Table 1.
Myocarditis/pericarditis epidemiologic case definitions: Centers for Disease Control and Prevention (CDC) [10, 18].
Fig 1.
Smallpox vaccine program 2002–2016 date of immunization: Vaccine Adverse Event Reporting System (VAERS) data available with iterative database searches ldentifying subsets of cases with new onset cardiac symptoms and then meeting the 2003 epidemiologic case definition for myocarditis/pericarditis.
Box 1: Vaccination Dates: Dec 2002–2016: Data Source: CDC/FDA VAERS Database using CDC Wonder Search tool. Accessed June 2020. https://wonder.cdc.gov. Box 2: Cardiac Symptoms/Diagnoses by MedDRA Terms (see S1 Table): All Ages, Locations, No Limits (1081) = then Limit Symptom Onset Day 1–60 = then Limit to Military. Box 3: Final Cohort of myocarditis and pericarditis with smallpox vaccine association using CDC case definitions (2003: See Table 1). Box 4a and 4b (left to right): Myocarditis and Pericarditis cases detailed by level of certainty for diagnostic accuracy based on criteria in CDC case definitions with no other etiology identified.
Table 2.
Distribution of myocarditis and pericarditis cases by source of initial contact (including 4 deaths).
Table 3.
Myocarditis/Pericarditis (MP) cohort (alive 8 weeks post SPV with data for adjudication) demographics compared to the total immunized population by the Military Health System (MHS): December 1, 2002-December 31, 2016.
Table 4.
Comparison of myocarditis and pericarditis clinical characteristics.
Table 5.
Frequencies of abnormal cardiac tests by diagnosis (Myocarditis and pericarditis).
Table 6.
Comparison of rates and timeline (years) of recovery after SPV myocarditis versus pericarditis with associated measures of cardiac injury at baseline.
Fig 2.
Timeline of myocarditis/pericarditis case recovery percent after date of vaccination.
Table 7.
Comparison of MP cases by recovery rates (less than one year versus prolonged or no recovery after one year or longer) for baseline measures of cardiac injury, function, cardiac risk factors, and acute treatment.
Table 8.
Comparison of Myocarditis cases by recovery rates (less than 1 year versus prolonged or no recovery after 1 year or longer) for baseline measures of cardiac injury, function, cardiac risk factors, and acute treatment.
Table 9.
Characteristics of four acute deaths with evidence of myocarditis or pericarditis following SPV.