Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 406984 | — |
Pain in arm; Gums start to swell; Gum start to hurt a lot; This spontaneous case, initially received on 30-Aug-2025, was reported by a non-health professional and concerns an adult male patient. Administration of company suspect drug: On 29-Aug-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: Not reported, Lot number: 406984. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Aug-2025, the patient experienced Gums start to swell (outcome: Not Reported), Pain in arm (outcome: Not Reported), Gum start to hurt a lot (outcome: Not Reported). The consumer stated that there was pain in his arm for like an hour and then the next day his gums started to swell and hurt a lot. In the previous night of this report started to hurt a lot. He had been taking Advil and got stiff. He planned to see his dentist. Flucelvax (TIV) action taken: Not Applicable Flucelvax (TIV) dechallenge: Not applicable Treatment medication: Advil Reporter's assessment: The reporter (patient) did not provide a seriousness or causality assessment for events reported.; Reporter's Comments: Due to spontaneous nature of case events were assessed as related for reporting purpose
Comments: None