Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain, Product use issue, Pruritus, Urticaria
Clinical narrative: Large red hot hives; The hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful; The hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful; The hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful; Large red hot hives; Flulaval quadrivalent was administered on 22Sep2021; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Sep2021 (Lot number: FD0809) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT), administered in arm left, administration date 22Sep2021 (Lot number: 2579B) as dose 1, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; DEXTROAMPHETAMINE [DEXAMFETAMINE]; AMPHETAMINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 22Sep2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant), ERYTHEMA (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Large red hot hives"; FEELING HOT (non-serious), PRURITUS (non-serious), PAIN (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "The hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful"; PRODUCT USE ISSUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "Flulaval quadrivalent was administered on 22Sep2021". The events "large red hot hives", "the hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful", "the hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful", "the hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful" and "large red hot hives" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: allergy test: (2021) unknown results; blood test: (2021) unknown results; investigation: (2021) unknown results. Therapeutic measures were taken as a result of urticaria, feeling hot, pruritus, pain, erythema. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Two weeks after the booster on 09Oct2021, the patient developed large red hot hives and they have continued daily until this very day. Three months. The only new variable at the time was the booster shot. The last dermatologist the patient spoke with told that others have experienced the same. The hives appear for 24hr and go from small to large, raised, hot, itchy, and if itched - painful. There was no prolonged hospitalization. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Steroids, antihistamine were the treatment received for the adverse event and nothing worked. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.