Table 3.
Case series of longer term follow-up of myocarditis or pericarditis after mRNA covid-19 vaccination (question four)
| Case series (country) | Chelala 2021 (US) | Patel 2021 (US) | Klein 2022 (US) |
|---|---|---|---|
| Date of cases | 14 June 2021 | May 2021-June 2021 | 25 December 2021 |
| No of cases | 5 | 9 | 43 |
| Confirmed cases | Clinically confirmed through review of medical records, results of biochemical laboratory testing, ECG results, and findings from echocardiography, cardiac MRI; met 2018 Lake Louise criteria | Diagnoses reviewed and met the CDC case definition and troponin elevation | ICD-10 used then diagnoses confirmed by medical record review |
| Case source | Single medical centre in US | Single medical centre in Atlanta, US | Kaiser Permanente in Colorado, Oregon, California, and Washington; HealthPartners Institute Minnesota; Denver Health |
| Myocarditis (No (%)) | 5 (100) | 9 (100) | 23 (53) |
| Pericarditis (No (%)) | 0 | 0 | 2 (5) |
| Myopericarditis (No (%)) | 0 | 0 | 18 (42) |
| Male (No (%)); female (No (%)) | 5 (100); 0 (0) | 9 (100); 0 (0) | 37 (86); 5 (14) |
| Age (years) | Mean 17 (range 16-19) | 15.7 (IQR 14.5-16.6) | 29 (67%) 12-15 years; 14 (33%) 16-17 years |
| Vaccine product (No (%)) | 4 (80) BNT162b2 (Pfizer); 1 (20) mRNA-1273 (Moderna) | 9 (100) mRNA vaccine | 43 (100) BNT162b2 (Pfizer) |
| In intensive care unit (No (%)) | NR | 2 (22) | 11 (26) |
| Admitted to hospital (No (%)) | 5 (100) | 9 (100) | 28 (65) |
| Presenting after second vaccination (No (%)) | 5 (100) | 8 (89) | NR |
| History of covid-19 (No (%)) | 0 | NR | 2 (5) |
| Positive result on polymerase chain reaction test for covid-19 (No (%)) | 0 | NR | NR |
| Patients with covid nucleocapsid antibody present (among tested) (No (%)) | NR | NR | NR |
| Patients with SARS-CoV-2 spike antibody (No (%)) | NR | NR | NR |
| Previous myocarditis or pericarditis history (No (%)) | None reported | NR | 2 (5%) |
| Median time between last vaccine and symptom onset, days, (range) | 4 (3-4) | 3 between 2nd vaccination and hospital admission | 2 (0-20) |
| Chest pain on presentation (No (%)) | 5 (100) | 9 (100) | NR |
| Other symptoms (eg, myalgia, fatigue, fever; (No (%)) | NR | 4 (44) dyspnoea | NR |
| Troponin elevation (among tested; No (%)) | 5 (100, all tested) | NR | NR |
| Median time to troponin peak after vaccination (days) | NR | NR | NR |
| BNP or N-terminal-proBNP elevation (among tested; No (%)) | 0; normal (4/4 tested) | NR | NR |
| CRP elevation (among tested; No (%)) | 4 (80%, 5/5 tested) | NR | NR |
| Patients with eosinophilia (among tested) | NR | NR | NR |
| Abnormal ECG (among tested; No (%)) | 2 (40, 5/5 tested); ST segment elevation (1 patient), sinus bradycardia (1 patient), normal (3 patients) | 6 (67, 9/9 tested); repolarisation abnormalities (6 patients), normal (3 patients) | NR |
| Abnormal cardiac MRI (among tested; No (%)) | 5 (100, 5/5 tested); no segmental wall motions abnormalities, and basilar and mid-cavity involvement; early and late gadolinium enhancement | NR | NR |
| Abnormal ECG (among tested; No (%)) | 2 (40, 5/5 tested); LVEF mildly to moderately decreased and associated with global hypokinesis (1 patient), ectasia of right coronary artery and left anterior descending artery (1 patient), normal (3 patients) |
Median (IQR) LVEF at presentation=60 (58-67) | NR |
| Patients with LVEF <50% (among tested; No (%)) | 1 (20) | 2 (22) with 30-55% LVEF at presentation; 7 (78) with >55% LVEF at presentation | NR |
| Symptoms resolved (No (%)) | 5 (100) | NR | 43 (100) discharged home |
| Fatalities (No (%)) | 0 | 0 | 0 |
| Median (range) length of stay in hospital (days) | 3 (3-9) | NR | 2 (0-7) |
| Treated with medications for myocarditis (No (%)) | Prescribed at discharge: 1 (20) colchicine and metoprolol; 1 (20) metoprolol; 1 (20) NSAID; 1 (20) aspirin | 8 (89) other NSAID if no aspirin; 2 (22) vasopressors; 1 (11) IVIG; 1 (11) aspirin; 0 steroids | NR |
| Patients with follow-up data (No (%)) | 5/5 (100) | 9/9 (100) | 24/43 (56) |
| Mean (range) length of clinical follow-up (days) | 95 (92-104) | 90 (NR) | 88.5 (28-153) |
| Repeat cardiac MRI (No (%)) | 2 (40) | NR | 1 (4) |
| Characteristics of repeat cardiac MRI | 2 performed, both stable biventricular size and function; persistent, but decreased, LGE that was similar in distribution to the initial MRI; and an absence of new areas of abnormality | NR | Normal findings |
| Symptoms such as chest pain (No (%)) | 3 (60); mild intermittent self-resolving chest pain after discharge; in one patient recurrent symptoms occurred after discontinuation of the NSAID prescribed at discharge | NR | 9 (38) chest pain; 3 (13) shortness of breath; 3 (13) palpitations; 1 (4) fatigue; 3 (13) other (eg, orthostatic hypotension, dizziness) |
| Medical visits following discharge (No (%)) | 3 (60); recurrent symptoms resulted in an emergency department visit | ECG findings at clinic follow-up (1-2 weeks after discharge): 1 of 6/9 tested (17) repolarisation abnormalities, 5 of 6/9 tested (83) normal | 18 (75) electrocardiogram, with abnormal findings in 9 (50) patients; 17 (71) ECG, with abnormal findings in 2 (12) patients |
| Continued treatment with medications (No (%)) | NR | 0 on heart failure medication | 2 (8) still on medication (eg, NSAIDs, colchicine) |
| Recovered with no symptoms (No (%)) | NR | NR | 11 (46) no symptoms, medications, or exercise restrictions |
BNP=B type natriuretic peptide; CDC=Centers for Disease Control and Prevention; CRP=C reactive protein; ECG=echocardiogram; ICD=International Classification of Diseases; ICU=intensive care unit; IQR=interquartile range; IVIG=intravenous immune globulin; LGE=late gadolinium enhancement; LVEF=left ventricular ejection fraction; MRI=magnetic resonance imaging; NA=not applicable; NR=not reported; NSAID=non-steroidal anti-inflammatory drugs; PHAC=Public Health Agency of Canada.