Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Ejection fraction normal, Electrocardiogram normal, Exercise test normal, Influenza like illness, Myopericarditis
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012, who also provided an adjudication follow-up report. A male subject, who at the time of the report, was in this thirties (date of birth and age at time of vaccination not reported) had received the follow vaccinations on 10 July 2009: an injection of ACAM2000 (SP Biologics Co.), an injection of TYPHIM VI, sanofi pasteur SA and and injection of Anthrax Vaccine (manufacturer not reported) (lot numbers, routes and sites of administration not reported). On 21 July 2009 (also reported as 13 days post-vaccination), the subject was diagnosed with other, chest pain. According to the adjudication follow-up report received, the subject was referred to cardiology for a history of probable vaccinia-induced myocarditis. At 11 days post-vaccination the subject developed flu-like symptoms and by 13 days post-vaccination the subject developed chest pain (CP) and dyspnea. Pain was described as substernal CP, pressure, with both pleuritic and positional components. The subject presented to the emergency department (ED) and initial troponin levels were elevated. The subject was hospitalized and treated with non-steroidal anti-inflammatory drugs (NSAIDS) and diagnosed with myopericarditis by elevated troponin levels. Troponin peaked at 0.041 at 13 days post-vaccination and trended downward from that point. The subject had a normal electrocardiogram (ECG) 12 days post-vaccination. The subject's echocardiogram (ECHO) on 12 days post-vaccination revealed normal sinus rhythm (NSR) throughout, left ventricle was normal in size, thickness and function, ejection fraction (EF) was 55-60%, no definite regional wall motion abnormalities detected within the limits of the study, normal ventricular systolic and diastolic function and no pericardial effusion. On day 34 post-vaccination, the subject presented without complaints, no CP or shortness of breath (SOB). The subject was able to ride a bicycle at moderate pace without unusual symptoms (sx). The subject's ECHO was normal, with normal systolic and diastolic function. On day 67 post-vaccination, the subject was doing well for several weeks, was asymptomatic at modest levels of exercise and denied symptoms of CP or undue dyspnea on exertion. On day 87 post-vaccination, the subject's exercise stress test (GXT) was normal. On day 88 post-vaccination, the subject had very good exercise tolerance without sx or ECG changes. A/P: 1) Myocarditis. The subject was without symptoms related to (r/t) diagnosis. The testing demonstrated normal cardiac function. The subject was cleared to resume regular exercise and standard military duty without restrictions, including the upcoming deployment. On day 89 post-vaccination, the subject's ECHO revealed no acute change from previous test on file, was within normal limits (WNL), EF 55-60%, no wall motion abnormalities and no pericardial effusion. No further information was available at the time of the report. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.