Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | RA |
Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt; bump on my arm at the site of injection; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 10:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov2004; ROSUVASTATIN, start date: Feb2022; FLUARIX taken for immunisation, start date: 29Sep2025, stop date: 29Sep2025. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 08Oct2025, outcome "not recovered", described as "Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt"; VACCINATION SITE SWELLING (non-serious) with onset 08Oct2025, outcome "not recovered", described as "bump on my arm at the site of injection". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site swelling. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Additional information: Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt/bump on my arm at the site of injection.
Medical History/Concurrent Conditions: High cholesterol; Hypothyroidism
LEVOTHYROXINE; ROSUVASTATIN; FLUARIX