Age: 54.0
Sex: M
Vaccine: ANTH, SMALL, VARCEL, ANTH, SMALL, VARCEL
Symptoms: Coxsackie virus test positive, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Exercise tolerance decreased
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 632375. This case involves a 54-years old (also reported as 52 year old) male patient who received the following vaccinations on 22 January 2014: A third dose of ACAM2000 (lot number-VV04-003A, site of administration was reported as left arm, and route of administration was reported as percutaneous (also reported as intradermal)), a dose of VARIVAX (manufacturer: Merck, lot number- H017704, route and site of administration was reported as unknown), third dose of BIOTHRAX (lot number- FAV317A, manufacturer-Emergent) route and site of administration was reported as unknown. The patient's other medication included EFFEXOR, PERCOCET and LIPITOR. Patient's medical history included left shoulder strain, TIA (transient ischemic attack), insomnia, skin neoplasm, hyperlipidemia; osteoarthritis of the hand, upper back pain. Patient had no personal or family history of autoimmune disease, no previous work-up for viral causes of cardiomyopathy and no other complaints. Patient's current illness was reported as none and prior vaccination was not reported. Patient denied any previous AEFI. The patient denied any immediate symptoms and reported no significant LLR or robust take was noticed with this. It was reported that on 01 March 2014 (also reported as from Mar - Jun 2014), one month seven days post vaccination patient began to note a decline in exertional tolerance. On 01 March 2014, one month seven days post vaccination, patient experienced asthenia, cardiac disorder, catheterisation cardiac abnormal, congestive cardiomyopathy, coronary artery disease, coxsackie virus test positive (elevated titer showed by serology), echocardiogram abnormal, ejection fraction decreased (also reported as decreased LVEF), electrocardiogram abnormal, mitral valve incompetence, mitral valve repair/ surgical intervention (also reported as severe MR which was evaluated with ECG and echocardiogram), cardiac rehabilitation, hypokinesia/ ventricular hypokinesia (global LV hypokinesis with dilated LV and a focal area of hyper-enhancement showed by cMRI performed at another Medical Center), nuclear magnetic resonance imaging abnormal, nuclear magnetic resonance imaging heart, scan with contrast abnormal, the key finding of dilated non-ischemic CM with severe MR was thought to be secondary to posterior leaflet restriction due to underlying inferolateral wall motion abnormality. The patient desired causality assessment. Patient was followed by another Cardiologist. It was reported that clinical notes showed patient's first visit for such complaint was 1 June 2014. It was reported that patient required emergency visit and was hospitalized on an unspecified date. Patient denied any problems with prior Smallpox vaccine. Other Laboratory data was not reported. On an unspecified date, patient was recovered from events. This case was considered serious due to life threatening events. List of documents held by sender: none. "There might be a discrepancy between the event date field (01-March-2014) and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date field". Sender's Comments: "Case of dilated non ischemic cardiomyopathy (DCM) with severe mitral regurgitation in a 54 year old male who developed decreased exercise tolerance approximately 2-4 months after receiving his third smallpox vaccination. The etiology of DCM often cannot be determined. Based on the information provided genetic, ischemic, and valvular heart disease appear less likely causes of the reported DCM, although these cannot be ruled out. History of alcohol or cocaine use were not reported. Increased titers of Coxsackie B6 virus (CBV), a known cause of myocarditis, confirms a recent/current infection. The latency for progression of viral myocarditis to DCM and for the rate of development of severe mitral valve regurgitation secondary to DCM are unknown. The time taken for such developments in this patient is not provided. Because other viruses are known to cause DCM, the occurrence of DCM after smallpox vaccination is plausible, although not previously described. History of cardiac disease or risk factors increases the risk of cardiac complications post smallpox vaccination. Smallpox myocarditis typically occurs within 30 days post vaccination and has low incidence in re-vaccinees. Also, endomyocardial biopsy was not performed. Although it is not possible to rule out smallpox vaccine as the etiology of reported DCM in this patient, it is less likely than CBV infection and idiopathic DCM."