Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Developed a very red, very itchy rash on my chest/I got the 2nd dose and the rash was still on my body, arms, legs; Developed a very red, very itchy rash on my chest; Developed a very red, very itchy rash on my chest; It has all sorts of discoloration and flakiness; It has all sorts of discoloration and flakiness; Skin is mottled; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose on 27Jan2021 (Lot Number: EL3249) and second dose on 17Feb2021 (Lot Number: EL9264), both via an unspecified route of administration, administered in Arm Left at the age of 81-year-old as single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included other medications (unspecified), medication (unspecified) for blood pressure. He took other medications and never had a rash with them. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any prior Vaccinations (within 4 weeks). The patient had no AE(s) following prior vaccinations. The patient previously took cefalexin (KEFLEX) and also Sulfa drugs and had a rash. It had been several years ago. Family medical history relevant to AE(s) was not provided. Caller states he received his 1st Pfizer Covid vaccine on 22Jan2020 (as reported) and his 2nd vaccine in February. Caller states 5 days after his 1st shot he developed a very red, very itchy rash on his chest. The patient went to urgent care, not the ED and got a Medrol Injection and a 7-day pack of prednisone. The rash continued and he got the 2nd dose and the rash was still on his body, arms, legs, he went to urgent care and got a Decadron injection and another 7 days of prednisone. The rash was better but still reoccured daily somewhere on his body arms, legs. His skin was mottled and it looked like he was beat up. The patient enquired if he should get the Moderna booster shot instead of Pfizer, since he still had this rash. Spoke to caller from the attached documents. He had the Pfizer COVID Vaccine, two doses. The first one was on 27Jan2021 and the second was on 17Feb2021. After he had the first dose, a week later, he had a reaction. He is sure it was due to the vaccine. He got a rash on his chest similar to a rash when he took an antibiotic in Feb2021. It was an itchy, red rash. He talked to the local people giving the vaccine and they recommended he still get the second dose even though the rash was going on. He went to a medical facility. He had been there before. They gave him an injection of Medrol and seven days of Medroxy Prednisolone tablets. That helped a lot, but then he got the second shot. He continued to have itchy rashes all over his body. He went back to the medical facility and they gave him a dose of Decadron steroid and another seven day package of Prednisolone. He called a dermatologist that he saw a couple of years ago. He couldn't get caller in and caller had a feeling he didn't want to deal with it. Caller got an appointment with another dermatologist and went to the office. He was seen by a PA. She took a paper out of the file cabinet and told him to not use dryer sheets and change detergents. He saw the PA with the dermatology practice in May2021. The appointment was around 10May2021. Caller clarified that it was not Medroxy Prednisolone it was Methylprednisolone that he took. He took Methylprednisolone both times for seven days. He kept the package. It was a 4mg tablet. Lot number: 20P0432. Expiry: May2022. Date filled was 05May2021, so the visit to the dermatologist was on the 10May2021. Caller clarified the product information for the Methylprednisolone was for the second seven day course that he took.  Caller clarified that he does not have NDC, lot, and expiry to provide for the first seven day course of Methylprednisolone that he took.  It was the one that starts with six tablets the first day at breakfast, lunch, and supper. Then he decreased it by one each day. So the second day it was five, then four, then three, and then one. It was a total of 21 tablets. Rash was not so bad today (26Aug2021), it was ongoing. It was different parts. Sometimes both legs would be itchy and then his back would be itchy. A lot of times it was in the legs. Here he was in September and periodically he still gets an itchy rash on different parts of his body. His skin looks like he had been in a battle. It had all sorts of discoloration and flakiness. He was concerned about taking the booster the shot. Caller confirmed he is looking for information about the booster shot with having rash after the first and second dose of Pfizer COVID Vaccine. The AE(s) did not require a visit to Emergency Room. The patient had Physician Office visit, he was seen at Urgent Care because they have open convenient hours and at the Dermatologist. They didn't do any test or bloodwork at the Urgent Care. Reporter assessed the event Rash as Medically significant. He takes other medications and never had a rash with them. The reporter assessed the reaction Rash as related to the vaccine. Outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events rash, rash erythematous, rash pruritic 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.