Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure systolic, Dizziness, Erythema, Hypotension, Pruritus
Clinical narrative: short period of low blood pressure; itching in her hand and fingers; both hands turned bright red/her face, chest, and neck turned bright red; lightheaded and dizzy; This is a spontaneous report from contactable physicians (one is patient's husband). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), dose 1 intramuscular on 06Mar2021 11:00 (at the age of 69years) as dose 1, 0.3 mL, single for Covid-19 immunization. Medical history included diffused thyroiditis and radioactive treatment, radiation treatment. Concomitant medication included thyroid (ARMOUR THYROID) taken for thyroid disorder from an unspecified start date and ongoing (since she was in her early 40s, taking about 25 or more years). Historical vaccine included flu vaccine on an unspecified date (at the age of 69years) as immunization; where the patient had trouble (Had trouble with flu vaccine and found out it had to do with one of the stabilizing ingredient thimerosal. Then she has had a flu vaccine without that ingredient and did not have a reaction). It was reported that the patient received the first dose of the vaccine on 06Mar2021 and experienced a significant reaction. The patient's reaction started at minute 37 after the shot. Left site about 3 and half to 4 hours after the shot. It was recommended for her to go to the ER (emergency room) but she did not go. The reaction was described as started with itching in her hand and fingers, then both hands turned bright red, her face, chest, and neck turned bright red, got itchy in those various places, she was lightheaded and dizzy. EMT/nurses took her blood pressure and she had a short period of low blood pressure where her systolic was around 70. Treatment offered was Benadryl, but she cannot take it with colored dye, so she took a dye free Benadryl about 10 or 15 minutes after the reaction. She was still not feeling quite right during the hour and half drive to get home, not quite right at home and weak. A day or two later she recovered completely. The reporter reported having talked with their HCP, the CDC, and an allergist. HCP and CDC recommended not to get the second dose; the allergist alluded to a study by describing that the majority of people who received the second dose after having a reaction after the first were okay. This allergist prescribed caller's wife medication, including a steroid, Zyrtec, and an EpiPen to mitigate the potential reaction if patient does receive the second dose. There reporter added that they have contacted many clinics, pharmacies, and doctors to see if they will administer the second dose to patient; they all said, "they would not give the shot". The outcome of event short period of low blood pressure was unknown; outcome of other events was recovered in Mar2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pruritus, erythema, dizziness and hypotension and BNT162B2.  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.