Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy, Blister, Pruritus, Urticaria
Clinical narrative: Symptoms actually got progressed and worsened over time to blisters that actually weeping; He diagnosed the patient with an autoimmune response to the first dose; Developed hives on her trunk and her legs and they were very itchy/Hives did progressed to soles of her feet, top of her hands, her back, her legs; Developed hives on her trunk and her legs and they were very itchy; This is a spontaneous report from a contactable Nurse.   An 82-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6207 and Expire Date: Mar2021) via unspecified route of administration in arm (side unknown) on 17Mar2021 as dose 1, single for Covid-19 immunisation. The patient medical history included melanoma. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether any other medications the patient received within 2 weeks of vaccination. The patient has never had allergic reaction to any type of vaccine in the past or medications. On 24Mar2021, the patient was diagnosed with an autoimmune response to the first dose and prescribed oral steroid treatment. The patient developed hives on her trunk and her legs, and they were very itchy on 24Mar2021. She went to her primary health care physician who recommended Benadryl. The symptoms got progressed and worsened over time to blisters that weeping on an unspecified date. She went to a specialist, a dermatologist, who did biopsy of the blisters however reporter did not have the results of any biopsy, but the dermatologist indicated that she probably has an allergic type reaction to one of the chemicals in the vaccine, one of the ingredients. It was recommended to her by her MD not to get the 2nd dose. It started out initially only on her trunk and her legs after getting the first dose but then it progressed to blisters and then the hives further progressed to other body part, so it was over a week. Progressed more like blisters and itching. After she went to the dermatologist, the hives progressed to soles of her feet, top of her hands, her back, her legs. She continued treatment with Benadryl and topical treatment (unspecified medication) to the skin which really has not helped but the hives as of now were resolving, so has not fully gone away. It was resolving but not resolved yet. The patient revisited her physician and he advised her to seek an allergist's opinion. The allergist determined that the patient did not experience an allergic reaction to the first Covid vaccine. She underwent lab test which included biopsy of the blisters with unknown results on an unspecified date. Device date was reported as 24Mar2021. The outcome of event for autoimmune disorder, hives and itchy was recovering and for blisters it was unknown.; Sender's Comments: The causal association of reported events autoimmune disorder and urticaria in relation to suspected drug  bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine cannot be excluded based on temporal association in relation to vax schedule ans symptom presetnatation.  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