, Kalah; Kluisza, Nancy; Lang, Sean; Lanier Gholston, Labretta; Law, Marcella; Lehman, Jennifer; Mazurek, Jacek M.; McGruder, Henraya; McNamara, Kiara; Moore, Maria-Luisa; Moro, Pedro; Moroney, John F.; Museru, Oidda; Nale, Cassandra; Neiman, Andi; Newsome, Kim; Odom, Erika; Pantazides, Brooke; Patel, Suchita; Rao, Agam; Reynolds, Laura; Robinson, Sonya; Ruberg, Frederick L.; Schaeffer, Tammy; Solanky, Dipesh; Sperling, Laurence; Stanley, Toscha; Sullivan, Regina; Taylor, Allan; Thomas, Kimberly; Thompson, Shayle; Tola, Jigsa; Tran, Cuc H.; Wiersma, Steven; Works, Kimberly;
• Is Part Of: Lancet. Volume 6:Number 11(2022)
• Page Start: 788
• Page End: 798
• Publication Date: 2022-11
• Subjects: Pediatrics -- Periodicals; Children -- Health and hygiene -- Periodicals; Adolescent medicine -- Periodicals; Teenagers -- Health and hygiene -- Periodicals; 618.920005
• DOI: 10.1016/S2352-4642(22)00244-9
• Languages: English
• ISSNs: 2352-4642

Abstract

Summary: 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.