Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Burning sensation, Pain in extremity, Pruritus, Psoriasis
Clinical narrative: a rash on specific body parts; itchy and burning sensation; itchy and burning sensation; they are not sure if it is psoriasis or due to stress; She developed lesions/lesions at first appeared on her hand and then abdomen and then heels/She also has lesions on the top of her feet; The skin is peeling out.; the palm of her hand- it's peeling and is completely leaving a surface that is painful and burning.; This is a spontaneous report from a contactable Other HCP (patient). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number:  FL3180) at Arm Left at single dose for COVID-19 immunsiation on 08Aug2021 at 11:00 AM  (63-year-old at the time of vaccination).   Relevant history included diabetic which was diagnosed 20 years ago but she had been using the same medication for years. She was not allergic to anything. Relevant concomitant drug was unknown. The patient did not have prior Vaccinations (within 4 weeks).  A week after the vaccination, the patient developed a rash on specific body parts - She consulted a dermatologist and did a biopsy and the dermatologist told her it is a possible reaction to the vaccine, but was not sure.  She went to the ER and she was given an injection of steroids and cream. She stated they are not sure if it is psoriasis or due to stress. She developed lesions and then she mentioned it was itching and there was a burning sensation. The lesions at first appeared on her hand and then abdomen and then heels. She also has lesions on the top of her feet is what the caller described. The skin was peeling out. According to the caller, the lesions on her abdomen already healed but the new lesions on the top of her feet was concerning.  She had not received the 2nd dose yet as her doctor was unsure if they will recommend it due to her condition or if she could still have it until it has resolved.   She clarified the lesions she was concerned with was the ones on her hands. She needs her hands to work. The lesions on her hands never heal. Her skin was very itchy and burns. She clarified its on the inside of her hand, in the palm of her hand- it was peeling and was completely leaving a surface that was painful and burning. The caller clarified the lesions were a rash that peels. She had the rash/lesions in the back of her thighs going up, her feet and her hands right now, basically. The lesions that were on her trunk (belly/abdomen) have improved, they were not there anymore. The lesions have healed and its okay.  She clarified the lesions in her hands have persisted, the ones in her feet and thighs were new, so it was expanding. When probed for seriousness criteria, the caller states it has not required hospitalization, but it was serious. She needs her hands to work. She doesn't have any other medical conditions that she would consider this to be life-threatening. The caller clarified she would consider this to be medically significant since no one can tell her what it is.  She believed the rash/lesions to be related to the vaccine as there is no other clue as to what it could be.   She confirmed the Emergency Room injected her with steroids and a prescription for steroids. They could not relate anything to the vaccine and recommended she visit with a dermatologist. She confirmed she went to the dermatologist. She stated it been a month since she had been on steroids. She was a diabetic and could not be on steroids for that much time. She was looking for a treatment to solve this issue.    She had the biopsy, which was collected 30Aug2021 and reported on 09Sep2021. The outcome of event Psoriasis was unknown, the outcome of other events was not resolved.   COVID-19 vaccine: lesions/rash on specific parts of her body - Related.  No further information was provided or obtained.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event rash and suspect drug BNT162B2 cannot be excluded.  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.