Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407245 | — |
Light headed; Nausea; Muscle spasms; Headache; Bone pain; Vaccine was administered to 55 year old patient; This spontaneous case, initially received on 06-Nov-2025, was reported by a health professional and concerns n adult male patient. Concomitant Medications: Unknown Medical History: Unknown Administration of company suspect drug: On 04-Nov-2025, the patient received Fluad (TIV) for Indication not reported, Dose regimen: 0.5 ml, route of administration: not reported, anatomical location: not reported, Lot number: 407245. No additional suspect drugs. Adverse reactions/events and outcomes: On 04-Nov-2025, the patient experienced Vaccine was administered to 55 year old patient (outcome: Unknown). On an unknown date, the patient experienced Light headed (outcome: Unknown), Nausea (outcome: Unknown), Muscle spasms (outcome: Unknown), Headache (outcome: Unknown), Bone pain (outcome: Unknown). Nurse called and informed that Fluad vaccine for 65 and older was administered to a patient aged adult patient. The nurse described that the patient had some adverse events: light-headedness, nausea, muscle spasms, headache, and bone pain. The nurse informed that the doctor was in contact with the patient and suggested that the patient take plenty of water, and the symptoms were expected to improve with time. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment of the events.; Reporter's Comments: Due to the spontaneous nature of the case, the all events are considered related for reporting purposes except Vaccine was administered to 55 year old patient is not related due to nature of event (special situation).
Comments: None