MARCH 16, 2023
• “There is evidence that suggests patients who receive a COVID-19 vaccine are at an increased risk of myocarditis.”
• “Onset was typically within several days after mRNA COVID-19 vaccination (from Pfizer or Moderna), and cases have occurred more often after the second dose than the first dose.” [PAGE 19]
• “The reasons for male predominance in myocarditis and pericarditis incidence post COVID-19 vaccination remain unknown.” [PAGE 28]
• “The pattern of cases conform, as per the label, to a pattern of myocarditis cases occurring in majority of young males below 29 years of age within the first two weeks postvaccination…” [PAGE 19]
• “Since April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults (CDC 2021).” [PAGE 18]
• “Myocarditis events were defined as encounters with a billing or encounter diagnosis consistent with an ICD10-CM or SNOMED CT code for myocarditis which fell within two weeks of receiving dose 1, 2, or 3 of the Pfizer COVID-19 vaccine.”
• “Incidence rates of myocarditis were measured for each vaccine dose with denominator signifying the total number of patients receiving that dose and numerator signifying the total number of patients meeting the above criteria for an encounter for myocarditis following that dose.”
