Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Heart rate increased, Heart rate irregular, Infusion, Palpitations
Clinical narrative: Test revealed asymmetric septal hypertrophy; thickening of heart muscle wall; palpations; chest heaviness; shortness of breath; A-Fib with RVR; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 58-years, on 13Aug2021 08:00 (Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, GERD, Seasonal Allergies, Basal Cell skin cancer. Concomitant medications included montelukast; cetirizine; omeprazole and budesonide, formoterol fumarate (SYMBICORT); all taken for an unspecified indication. There was no other vaccine received in four weeks. The patient previously took NSAIDS and doxycycline and experienced allergies. The patient experienced test revealed asymmetric septal hypertrophy and thickening of heart muscle wall on 17Aug2021; and experienced palpations, chest heaviness, shortness of breath and A-Fib with RVR all on 16Aug2021 13:00. Above adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and Life threatening illness (immediate risk of death from the event). The patient was hospitalized for above events from 16Aug2021 to 17Aug2021 for one day. Therapeutic measures were taken included EKG, bloodwork, echocardiogram and medications as reported. There was no Covid prior vaccination or Covid tested post vaccination. The events outcome was recovered.  The clinical course was reported as follows: 16Aug2021 went to ED for palpations, chest heaviness, shortness of breath. EKG revealed A-Fib with RVR. No previous history. After 5 hours in ED, converted to normal sinus rhythm with Cardizem IV drip. Cardizem drip stopped and placed on by mouth. Heparin drip started. Spent night in hospital and had echocardiogram next morning (17Aug2021). Test revealed asymmetric septal hypertrophy, thickening of heart muscle wall. Discharged on diltiazem and apixaban. PCP said was due to vaccine and after a few months with no events, will be able to discontinue medications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cardiac septal hypertrophy, hypertrophic cardiomyopathy, palpitations, chest discomfort, atrial fibrillation and dyspnea cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.