Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Experienced some very mild soreness in the arm; This spontaneous case, initially received on 09-Oct-2025, was reported by a health professional and concerns an adult male patient. Relevant medical history and concomitant medication was unknown. Administration of company suspect drug: On 08-Oct-2025, the patient received Flucelvax (TIV) for Indication: Unknown, Dose regimen: not reported, Route of administration: not reported; Anatomical Location: Arm, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Oct-2025, the patient Experienced some very mild soreness in the arm (outcome: Unknown). On 08-Oct-2025, the patient received his annual immunization of the 25-26 Flucelvax vaccine via Health Services. The patient had experienced some very mild soreness in the arm in which the vaccine was administered. There were no other issues or symptoms to report at the time of reporting. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter reported event seriousness as unknown and causality assessment was not reported.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes
Comments: None