Prospective Cases of New Onset Myocarditis/Pericarditis or cTnT Elevation Following Immunization with Either Smallpox or Trivalent Influenza Vaccine.

*Healthy 2002: DoD Defense Medical Surveillance System pre-SPX MP incidence data.3
‡Prospective clinical myocarditis/pericarditis cases included 4 Caucasian male cases of probable myocarditis (new onset cardiac symptoms (chest pain, dyspnea on exertion and/or at rest, palpitations) and cTnT elevations ≥0.02 ng/ml with the pre-vaccine level <0.01 ng/ml). The 5th case (female) was acute suspect pericarditis presenting with characteristic chest pain and no cTnT elevations or ECG changes. There were no cases in the TIV prospective study cohort.
§Comparison of Prospective Smallpox Vaccine Cohort with published historic retrospective epidemiologic estimate of myocarditis/pericarditis disease incidence in comparable population pre-SPX vaccine: P<0.001.
ǁSubclinical myocarditis is defined by increases in cTnT (above pre-immunization levels) without classic new onset cardiac symptoms. The comparison cohort does not reflect a dynamic change but a single level in time in healthy population subsequently followed for mortality relative risk. Possible subclinical pericarditis: There were no cases of possible subclinical pericarditis identified through the blinded ECG series review process.
Prospective Cases of New Onset Myocarditis/Pericarditis or cTnT Elevation Following Immunization with Either Smallpox or Trivalent Influenza Vaccine.