Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Electroencephalogram, Headache, Heart rate
Clinical narrative: witnessed syncopal episodes, in which a rapid response was called.; approximately 20 minutes after vaccination she began to feel heart palpitation and checked her HR which was 156bpm; lightheadedness; chest pressure; nausea; vomiting; headache; generalized itchiness; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received second dose of BNT162B2 (BNT162B2), intramuscular on 17Sep2021 11:15 (Batch/Lot Number: EW0191) as DOSE 2, SINGLE for covid-19 immunization. Medical history included ASCUS of cervix with negative high risk of HPV, Alopecia, near syncope (since age 26), pelvic floor pain, heart palpitations (since age 26) and tachycardia (since age 26). Concomitant medications included vitamin d3 (VITAMIN D3), etonogestrel (NEXPLANON) and omeprazole (OMEPRAZOLE) all taken for unspecified indications, start and stop dates were not reported. The patient experienced witnessed syncopal episodes, in which a rapid response was called approximately 20 minutes after vaccination she began to feel heart palpitation and checked her hr which was 156bpm, lightheadedness, chest pressure, nausea, vomiting, headache and generalized itchiness all on 17Sep2021 at 11:15. The event witnessed syncopal episodes, in which a rapid response was called was reported as medically significant. It was reported that she began to feel heart palpitations and checked her hr which was 156bpm, also had lightheadedness and chest pressure, followed by witnessed syncopal episodes, in which a rapid response was called. No seizure activity noted. When she awoke, she developed nausea/vomiting, headache and generalized itchiness. Denies any lip or facial swelling or difficulty breathing. No reaction or problems with initial covid vaccine. Patient was in normal state of health this morning, no recent illness. Patient does not have history of syncope but does have history of near syncope, heart palpitations and tachycardia since age 26. Has had extensive work up in past including holter monitor, loop recorder, EEG and diagnostic ablation procedure to evaluate for SVT without intervention. Work up has all been essentially negative. AE resulted in: Emergency room/department or urgent care. AE treatment : Ondansetron 4mg x 1 dose. The patient underwent lab tests and procedures which included EEG (electroencephalogram): unknown results on an unspecified date and HR (heart rate): 156bpm on 17Sep2021. Therapeutic measures were taken as a result of witnessed syncopal episodes, in which a rapid response was called, approximately 20 minutes after vaccination she began to feel heart palpitation and checked her hr which was 156bpm, lightheadedness, chest pressure, nausea, vomiting, headache and generalized itchiness. The patient received first dose of Comirnaty on 25Aug2021 at 10:00 am (lot number EW09191) intramuscular. The outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Syncopal attack.  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