The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age \<21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received any dose(s) of COMIRNATY within 21 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are 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. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Composite findings of myocarditis
Timeframe: 6 months after illness onset
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Timeframe: Up to 5 years following illness onset.
Myocarditis by original or revised Lake Louise criteria on cMRI
Timeframe: Up to 5 years following illness onset.
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Timeframe: Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Timeframe: Up to 5 years following illness onset.
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Timeframe: Up to 5 years following illness onset.
The Pediatric Quality of Life Inventory (PEDS QL)
Timeframe: Up to 5 years following illness onset.
The Quality of Life Scale (QOLS)
Timeframe: Up to 5 years following illness onset.
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Timeframe: Up to 5 years following illness onset.