Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; she was a little bit red; blood pressure lowered a little bit; This is a spontaneous report from a Pfizer sponsored Program . A contactable Physician reported for herself that. A 65-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Feb2021 15:00 (Batch/Lot Number: FL9267) as SINGLE DOSE for covid-19 immunisation (Age at vaccination was 64 years). Medical history included immunocompromised and she is a very allergic person and can treat allergies. Concomitant medications were not reported. On an unspecified date patient experienced horrible hives and hoarseness and itching, she was a little bit red and blood pressure lowered a little bit. It was reported that after the 1st dose of the Pfizer COVID Vaccine, it seems like she was a little bit red and she did not pay much attention to it then at night on the 2nd day and that night became horrible hives and hoarseness and itching; caller states these symptoms are not ongoing and lasted about 4-5 days; states the 2nd day the hives started at night about 24 hours over. Caller states then the symptoms disappeared and she used an antihistamine Benadryl and every time she takes it is 50mg and she then used Zyrtec 10mg and only used the Zyrtec twice and had terrible side effects from the Zyrtec and did not like it and prefers the Benadryl; no further details provided by the caller. Caller states because she was an allergic subject, she always has Benadryl at home. the first night after she had the Pfizer Covid vaccine, she had her epipen with her but was following her blood pressure and pulse and the blood pressure lowered a little bit but not terribly and the pulse was the maximum of 99 so she decided not to go to the emergency room and she stayed home and did not do the epipen; states she decided to stay home and monitor herself but she was ready to go to the emergency room if needed and by 9:00pm she seemed fine and only her blood pressure had slowed a little bit and her pulse at one time went to 99 and she did not do the epipen; despite further attempts at clarification, the information is captured as stated by the caller. Caller states the 2nd dose (lot number EN6204) was administered on 13Mar2021 around 12:00pm. The patient underwent lab tests and procedures which included blood pressure measurement: lowered a little bit, heart rate: maximum of 99 on, sars-cov-2 antibody test: negative on 29Mar2021. Reporter seriousness for antibody test that was done came back negative was Medically significant. Outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association.  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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.