Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram QT prolonged, Electrocardiogram ST-T segment abnormal
Clinical narrative: This case was received on 23 June 2011 via a third party query tool search on the VAERS database, under reference number 420793. A 26-year-old male patient with a history of tobacco use, received a right arm injection of ACAM2000 (lot number VV04003) on 22 March 2011. On 01 April 2011, 10 days post-vaccination, he experienced an onset of chest pain which he attributed to smoking. However, after 3 days of tobacco cessation the chest pain continued, and the patient presented to the urgent care clinic on 04 April 2011. Laboratory investigations revealed elevated Troponin 1 and diffuse ST elevation on ECG. The patient was hospitalized, and the event was ongoing at the time of the report. Follow-up information was received on 26 January 2012 from the investigator. This case was determined to be a duplicate report of study case number 2011-10513. Case 2011-03775 will remain the case of reference and will be updated by adding the coded events and with information previously captured in case 2011-10513 (which will be subsequently deleted from our safety database). The following information is verbatim from case 2011-10513: This study case was received from the investigator in trial on 28 October 2011. A 26 year-old male subject with a medical history of high blood pressure was found to have an unspecified disease of the pericardium 23 days after he had received on 22 March 2011 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I (highest recorded value not reported) and an abnormal ECG on 04 April 2011. On 18 April 2011, the subject had an abnormal echocardiogram. On 08 June 2011, the subject had a normal MRI of the heart. A lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Follow-up information was received on 22 October 2012 from the investigator. On 04 April 2011, 13 days post vaccination, the subject was diagnosed with pericarditis. The subject presented with sudden onset of chest pain for four days, which was substernal, non-radiating, sharp, constant, and increased when patient lied down and was not relieved by non-steroidal anti-inflammatory drugs (NSAID's). Subject complained of shortness of breath, nausea, and was febrile. 13 days post vaccination, the electrocardiogram (ECG) results showed diffuse ST elevation of acute pulmonary disease. 15 days post vaccination, the echocardiogram showed hyperkinesis,akinesis, IVC dilation positive, pericardial effusion, ejection fraction 64%, left ventricular function normal, and the electrocardiogram showed normal sinus rhythm, R axis deviation, ST and T were abnormality, prolonged QT and abnormal ECG. The Troponin 1 level was positive (H) with controls acceptable. Hospital admission lasted 8 days. The subject was diagnosed with persistent pericarditis and continued to by symptomatic. The subject's outcome was not recovered. Documents held by sender: None.