Table 3.
Spontaneous reports of myocarditis and pericarditis on the VAERS database following COVID-19 mRNA vaccines in immunocompromised individuals subdivided into time to onset and vaccine dosage
| Reports to VAERS | |||||||||||||||
| Immunocompromised characteristic | Outcome | Vaccine dose | Time to onset of symptoms | ||||||||||||
| N | % (95% CI) | Dose 1 | Dose 2 | Dose 3 | Unknown dose | <14 days | >14 days | ||||||||
| N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | ||||
| Transplant | Myocarditis | 1 | 11.1 (0.3 to 48.2) | 0 | 0.00 | 2 | 22.2 (2.8 to 60.0) | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 2 | 22.2 (2.8 to 60.0) |
| Pericarditis | 5 | 55.6 (21.2 to 86.3) | 1 | 11.1 (0.3 to 48.2) | 2 | 22.2 (2.8 to 60.0) | 0 | 0.0 | 3 | 33.3 | 4 | 44.4 (13.7 to 78.8) | 2 | 22.2 (2.8 to 60.0) | |
| Myopericarditis | 3 | 33.3 (7.5 to 70.1) | 1 | 11.1 (0.3 to 48.2) | 1 | 11.1 (0.3 to 48.2) | 0 | 0.0 | 0 | 0.0 | 1 | 11.1 (0.3 to 48.2) | 1 | 11.1 (0.3 to 48.2) | |
| Total | 9 | 100.0 | 3 | 33.3 (7.5 to 70.7) | 3 | 33.3 (7.5 to 70.7) | 0 | 0.0 | 3 | 33.3 (7.5 to 70.7) | 4 | 44.4 (13.7 to 78.8) | 5 | 55.6 (21.2 to 86.3) | |
| Methotrexate | Myocarditis | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Pericarditis | 8 | 88.9 (51.8 to 99.7) | 4 | 44.4 (13.7 to 78.8) | 4 | 44.4 (13.7 to 78.8) | 0 | 0.0 | 0 | 0.0 | 6 | 66.7 (29.9 to 92.5) | 1 | 11.1 (0.3 to 48.2) | |
| Myopericarditis | 1 | 11.1 (0.3 to 48.2) | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 11.1 (0.3 to 48.2) | 1 | 11.1 (0.3 to 48.2) | 0 | 0.0 | |
| Total | 9 | 100.0 | 4 | 44.4 (13.7 to 78.8) | 4 | 44.4 (13.7 to 78.8) | 0 | 0.0 | 1 | 11.1 (0.3 to 48.2) | 7 | 77.8 (40.0 to 97.2) | 1 | 11.1 (0.3 to 48.2) | |
| HIV | Myocarditis | 2 | 28.6 (3.7 to 71.0) | 1 | 14.3 (0.4 to 57.9) | 1 | 14.3 (0.4 to 57.9) | 0 | 0.0 | 0 | 0.0 | 2 | 28.6 | 0 | 0.0 |
| Pericarditis | 4 | 57.1 (18.4 to 90.1) | 3 | 42.9 (9.9 to 81.6) | 1 | 14.3 (0.4 to 57.9) | 0 | 0.0 | 0 | 0.0 | 4 | 57.1 (18.4 to 90.1) | 0 | 0.0 | |
| Myopericarditis | 1 | 14.3 (0.4 to 57.9) | 0 | 0.0 | 1 | 14.3 (0.4 to 57.9) | 0 | 0.0 | 0 | 0.0 | 1 | 14.3 (0.4 to 57.9) | 0 | 0.0 | |
| Total | 7 | 100.0 | 4 | 57.1 (18.4 to 90.1) | 3 | 42.9 (9.9 to 81.6) | 0 | 0.0 | 0 | 0.0 | 7 | 100.0 | 0 | 0.0 | |
| Cancer therapeutics | Myocarditis | 10 | 32.3 (16.7 to 51.4) | 2 | 6.5 (0.8 to 21.4) | 6 | 19.4 (7.5 to 37.5) | 1 | 3.2 (0.1 to 16.7) | 1 | 3.2 (0.1 to 16.7) | 8 | 25.8 (11.9 to 44.6) | 2 | 6.5 (0.8 to 21.4) |
| Pericarditis | 17 | 54.8 (36.0 to 72.7) | 4† | 12.9 (3.6 to 29.8) | 11 | 35.5 (19.2 to 54.6) | 2 | 6.5 (0.8 to 21.4) | 0 | 0.0 | 10† | 32.3 (16.7 to 51.4) | 7 | 22.6 (9.6 to 41.1) | |
| Myopericarditis | 4 | 12.9 (3.6 to 29.8) | 0 | 0.0 | 2 | 6.5 (0.8 to 21.4) | 2 | 6.5 (0.8 to 21.4) | 0 | 0.0 | 3 | 9.7 (2.0 to 25.8) | 0 | 0.0 | |
| Total | 31 | 100.0 | 6 | 19.4 (7.5 to 37.5) | 19 | 61.3 (42.2 to 78.2) | 5 | 16.1 (5.5 to 33.7) | 1 | 3.2 (0.1 to 16.7) | 21* | 67.7 (48.6 to 83.3) | 9* | 29.0 (14.2 to 48.0) | |
| All | Total | 56 | 100.0 | 17 | 28.1 (18.8 to 44.1) | 31 | 55.4 (41.5 to 68.7) | 5 | 8.9 (3.0 to 19.6) | 5 | 8.9 (3.0 to 19.6) | 39 | 69.6 (55.9 to 81.2) | 15 | 26.8 (15.8 to 40.3) |
Reports of myocarditis, pericarditis or myopericarditis were searched in the VAERS database following COVID-19 mRNA vaccines, either Moderna or Pfizer/BioNTech. The resultant reports were further assessed for individuals that were likely to be immunocompromised based on the following search terms (transplant, immunosuppressant drugs; tacrolimus, mycophenolate mofetil, methotrexate, prednisolone, ciclosporin and steroids, HIV or approved cancer therapeutics: https://www.cancer.gov/about-cancer/treatment/drugs). Values indicate the events recorded and as a percentage of the total in each of the four characteristic categories with 95% CIs.
*n=1, unspecified time to onset.
†n=1, fatality.
mRNA, messenger RNA; VAERS, Vaccine Adverse Event Reporting System.