Age: 61.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Type 2 diabetes mellitus, White blood cell count increased
Clinical narrative: Initial solicited report received on 23 May 2016 from an investigator participating in a study. This case involves a 61-year-old male subject who had heart attack and car accident during the study participation. Medical history was not relevant on record and there were no concomitant medications on record. On 02 May 2016, 10 days after receiving a single dose of blinded therapy 2.5 mcl on 22 April 2016 (route and site of administration were not reported; batch number: VV-03-011-C and expiry date: 17 May 2016), the subject had heart attack and car accident. The event appeared after visit was not reported. Prior to study participation, the subject was a regularly attending plasma donor at the site since 28 July 2015. The subject was screened for participation in study protocol on 19 April 2016. There were no abnormalities found during the subject's physical exam. The ECG showed normal sinus rhythm flat T waves in lead I, aVL and V2-V6 considered by the cardiologist as abnormal electrocardiogram (ECG) but insignificant. The set of labs as per standard to protocol and the physical examination during screening were reviewed on 21 April 2016 and considered acceptable by the primary investigator for enrollment. The subject was vaccinated after undergoing a second physical exam and basic cardiopulmonary assessment during the same visit. There were no abnormal findings during these exams on this day. The subject was seen at this site for day 3 post-vaccination site check on 25 April 2016 and underwent a basic cardiopulmonary assessment. This was the last contact this study site had with this subject. On 17 May 2016, after noticing that the subject had missing 3 visits, the site attempted to contact the subject; the subject's roommate answered the phone, who in turn notified of the subject's death. The roommate said that the subject had a heart attack while driving 02 May 2016. The subject was transported to an emergency room via ambulance and was admitted to an undisclosed inpatient wing of the hospital. It was currently unknown if the heart attack preceded the motor vehicle accident or if the motor vehicle accident preceded the heart attack. The subject was declared deceased on 05 May 2016. No other information was available at this moment. The principal investigator had considered that the heart attack and the motor vehicle accident are "unassessable" as the information was limited; reason for which he requested additional information from the treating hospital. The approval for the release of the subject's medical records was pending until the subject's death certificate had been issued from the coroner's office. Basic cardiopulmonary assessment showed no abnormal findings at day 03 post-vaccination. Other lab data was recorded before vaccination and event onset. The corrective treatment were not reported. The outcome of the events heart attack and car accident was fatal and the subject died on 05 May 2016. According to the investigator, at the time of report the information was inconclusive to properly assess the case. Relationship to investigational product according to Company: not associated. The information whether the serious adverse event led to the termination of the subject from the study or not, was not reported. List of documents held by sender: none. Sender's Comments: A 61-year-old male subject died 10 days after receiving a dose of ACAM2000 vaccine due to myocardial infarction and car accident. It was not clear which event preceded the other. Details of Autopsy and death certificate were not reported at the time of this report. Based on limited data available, the sponsor assesses this event as not related to study vaccine or procedure in agreement with the investigator. Reported Cause(s) of Death: myocardial infarction; road traffic accident.