Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy; painful; full body dermatitis rash with hives (urticaria); full body dermatitis rash with hives (urticaria); difficult to perform normal life activities; difficult to perform normal life activities; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 18:30 as dose 4 (booster), single (Lot number: 6H9694) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "migraines" (unspecified if ongoing); "menstrual irregularity" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (Pfizer COVID-19 1st Booster, Dose Number: 3, is bivalent=False, Batch/Lot No: Pfizer FF2890), administration date: 09Oct2021, when the patient was 31-year-old, for COVID-19 immunization; BNT162b2 (Pfizer COVID-19 2nd Dose, Dose Number: 2, is bivalent=False, Batch/Lot No: Pfizer ER8732), administration date: 30Mar2021, when the patient was 30-year-old, for COVID-19 immunization; BNT162b2 (Pfizer COVID-19 1st Dose , Dose Number: 1, is bivalent=False, Batch/Lot No: Pfizer EN6206), administration date: 09Mar2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (medically significant) with onset 25Sep2022 at 06:00, outcome "not recovered", described as "Itchy"; IMPAIRED QUALITY OF LIFE (medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) all with onset 25Sep2022 at 06:00, outcome "not recovered" and all described as "difficult to perform normal life activities"; DERMATITIS (medically significant), URTICARIA (medically significant) all with onset 25Sep2022 at 06:00, outcome "not recovered" and all described as "full body dermatitis rash with hives (urticaria)"; PAIN (medically significant) with onset 25Sep2022 at 06:00, outcome "not recovered", described as "painful". The events "itchy", "painful", "full body dermatitis rash with hives (urticaria)" and "difficult to perform normal life activities" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pruritus, pain, dermatitis, urticaria, impaired quality of life, loss of personal independence in daily activities.  Clinical course:Itchy and painful, full body dermatitis rash with hives (urticaria). Patient has gone to emergency room and further doctor visits to treat. Persistent and resulting in difficult to perform normal life activities. Anti-histamine and steroid medicines not providing relief. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination.The patient had received Prednisone, Hydroxyzine, Benadryl, Steroid creams as treatment for events. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. There were no known allergies.; Sender's Comments: Based on available information, a possible contributory role of BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)cannot be excluded for the reported events of Pruritus, Pain, Dermatitis, Urticaria, Impaired quality of life, Loss of personal independence in daily activities. 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.