Pericarditis case definition for surveillance of adverse events after smallpox vaccination in the United States, 2003¹³.

<p>*<b>ECG findings</b>: Electrocardiogram findings not previously documented.</p><p>Pericarditis case definition for surveillance of adverse events after smallpox vaccination in the United States, 2003¹³.</p

Subject enrollment, exclusions and outcomes for two prospective cohorts, post-smallpox and annual trivalent influenza vaccine.

<p>Subject enrollment, exclusions and outcomes for two prospective cohorts, post-smallpox and annual trivalent influenza vaccine.</p

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

<p>*<b>Healthy 2002</b>: DoD Defense Medical Surveillance System pre-SPX MP incidence data.³</p><p>^‡<b>Prospective clinical myocarditis/pericarditis</b> 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 5^th 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.</p><p>^§<b>Comparison of Prospective Smallpox Vaccine Cohort with published historic retrospective epidemiologic estimate of myocarditis/pericarditis disease incidence in comparable population pre-SPX vaccine</b>: P<0.001.</p><p>^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. <b>Possible subclinical pericarditis</b>: There were no cases of possible subclinical pericarditis identified through the blinded ECG series review process.</p><p>Prospective Cases of New Onset Myocarditis/Pericarditis or cTnT Elevation Following Immunization with Either Smallpox or Trivalent Influenza Vaccine.</p