Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Swelling, itching, pain at injection site lasting for 3 days; Swelling, itching, pain at injection site lasting for 3 days; Swelling, itching, pain at injection site lasting for 3 days; Nausea; Chills; This is a spontaneous report received from a Consumer or other non HCP. A 33-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Sep2025 at 19:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 05Sep2025, outcome "unknown"; NAUSEA (non-serious) with onset 05Sep2025, outcome "unknown"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Sep2025, outcome "recovered" (07Sep2025) and all described as "Swelling, itching, pain at injection site lasting for 3 days". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pruritus, vaccination site pain, nausea, chills. Additional information: patient received Advil for the events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.