Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash pruritic
Clinical narrative: rashes in the stomach/rash on her stomach and now has a full blown rash head to toe and/Rash: Serious. Very unsightly, unpredictable, and itchy.; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 26Jun2023, this case contains serious adverse reaction, and all safety information is processed together.   This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Feb2023 as dose 4 (booster), single (Lot number: GJ6665) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Urinary tract infection" (unspecified if ongoing). Concomitant medication(s) included: CEFUROXIME taken for urinary tract infection, start date: Feb2023, stop date: Feb2023; CIPRO [CIPROFLOXACIN] taken for urinary tract infection, start date: 20Feb2023; NITROFURAZONE taken for urinary tract infection, start date: Feb2023, stop date: Feb2023. Vaccination history included: BNT162b2 (Dose: 01, Lot Number: ER8731 had a hard time reading LOT on vaccine card.), administration date: 15Apr2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "feeling yucky"; BNT162b2 (Dose: 02, Lot Number: EW0199, NDC/EXPIRY: Not on vaccine card), administration date: 08May2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "feeling yucky"; BNT162b2 (Dose: 03, Lot Number: FD0809, NDC/EXPIRY: Not on vaccine card), administration date: 15Dec2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "feeling yucky". The following information was reported: RASH PRURITIC (medically significant) with onset 22Feb2023, outcome "not recovered", described as "rashes in the stomach/rash on her stomach and now has a full blown rash head to toe and/Rash: Serious. Very unsightly, unpredictable, and itchy. ". It was reported that the patient started breaking out rashes in the stomach and that this has been going on for four months. The patient was then prescribed prednisone and that all her blood work results turned out normal. Mentioned that the patient has already talked to all the doctors but thought that it was a side effect from the vaccine. Also stated that she would wake up totally clear and after five minutes of walking, her rashes will start to appear. The patient wanted to know if there were similar reports to this and if there is any relevant information to what she is experiencing now. Further stated that the patient started getting rashes on her stomach and now has a full-blown rash from head to toe and has been to her doctors. The doctors have done every blood test imaginable, and all the patient's numbers were coming back fine. The doctors thinks that the rashes were a side effect of the booster. The patient has an appointment with an allergist to do allergy testing. There is nothing different about her environment now and everything is pointing to the booster. The patient mentioned that the side effect has been going on for four months already. The patient has been prescribed prednisone by the HCP to address the rash. The rash was described as serious, very unsightly, unpredictable, and itchy. It as been staying the same, and over the last two weeks, it has gotten worse. It used to come and go throughout the day. Rash would be clear when she woke up then 15 minutes later would break out and be covered and then the rash would go away during the evening time. But now she wakes up with no rash and 10 to 15 minutes later breaks out, then the rash goes away for 2 hours, then comes back, then goes away and an hour later comes back. There is no rhyme or reason or anything triggering the rash. It was unpredictable. The patient was also on ciprofloxacin due to urinary tract infection but discontinued after a day and a half because she broke out in a rash and thought that it was an allergic reaction to ciprofloxacin. Stated that Nitrofurazone was started probably around 08Feb2023 or 09Feb2023 for 5 days. The events "rashes in the stomach/rash on her stomach and now has a full blown rash head to toe and/rash: serious. very unsightly, unpredictable, and itchy. " required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (2023) All her numbers are coming back fine; (2023) Normal, notes: all her blood work results turns out normal. Therapeutic measures were taken as a result of rash pruritic.; Sender's Comments: Based on temporal association, the event rash pruritic is possibly related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). 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.