COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)

Patients who have developed symptoms after receiving a COVID-19 vaccine and meet the inclusion and exclusion criteria are eligible to participate in the registry.

Family members, vaccinated in a similar timeframe, with similar technology vaccine (e.g. any mRNA) but did not experience myocarditis side-effects - as a negative controls. If a relative is not available, voluntary controls who received the same type of COVID-19 vaccine in a similar time frame can be recruited (friends, roommates) Alternatively, if family members also had similar reactions, they can be recruited as positive controls.

For the retrospective registry, we would also collect data on COVID-19 myocarditis and pericarditis and all other etiologies of myocarditis or pericarditis.

Inclusion Criteria:

1. All patients eligible for vaccination with a COVID-19 vaccine,

2. At least one cardiac symptom of suspected myocarditis/pericarditis within 42 days of receiving a COVID-19 vaccination. The clinical symptoms include chest pain, pressure, or discomfort; dyspnea, shortness of breath/dyspnea/pain with breathing, palpitations, diaphoresis, syncope, or sudden death.

   OR At least two non-specific symptoms within 42 days of receiving a COVID-19 vaccination. These symptoms include fatigue, abdominal pain, dizziness or syncope, edema, or cough.

   OR In infants and young children, can also have at least two non-specific symptoms within 42 days of receiving a COVID-19 vaccination. These symptoms include irritability, vomiting, poor feeding, tachypnea, or lethargy.

   OR No symptoms, but abnormal histopathology or a combination of abnormal cardiac biomarkers with abnormal cardiac imaging (echo or MRI)

3. At least one of the following:

   1. a. Elevations in Troponin T, Troponin I, or CK-MB (above threshold of normal)
   2. Abnormal MRI (per Brighton Criteria Case Definitions, see Appendix 2 and 3)
   3. Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor (per Brighton Criteria Case Definitions, see Appendix 2 and 3) including those that normalize on recovery.
   4. Abnormal Echocardiographic findings (per Brighton Criteria Case Definitions, see Appendix 2 and 3)
   5. Physical exam finding: Pericardial friction rub or pulsus paradoxus
   6. Pericardial fluid or inflammation by imaging (echo, MRI, or CT) or at least one of the following elevated biomarkers of inflammation: ESR, CRP, hs-CRP, or D-Dimer.
   7. Enlarged heart on chest radiograph.
   8. Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation

Exclusion Criteria:

1. Clear alternative diagnosis or explanation for the symptoms and findings (e.g. infectious myocarditis such as Lyme carditis). Note: Work-up of alternative diagnosis is dependent on clinical presentation e.g. Lyme carditis (e.g. endemic area, season, bullseye rash) or autoimmune heart disease (e.g. arthritis, rash, recurrence).
2. Symptoms after 42 days of vaccination.