Table 1.
Summary of studies related to COVID‐19 post‐vaccination myocarditis
| Type of study | Data source | Type of vaccine | Total study population (n) | Total cases of myocarditis (n) | Fulminant myocarditis (n) | Cumulative incidence | Highest incidence | Characteristics of group with highest incidence | Male (%) | Method of diagnosis | Reference |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Population study | Danish nationwide registry |
BNT162b2 mRNA vaccine (Pfizer‐BioNTech) mRNA‐1273 vaccine (Moderna) Ad26.COV2.S vaccine (adenovirus, Janssen/Johnson&Johnson) |
4 931 775 3 981 109 (received) BNT162b2 mRNA and mRNA‐1273 vaccine |
69 (among BNT162b2 mRNA and mRNA‐1273 vaccine) | NA | 1.7 per 100 000 individuals after mRNA vaccine | 5.7 per 100 000 individuals after mRNA vaccine |
mRNA‐1273 vaccine in 12–39 years BNT162b2 mRNA vaccine in women 12–39 years |
73 | ICD‐10 codes for myocarditis I40.0, I40.1, I40.9, I41.1, I41.8, I51.4 | Husby et al.19 |
| Population study | KPSC System |
50%: BNT162b2 mRNA vaccine (Pfizer‐BioNTech) |
1 dose: 2 392 924 | 2 | 0 | 0.08 (0.02–0.33) per 100 000 individuals | 0.58 per per 100 000 individuals | 2 doses | 100 | Reports from clinicians to KPSC | Simone et al.20 |
|
50%: mRNA‐1273 vaccine (Moderna) |
2 doses: 2 236 851 | 13 | 0.58 (0.34–1) per 100 000 individuals | ||||||||
| Population study | Beth Israel Deaconess Medical Center; Massachusetts Information System |
BNT162b2 mRNA vaccine (Pfizer‐BioNTech) mRNA‐1273 vaccine (Moderna) Ad26.COV2.S vaccine (adenovirus, Janssen/Johnson&Johnson) ChAdOx1 vaccine (adenovirus, AstraZeneca) |
268 320 | 10 | NA | 3.72 per 100 000 individuals | NA | 2 doses of RNA vaccine | 50 | ESC diagnostic criteria | Farahmand et al.7 |
| Pharmacovigilance study | Moderna global safety database | mRNA‐1273 vaccine (Moderna) | Approx. 151 100 000 | 1439 | 21 | 0.95 per 100 000 individuals | 7.40 per 100 000 individuals |
Male 18–24 years 2 doses |
78 | Collection: mostly based on adverse event reports submitted voluntarily. Verification: definition of the Brighton Collaboration and CDC | Straus et al.18 |
| Population study | Clalit Health Services (largest national healthcare organization) | BNT162b2 mRNA vaccine (Pfizer‐BioNTech) | 2 558 421 | 54 | 1 | 2.13 (1.56–2.70) per 100 000 individuals | 10.69 (6.93–14.46) per 100 000 individuals |
Male 16–29 years |
94 | Screening: ICD‐9 (codes 422, 429.0, 398.0 and 391.2). Verification: definition of the CDC 1 | Witberg et al.8 |
| Population study | Ministry of Health | BNT162b2 mRNA vaccine (Pfizer‐BioNTech) | 1 dose: 5 442 696 | 19 | 1 | 0.34 per 100 000 individuals | 1.91 per 100 000 individuals |
Male 20–24 years |
89 | Screening: ICD‐9 (codes 422.0‐9x and 429.0x). Verification: definition of the Brighton Collaboration | Mevorach et al.9 |
| 2 doses: 5 125 635 | 117 | 2,28 per 100 000 individuals | 15.07 per 100 000 individuals |
Male 16–19 years |
86 | ||||||
| Safety and efficacy study | Multinational, phase 3, placebo‐controlled, observer‐blinded trial, in 16‐year and older individuals | BNT162b2 mRNA vaccine (Pfizer‐BioNTech) | 21 720 | 0 | 0 | 0 | 0 | NA | NA | NA | Polack et al.22 |
| Safety and efficacy study | Ongoing phase 2–3, placebo‐controlled trial, in 12–17‐year‐old adolescents | mRNA‐1273 vaccine (Moderna) | 2489 | 0 | 0 | 0 | 0 | NA | NA | NA | Ali et al.23 |
| Population study | US Military Health System |
BNT162b2 mRNA vaccine (Pfizer‐BioNTech) mRNA‐1273 vaccine (Moderna) |
2 810 000 | 23 | NA | 0.82 per 100 000 doses | 1.9 per 100 000 doses | 2 doses | 100 | Vaccine Adverse Events Reporting System | Montgomery et al.21 |
| Safety and efficacy study | Multinational, placebo‐controlled, observer‐blinded trial, in 12–15‐year‐old adolescents | BNT162b2 mRNA vaccine (Pfizer‐BioNTech) | 2260 | 0 | 0 | 0 | 0 | NA | NA | NA | Frenck et al.24 |
| Safety and efficacy study | Multicentre (US), phase 3, placebo‐controlled, observer‐blinded trial, persons at high risk for SARS‐CoV‐2 infection or its complications | mRNA‐1273 vaccine (Moderna) | 15 210 | 0 | 0 | 0 | 0 | NA | NA | NA | Baden et al.25 |
CDC, Centers for Disease Control and Prevention; ESC, European Society of Cardiology; ICD, International Classification of Diseases; KPSC, Kaiser Permanente Southern California; NA, not available; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus 2.