Age: 61.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood sodium normal, Bradycardia, Carbon dioxide decreased, Cardiac arrest, Condition aggravated
Clinical narrative: On 17MAY2016, a report was received from study was received from a study site indicating that subject experienced a heart attack, motor vehicle accident and death. Patient was a 61 year old male, subject who was vaccinated with ACAM2000 on 22APR2016 (2.5 ul, Lot # VV-03-011-C, expiry date 2016-May-17) as part of the study. Prior to study participation, the subject was a regularly attending plasma donor at the site since 28JUL2015. Medical history was not relevant and on record, there were no concomitant medications on record. The subject was screened for participation in study protocol on 19APR2016. 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 ECG but insignificant. The set of labs as per standard to protocol and the physical examination during screening were reviewed on 21APR2016 and considered acceptable by the primary investigator for enrollment. The subject was vaccinated on 22APR2016 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 25APR2016 and underwent a basic cardiopulmonary assessment. There were no abnormal findings during this exam on this day. This was the last contact this study site had with this subject. On 17MAY2016, 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 02MAY2016. The subject was transported to an emergency room via ambulance and was admitted to an undisclosed inpatient wing of the hospital. It is currently unknown if the heart attack preceded the motor vehicle accident of if the motor vehicle accident preceded the heart attack. The subject was declared deceased 05MAY2016. No other information is available at this moment. The principal investigator has considered that the heart attack and the motor vehicle accident are "Unassessable" as the information is limited; reason for which he has requested additional information from the treating hospital. The approval for the release of the subject's medical records is pending until the subject's death certificate has been issued from the coroner's office. Comment: Subject had no known allergies. Support (amiodarone, epinephrine and dopamine to keep MAP above 65 mmHg and a heart rate above 60 bpm). However, the subject was in critical condition and deteriorating and by 27APR2016, he developed acute kidney injury (creatinine increased from 1.4 up to 1.7 mg/dL) associated with hypokalemia (potassium as low as 1.8 mEq/L). The subject also was hyperglycemic with glucose up to 686 mg/dL believed to be due to type II diabetes mellitus and metabolic acidosis. On 28APR2016, the subject was bradycardic; the LVEF was 15-20%. While he was in the ICU, the patient developed another cardiac arrest. Resuscitation attempt was limited to 10 minutes as per family request. Despite 3 doses of epinephrine and 1 dose of atropine and chest compressions, there was no return of circulation. The patient passed away at that time. The investigator considered these events unlikely related to ACAM2000. Comment: Subject had no known allergies.