Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
not feeling well; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA343018 (Sanofi), AE-021913 (BioNTech SE). An 80-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Nov2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Nov2025 as 300 mg, weekly (Lot number: FW1083, Expiration Date: 31Aug2027) subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well". The action taken for dupilumab was unknown. Batch/lot number is not provided, and it cannot be obtained.
DUPILUMAB