Age: 38.0
Sex: M
Vaccine: ANTH, RAB, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 27 February 2012. A 38-year-old male subject had received the following vaccinations: On 21 November 2011, an injection of ACAM2000 (lot number not reported), an injection of rabies vaccine (manufacturer and lot number not reported) and an injection of anthrax (manufacturer and lot number not reported). On 27 October 2011 influenza, live, intranasal (manufacturer and lot number not reported). On 02 December 2011, the subject had an abnormal troponin I result of 00.05, an abnormal ECG and an abnormal echocardiogram. The subject was diagnosed with unspecified disease of pericardium on 03 December 2011 and acute pericarditis, unspecified on 12 December 2011. The subject was admitted 11 days post-vaccination with chest pain (CP) and new onset of atrial fibrillation in context of recent smallpox vaccination. The subject had a possible (?) adverse reaction to smallpox vaccine (SPV), secondary to blood cultures positive for coagulase-negative staphylococcus. The subject was discharged 11 days post-vaccination on dicloxicillin four times a day (QID) for 3 days. The subject's diagnostic testing included labs 10 days post-vaccination Troponin I 0.029, 11 days post-vaccination troponin I 0.057 Peak, an echocardiogram (ECHO) 11 days post-vaccination "inpt limited study ejection fraction (EF) assessment only patient with atypical CP found to be in Afib with regular ventricular rate (RVR) impression: suspicious L ventricular function is low normal; EF=50% by symptoms; L ventricular wall motion normal." The subject was seen for a follow-up on 15 days post-vaccination. He reported no further episodes of rigors, although had occasional chills. The large erythematous patch on his left shoulder at the SPV inoculation site noted upon admission has entirely resolved. Labs on admission revealed mildly elevated troponins. The initial ECHO, while still in Afib showed a mild decreased in EF without focal wall motion abnormalities. The subject generally felt better (10 days post-vaccination) overnight. On 11 days post-vaccination the subject had spontaneously converted to normal sinus rhythm (NSR), but later noted feeling increasing short of breath (SOB), sweats and rigors. On 10 days post-vaccination the subject received Vancomycin for presumptive treatment (tx) of cellulitis. On 11 days post-vaccination one of 4 blood cultures became positive for gram-positive cocci in clusters. MRSA testing was negative. Subsequent blood cultures were negative. The subject was afebrile and slowly improving but continued to have mild SOB. The subject was on convalescent leave for 10 days. The subject continued improvement in studies - white blood cells (WBC's) decreased from admission levels, ALT mild elevation, CRP mildly elevated at 7.4. The subject's chest was clear to auscultation (CTA), bilaterally, cardiac was regular rate and rhythm (RRR), no murmurs, rubs or gallops, on the skin the erythematous patch on L shoulder resolved. "A/P 1. Systemic reaction to SPV-robust reaction on L shoulder 2. Myopericarditis - suspected 3. Leukocytosis - blood cultures positive for GPC  in clusters identified - coagulase-neg Staphylococcus epidermidis 4. Fevers - etiology unclear; symptoms consistent with (c/w) viral syndrome, unclear if related to vaccination." The subject was improving and could be followed by his primary care provider. The subject had another follow-up for Afib secondary to myopericarditis status post (s/p) SPV. The subject stated the symptoms (sx) significantly improved since discharge but still with sub-sternal CP with mild exertion. The subject continued MOTRIN, Dilt, ASA. On 21 days post-vaccination, the subject's ECG revealed NSR 78, PT 172, QRS 89, QT, 364. "A/P 1. Acute myopericarditis - secondary to SPV - Afib RVR; s/p discharge - doing well with mild residual pain; continue meds for 3 months; f/u at that time and will discharge if doing well. Discussed with command that the subject not eligible for deployment overseas until cleared with ECHO in 3 months. The subject cannot be placed on limited duty as this will not allow him to even participate in beach detachment. Limited duty written for 30 days. 2. Obesity - BMI over 30; limited exercise currently secondary to myocarditis." On 70 days post-vaccination, the subject had a cardiac rehabilitation consult with rationale: new evaluation enrollment start of cardiac rehab for male with recent admission for myopericarditis, who is on medical restrictions until f/u with cardiologist in 30 days. Cardiopulmonary rehabilitation to include exercise and education of home exercise for 10 minutes. Therapy to include multiple exercise modalities for 25 min. to increase cardiopulmonary fitness as well as upper and lower body strength. The subject's vital signs (VS) and O2 stats are monitored pre, during and post exercise. The subject tolerated exercise in 11-13 rep range without s/sx of exercise intolerance and plans to begin bike riding at home. His HR climbed to maximum heart rate % (MHR%) 85-90% for his age with good quick recovery to baseline HR. Follow-up with the cardiologist was pending. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 06 March 2012 via a third party query tool search on the VAERS database, under reference number 444561. The subject had received: a left arm ACAM2000 (lot number VV04003A), an intramuscular injection (dose 1) of rabies (manufacturer, lot number and indication unknown), and an injection (dose 7) of BIOTHRAX (Emergent, lot number FAV301). The subject had no medical history and no current illnesses. The subject's other medications and prior vaccinations were not reported. On 02 December 2011, the subject required an Emergency visit when he developed pericarditis with chest pain, electrocardiogram (EKG) changes, echocardiogram abnormalities, fevers, rigors, and systemic myalgias. The subject was hospitalized (dates not reported). The outcome was reported as recovered. Documents held by sender: None.