Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Sore tongue - back right side; Sore injection site - right upper arm; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 09:30 as dose 1, single (right arm/shoulder) (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Allergy: latex" (unspecified if ongoing); "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: 01Sep2023; METOPROLOL TARTRATE, start date: 01Jun2022; PEPCID [FAMOTIDINE], start date: 01Jan2023. Past drug history included: Monostat, reaction(s): "Allergy: monostat". The following information was reported: INJECTION SITE PAIN (non-serious) with onset 01Oct2025, outcome "not recovered", described as "Sore injection site - right upper arm"; GLOSSODYNIA (non-serious) with onset 01Oct2025, outcome "not recovered", described as "Sore tongue - back right side". Therapeutic measures were not taken as a result of glossodynia, injection site pain. Additional information: Patient didn't received any other vaccines on the same date as the vaccination. Patient didn't received any other vaccines within 4 weeks prior to the vaccination. Patient took other medications within 2 weeks of the event started. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Arthritis; Hypercholesterolemia; Hypertension; Latex allergy; Penicillin allergy
PRAVASTATIN; METOPROLOL TARTRATE; PEPCID [FAMOTIDINE]