Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Myocardial oedema, Myocarditis
Clinical narrative: Case number PHHY2014US078866, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529064) website on 25 Jun 2014, with the follow-up information received from Quality Assurance Department (reference number: 309493) on 30 Jun 2014. This report refers to 57-year-old male retiree patient. He had a 5 year history of hypertension, history of obstructive sleep apnea (OSA), allergic rhinitis, and first degree heart block noted in 2010 and history of precancerous growth on ear. Patient had a history of vertigo during the past 3 years thought to be consistent with benign positional vertigo (BPV). He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating. Patient reported vague history of URI symptoms during the previous month. He was in his usual state of health on 05 Feb 2014. He was vaccinated with FLUCELVAX (batch number: 007021A) intramuscular into right arm on 05 Feb 2014. He also received BOOSTRIX (batch number: 2RY59) into right arm following a routine physical. When he returned for a blood pressure check on 07 Feb 2014, an irregular heart rate was noted. At the time, patient was asymptomatic and an electrocardiogram (ECG) completed did not show significant changes from a 2010 ECG. Patient was referred for a 24 hour Holter which was completed on 19 Feb 2014. During the course of the Holter, cessation of ventricular activity was up to 6 seconds was noted and tracings were consistent with high degree atrioventricular block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted P-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6 day hospitalization, patient had normal echocardiogram and computer tomography (CT), cardiac angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac magnetic resonance imaging (MRI). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (Results not reported). On 20 Feb 2014, he exercised for 21 minutes and 2 seconds. (Results not reported). ECHO conclusions reported that this was a directed study for the evaluation of LV function. Overall LVSF was normal with an EF estimated between 60-65 percentage with no wall motion abnormalities. On 21 Feb 2014, Cardiac MRI: MRI findings consistent with myocarditis with 2 of 3 positive criteria (focal subpericardial abnormal late GAD enhancement in the basal to mid anterolateral wall with focal myocardial edema in a similar distribution). Normal LV size and mildly dilated. On 24 Feb 2014, a pacemaker was implanted. When patient was discharged on 25 Feb 2014, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. The outcome of the event was condition unchanged and causality assessment was not reported. Follow-up information received from Quality Assurance Department (reference number: 309493) on 30 Jun 2014: Product recoded from FLUVIRIN to FLUCELVAX and QA reference number.