Received Mar 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
developed a non-serious event "blisters"; issue with itching and rash; issue with itching and rash; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2026SA037737 (SANOFI), AE-022783 (BioNTech). An elderly female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Lot number: 5F772A, Expiration Date: 31Mar2028) at 300 mg single (300 mg, single, every other week), subcutaneous for dermatitis atopic. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN 81. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "developed a non-serious event "blisters""; PRURITUS (non-serious), RASH (non-serious), outcome "unknown" and all described as "issue with itching and rash". The action taken for dupilumab was unknown. Additional information: Initial information received on 29Jan2026 regarding an unsolicited valid non-serious case received from a patient. This case involves Elderly female patient who had blisters, issue With itching and rash while treated With Dupilumab [Dupixentl delivered Via Dupflumab singled ose premed pen and COVID-19 VACCINE. The patient's past medical history, rnedlcal treatment(s) , vaccination(s), concomitant disease, risk factors and family history were not provided. Concomitant medications included ACETYLSALICYLIC ACID (ASPIRIN 81). On an unknown date, the patient started taking Dupilumab solution for injection, strength 300mg/2mI at a dose of 300 mg every other week (QOW) subcutaneously for other atopiC dermatitis. On an unknown date, the patient received a dose of covid-19 vaccine at an unknown strength, dose, frequency, route for prophylactic vaccination. On an unknown date the patient developed a non-serious event blisters (blister) (unknown latency) following the first dose Intake (batch number: 5F772A and expiry date on 31Mar2028) of dupilumab and covtd-19 vaccine. On an unknown date the patient developed a non-serious event issue With Itching and rash (pruritus) (rash) (unknown latency) following the first dose intake (batch number: 5F772A and expiry date on 31Mar2028) of dupilumab and covid-19 vaccine. It was reported patient feels covtd vaccine caused her blisters, has issues With itching & rash. Action taken with DUPILUMAB (DUPIXENT) was unknown for all the events. Action taken with COVID-19 VACCINE (COVID-19 VACCINE) was not applicable for all the events. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
ASPIRIN 81; DUPIXENT