Age: 30.0
Sex: M
Vaccine: MMR, RAB, SMALL
Symptoms: Ejection fraction decreased, Electrocardiogram QT prolonged, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Electrocardiogram ambulatory normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 17 April 2015. A 30 year-old male subject whose past medical history included high blood pressure and cardiomyopathy was found to have hypertrophic obstructive cardiomyopathy on 13 March 2015, 23 days after the subject had received the following vaccines on 18 February 2015: an injection of Smallpox (Vaccinia) Live Vaccine, (number, route and site of administration not reported), Rabies Vaccine (reported as Rabbies - IM (4)), (manufacturer, lot number, route and site of administration not reported), and MMR (2) (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal ECG (electrocardiogram) on an unreported date. Troponin I, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. An ECG on 27 February 2015 was abnormal. Treatments were not reported. Adjudication Follow-up Report. 9 Days Post Vaccination. Outpatient Visit Patient with history of murmurs presented for a cardiac examination. Labs and CXR were normal but abnormal EKGs showed inverted T-wave activity. Recommend cardiac evaluation. CXR - (Normal) PA/LAT shows satisfactory inspiration with no evidence of active pulmonary disease. The cardiac silhouette is normal with no evidence of enlargement and mediastinum, great vessels, pleura, diaphragm, and bony thorax are unremarkable. EEG1 - (14:20) Sinus bradycardia with sinus arrhythmia, rightward axis, and T wave abnormality with QT-QTc = 432/427ms EEG2 - (14:22) NSR, sinus arrhythmia, rightward axis, and T-wave abnormality with QT/QTc = 420/446ms EEG3 - (14:24) NSR with left posterior fascicular block, T-wave abnormality, and QT/QTc = 422/471ms. 23 Days Post Vaccination Cardiology Visit Patient has history of LVH without evidence of HOCM on stress ECHO done on April, 2014. A/P - Cardiomyopathy hypertrophic with an IVSD = 1.6 and mild SAM without outflow tract obstruction (mean gradient = 4 mmHg). 30 Days Post Vaccination. Cardiology Visit Chief compliant is evaluation of hypertrophic cardiomyopathy. ECHO demonstrated hypertrophic cardiomyopathy with LVEF = 55% and septal wall = 1.8 cm. Left atrium was mildly enlarged at 4.3 cm, myocardial perfusion study with an anteroseptal fixed detect and an LVEF = 53%. No hypotension and/or drop in BP noted on the treadmill test. Patient remains asymptomatic with no SOB, chest pain, or syncope. 33 Days Post Vaccination. Outpatient Visit Patient was screened for cardiovascular disorders. Holter monitor was unremarkable with no episodes of non-sustained ventricular tachycardia. 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.