Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash started to spread on the right leg/ rash still spread to the whole body/full body rash; allergic reaction to something; hives; Itching; random nerve pains; enlarged lymph nodes on both sides of the neck (Left lymph node is larger).; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 07Apr2021 at 14:30 (at the age of 55 years old; Lot Number: EW0151, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing reflux. Concomitant medication included pantoprazole for reflux since Dec2019.  The patient also received her first dose of BNT162B2 on 17Mar2021 at 14:30 in left arm (at the age of 55 years old; lot number: EP6955) for COVID-19 immunization and experienced small rash on the lower left leg/little red rash on her left lower shin and the rash developed into some really bad itching. The patient received her second dose on 07Apr2021 and after some time, the rash started to spread on the right leg. She went to an urgent care and was told that she was having an allergic reaction to something. The rash still spread to the whole body. The doctor asked her if she had been hiking and she said she hasn't hiked in 20 years. She had no changes to the food she's eating, no laundry changes. The urgent care doctor prescribed prednisone and an antibiotic. The rash didn't get better. The rash turned into a full body rash and hives. She does not know the name of the antibiotic. Both bottles or containers of the prednisone and antibiotic have been thrown away. After she finished the prednisone and antibiotic, she went to her primary care doctor and the doctor agreed the rash looked like an allergic reaction. The patient also experienced itching. She was sent to a dermatologist and was prescribed second antibiotic and a steroid topical oil which somehow helped relieve the rash. The rash is clearing up now, she's finally not itching. This has been going on for two months. She also stated random nerve pains and enlarged lymph nodes on both sides of the neck (left lymph node is larger). The dermatologist did take a skin specimen or skin biopsy from her lower left leg and her right arm about 2-3 inches above her wrist on 18May2021 with unknown results. Those areas were deeper than a skin scraping, those areas had to be sutured. She does not have any results from the skin biopsy. She's guessing on the timing of when the rash first appeared on her left leg, she would guess about a week after receiving the first COVID-19 vaccine. At that time, it was only on her left leg. She still thought it was just a mosquito or spider bite, she didn't think it was related to the COVID-19 vaccine. The rash on her left leg was still present when she received her second COVID-19 vaccine. About 24 or 36 hours after she saw the dermatologist, she had improvement in her rash. The patient was also prescribed doxycycline 100mg capsules, take one capsule twice a day for 30 days. The steroid oil is fluocinolone acetonide topical oil 0.01%.  Prior to her seeing the dermatologist the rash was spreading into a new area every day, it was almost full body, the rash was everywhere, every day there was more rash. Both doctors that she saw told her that the medication had nothing to do with her rash.  She saw her primary care on 12May2021. She saw the dermatologist on 18May2021. Her primary care doctor wanted her to follow up with some blood work after seeing the dermatologist. She has not followed up with her primary care doctor yet.  No vaccines administered on same date with the Pfizer vaccine. No prior vaccinations (within 4 weeks). The events resulted in physician office visit.  The patient was recovering from rash and allergic reaction; recovered from itching on unspecified date; while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. 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 RAs, Ethics Committees, and Investigators, as appropriate.