Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Arm in the deltoid area has red area; Arm in the deltoid area has solid area; Deltoid got extremely soared; Warm to the touch; This spontaneous case, initially received on 31-Oct-2025, was reported by a non health professional and concerns an elderly female patient. At the time of the event the patient had Allergy to latex, Allergy to gluten, Allergy to corn, Allergy to soy. Concomitant medication was reported as unknown. Administration of company suspect drug: On 27-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5ml, Route of administration: Not reported, Anatomical location: Deltoid, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 27-Oct-2025, same day of vaccination, the patient experienced Deltoid got extremely soared (outcome: Not recovered / Not resolved), Warm to the touch (outcome: Not recovered / Not resolved). On 31-Oct-2025, 4 days after vaccination, the patient experienced Arm in the deltoid area has red area (outcome: Not recovered / Not resolved), Arm in the deltoid area has solid area (outcome: Not recovered / Not resolved). The patient was experiencing an adverse reaction to vaccine Fluad. On 27-Oct-2025, the patient received the vaccine in her deltoid and right after receiving it, it got extremely soared to the point she could not have anything touching it, she could not sleep on it. It was warm to the touch. The patient thought it would got away eventually, however, on the morning of this report (31-Oct-2025), 5 days (sic!) after receiving the vaccine, while she was getting dressed, she noticed that her arm in the deltoid area had solid red area about the size of a baseball ball (this was new, it had not been like this, not until this morning). Treatment measures associated with event: Nothing was done until now Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter assessed provides seriousness assessment as unknown for all events and did not provide causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for reporting purposes.
Allergy to grains; Gluten sensitivity; Latex allergy; Soy allergy