Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Arm ache; Hot feeling all over her body, arms, legs, face; This spontaneous case, initially received on 15-Oct-2025, was reported by a non-health professional and concerns a female patient. The relevant medical history was reported as unknown. Administration of company suspect drug: On 08-Sep-2025, the patient received Fluad (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: No batch number available, would not be obtained due to no follow-up consent provided No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in 2025, the patient experienced Arm ache (outcome: Recovered / Resolved, stop date: 2025), Hot feeling all over her body, arms, legs, face (outcome: Not recovered / Not resolved). Patient got a flu shot on 08-Sep-2025, and she experienced arm ache for 5 to 6 days, but it was recovered and recently she started to experience, what she described, as a hot feeling all over her body, arms, legs, face. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter (non-health professional) considered the events as non-serious and causality assessment was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, the events were assessed as related for reporting puirpose