Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
a very bright red rash all over face and down both arms/rash was very red and itchy; a very bright red rash all over face and down both arms/rash was very red and itchy; allergic reaction to the Pfizer Covid 19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left lower forearm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: QSYMIA oral taken for weight decreased, start date: Sep2024 (ongoing); OMEPRAZOLE oral taken for dyspepsia (ongoing); MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] oral taken for prophylaxis (ongoing); CITRACAL [CALCIUM CITRATE] oral taken for bone disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL5262), administration date: 23Jan2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EN6201), administration date: 13Feb2021, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Lot: Has two numbers, FM0698, WAG12853), administration date: 28Mar2022, for Covid-19 immunization; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), administration date: 2023, for Covid-19 immunization; Bnt162b2 nos (DOSE 5 (BOOSTER), SINGLE), administration date: 2023, for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), administration date: Mar2024, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset 05Apr2025, outcome "recovered" (Apr2025) and all described as "a very bright red rash all over face and down both arms/rash was very red and itchy"; HYPERSENSITIVITY (non-serious) with onset 05Apr2025, outcome "recovered" (Apr2025), described as "allergic reaction to the Pfizer Covid 19 vaccine". Therapeutic measures were taken as a result of rash pruritic, rash erythematous, hypersensitivity. Additional information: patient had allergic reaction to it, had Pfizer Comirnaty on 04Apr2025. Clarified the reaction patient had been a very bright red rash all over face and down both arms. This was the first one patient ever had an allergic reaction to for the COVID shots. Patient always had Pfizer COVID shots except on one occasion when patient had Moderna COVID shot. Went to the doctor on 06Apr2025 since it was a weekend and was given prednisone and Benadryl. Rash didn't show up until the next day, 05Apr2025, and the rash didn't go away until the last day of the medications, which was about 10 days later. Patient with a question, didn't know if had any advice regarding whether or not patient should take another COVID shot or not take another Pfizer COVID shot or anything like that. patient can't think of more details. patient worked in a health office, clarified patient was not an HCP, the caller was an administrator. Bright red rash all over face and down both arms: Rash didn't show up until the next day, 05Apr2025, and the rash didn't go away until the last day of the medications, which was about 10 days later. Stop date, outcome: Confirmed rash is not ongoing, recovered completely. Concomitant products: Just regular medications, patients then provided information in formal fields from pill box. Patient and patient's husband couldn't think of the name of the multivitamin patient takes; patient then clarified it is Centrum multivitamin. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
QSYMIA; OMEPRAZOLE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR; CITRACAL [CALCIUM CITRATE]