A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  0 to 20

Participation Criteria

Inclusion Criteria:

* Cohort 1/2:

1. Age \<21 years.
2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
* Cohort 3:

1. Age \<21 years.
2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
3. COVID-19-related disease

1. Acute COVID-19 infection OR
2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
4. Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY

1. Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:

* Elevated troponin above upper limit of normal
* Abnormal ECG or rhythm monitoring finding consistent with myocarditis
* Abnormal cardiac function or wall motion abnormalities on echocardiogram
* cMRI findings consistent with myocarditis OR
2. Confirmed myocarditis/pericarditis as defined by:

* Histopathologic confirmation of myocarditis OR
* Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.

Exclusion Criteria:

1. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
2. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:

1. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
2. Mitral valve prolapse with \< trivial insufficiency
3. Hemodynamically insignificant atrial septal or ventricular septal defects.
3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).