Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Feeling abnormal, Hepatitis B antibody positive, Hepatitis C antibody positive
Clinical narrative: Initial report was received from a healthcare professional who works for the health authorities on 08 October 2013. A 23-year-old male patient received an injection of ACAM2000 (lot number, route and site not reported) on 24 September 2013 and an injection of Anthrax Vaccine (manufacturer, lot number, route and site not reported) on 16 September 2013. On 06 October 2013, the patient presented to the emergency department (ED) with complaints of acute onset of shortness of breath, cough and feeling terrible which started that morning. The patient was worked-up in the ED and was consistent with hypoxia, which resolved with oxygen via nasal cannula, leukocytosis and chest CT consistent with atypical infectious process (bilateral linear opacities throughout right lung and lower left). He also had positive troponins x 3, abnormal ECG with reduced ejection fraction but cardiac MRI was negative for acute findings (including pericarditis). He was ruled out for pulmonary embolism and deep vein thrombosis. Labs also included positive for Hepatitis B IgM (0.1) and Hepatitis C antibody. The reporter referred to this as a potential case of myocarditis. Outcome was not reported. Follow-up information was received on 07 January 2014 via a third party query tool search on the VAERS database, under reference number 509899. The lot number of ACAM2000 was VV04003A. The patient also received a dose 4 FLUMIST QUADRIVALENT (Medimmune, lot number BJ2012) via the intranasal route on 24 September 2013. The patient was admitted to the hospital on 06 October 2013 with post-vaccine myocarditis. The patient had elevated CPK (creatine phosphokinase) and troponin and a decreased ejection fraction. Other medications, current illnesses and history were reported as none. Outcome was recovered. Upon internal review on 11 March 2014, it was determined that this event had also been captured in case 2014SA005436, and that this patient was actually a subject in a study. All information from both cases will be combined; 2013SA101784 will be kept as the case of reference, and 2014SA005436 will be deleted. The following information was received from the investigator on 14 January and 26 February 2014: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal, quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not availalbe. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter cauasality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received from the investigator on 26 February 2014. the subject had also received on 16 September 2013, Anthrax vaccine (manufacturer, lot number and anatomical site of administration not reported). On 06 October 2013, Troponin I result with abnormal with highest record value of 21.32 and an abnormal ECG. Treatments were not reported. The subject's outcome was not reported. Documents held by sender: None.