The main goal of this study is to characterize presentation, clinical course, andlong-term outcomes of myocarditis temporally associated with administration of mRNA-1273(SPIKEVAX) COVID-19 vaccine.
This is an observational cohort study that combines data collected directly from
healthcare providers (HCP) with existing retrospective real-world data as captured in
clinical electronic health record (EHR) and administrative claims data. Vaccine exposure
and case identification information will be obtained retrospectively from existing
real-world data to identify cases of post-vaccine myocarditis (PVM) and ultimately
vaccine-associated myocarditis (VAM) for potential study inclusion. Eligible participants
will be identified and followed for up to 5 years until the end of the study period or
loss to follow-up or death.
Inclusion Criteria:
- Participants with a diagnosis of myocarditis between December 18, 2020, and October
31, 2026, will be identified or who have a relevant combination of laboratory and
clinical findings meeting the CDC case definition for probable or confirmed
myocarditis will be included in the study.
- Participants will be required to have at least 30 days of medical history to assess
SPIKEVAX exposure.
Veradigm
Chicago, Illinois, United States
Not Provided