Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Tejtel, S. Kristen Sexson; Al-Ammouri, Iyad; Savorgnan, Fabio; Guggilla, Rama; Khuri‐Bulos, Najwa; Phillips, Lee; Engler, Renata J.M.

doi:10.1016/j.vaccine.2021.11.074

“…The diagnostic criteria for myocarditis and degree of certainty of diagnosis were adapted from the case definition and classification of the Brighton Collaboration [ 7 ]. Although our patient did not undergo endomyocardial biopsy, troponin I level was elevated, and cardiac magnetic resonance imaging and echocardiography demonstrated left ventricular abnormalities.…”

Section: Discussionmentioning

confidence: 99%

Myocarditis Following the Second Dose of COVID-19 Vaccination in a Japanese Adolescent

Yamamoto¹,

Arita²,

Ogasawara³

2022

Cureus

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As COVID-19 vaccines continue to be deployed worldwide, countries are now planning to vaccinate their pediatric populations as well. However, several vaccine-related adverse events, including myocarditis, have been reported. Although the incidence of myocarditis after BNT162b2 vaccination is low, it is higher, particularly after receiving the second dose, among young male recipients. A 13-year-old male adolescent presented with chest pain after the second dose of the BNT162b2 vaccination. Electrocardiography, echocardiography, cardiac magnetic resonance imaging, and blood examinations were consistent with myocarditis. He was treated conservatively because his symptoms were relatively mild. In Japan, it is expected that the chances of diagnosing vaccine-related myocarditis will increase as more children are getting vaccinated. Our case report raises concerns to physicians that the COVID-19 vaccination may cause rare cases of myocarditis, which must always be considered as a differential diagnosis.

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“… 10 , 11 The diagnostic criteria, classification, and degree of certainty of myocarditis were adapted from the case definition of the Brighton Collaboration and the position statement of the European Society of Cardiology (ESC) Working Group on Myocardial and Pericardial Diseases for clinically suspected myocarditis. 12 , 13 …”

Section: Methodsmentioning

confidence: 99%

A prospective study on myocardial injury after BNT162b2 mRNA COVID‐19 fourth dose vaccination in healthy persons

Levi

¹

,

Moravsky

²

,

Weitsman

³

et al. 2022

European J of Heart Fail

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Aims To prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer‐BioNTech) against COVID‐19. Methods and results Health care workers who received the BNT162b2 vaccine during the fourth dose campaign had blood samples collected for high‐sensitivity cardiac troponin (hs‐cTn) during vaccine administration and 2–4 days afterward. Vaccine‐related myocardial injury was defined as hs‐cTn elevation above the 99th percentile upper reference limit and >50% increase from baseline measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis. Of 324 participants, 192 (59.2%) were female and the mean age was 51.8 ± 15.0 years. Twenty‐one (6.5%) participants had prior COVID‐19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days. Reported vaccine‐related adverse reactions included local pain at injection site in 57 (17.59%), fatigue in 39 (12.04%), myalgia in 32 (9.88%), sore throat in 21 (6.48%), headache in 18 (5.5%), fever ≥38°C in 16 (4.94%), chest pain in 12 (3.7%), palpitations in 7 (2.16%), and shortness of breath in one (0.3%) participant. Vaccine‐related myocardial injury was demonstrated in two (0.62%) participants, one had mild symptoms and one was asymptomatic; both had a normal electrocardiogram and echocardiography. Conclusion In a prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy health care workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT05308680.

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“…Victoria is a south-eastern Australian state with a population of approximately 6.6 million 13. Adverse events following immunisation (AEFI) are spontaneously reported by patients, caregivers or healthcare providers to Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), the state-wide vaccine safety service 14. SAEFVIC comprises central reporting enhanced passive and active surveillance systems integrated with clinical services and has been operating since 2007.…”

Section: Methodsmentioning

confidence: 99%

Myocarditis and myopericarditis cases following COVID-19 mRNA vaccines administered to 12–17-year olds in Victoria, Australia

Cheng

¹

,

Clothier

²

,

Morgan

³

et al. 2022

bmjpo

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Importance COVID-19 mRNA vaccine-associated myocarditis has previously been described; however specific features in the adolescent population are currently not well understood. Objective To describe myocarditis adverse events following immunisation reported following any COVID-19 mRNA vaccines in the adolescent population in Victoria, Australia. Design Statewide, population-based study. Setting Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) is the vaccine-safety service for Victoria, Australia. Participants All SAEFVIC reports of myocarditis and myopericarditis in 12–17-year-old COVID-19 mRNA vaccinees submitted between 22 February 2021 and 22 February 2022, as well as accompanying diagnostic investigation results where available, were assessed using Brighton Collaboration criteria for diagnostic certainty. Exposures Any mRNA COVID-19 vaccine. Main outcomes/Mmeasure Confirmed myocarditis as per Brighton Collaboration criteria (levels 1–3). Results Clinical review demonstrated definitive (Brighton level 1) or probable (level 2) diagnoses in 75 cases. Confirmed myocarditis reporting rates were 8.3 per 100 000 doses in this age group. Cases were predominantly male (n=62, 82.7%) and post dose 2 (n=61, 81.3%). Rates peaked in the 16–17-year-old age group and were higher in males than females (17.7 vs 3.9 per 100 000, p=<0.001). The most common presenting symptoms were chest pain, dyspnoea and palpitations. A large majority of cases who had a cardiac MRI had abnormalities (n=33, 91.7%). Females were more likely to have ongoing clinical symptoms at 1-month follow-up (p=0.02). Conclusion Accurate evaluation and confirmation of episodes of COVID-19 mRNA vaccine-associated myocarditis enabled understanding of clinical phenotypes in the adolescent age group. Any potential vaccination and safety surveillance policies needs to consider age and gender differences.

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Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Cited by 75 publications

References 70 publications

Myocarditis Following the Second Dose of COVID-19 Vaccination in a Japanese Adolescent

Myocarditis Following the Second Dose of COVID-19 Vaccination in a Japanese Adolescent

A prospective study on myocardial injury after BNT162b2 mRNA COVID‐19 fourth dose vaccination in healthy persons

Myocarditis and myopericarditis cases following COVID-19 mRNA vaccines administered to 12–17-year olds in Victoria, Australia

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