Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Became ill; Felt sick; Real bad virus; Came hard to hearing within two weeks of the flu vaccine/Lost 65 percent of hearing in left ear; This spontaneous case, initially received on 21-Oct-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 09-Oct-2025, the patient received INN Flu Vaccine Seasonal for Active immunization for prevention of Influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: Adverse reactions/events and outcomes: On an unknown date of 2025, the patient Came hard to hearing within two weeks of the flu vaccine/Lost 65 percent of hearing in left ear (outcome: Not Reported). On an unknown date, the patient Became ill (outcome: Not Reported), Felt sick (outcome: Not Reported), Real bad virus (outcome: Not Reported). Non-health professional reported that 14 days later patient had tinnitus, and never ever had tinnitus and reporter said got to be kidding with patient she said no, for real. The nurse friend who was also nurse confirmed that he's hard of hearing and found vaccine he had she would tell but he also became hard to hearing within two weeks of the flu vaccine, did not know what happened and why this vaccine and its ingredients were somehow attacked the cochlear nerve in the ear and it could be bet any amount of money that many people in this country who received that vaccine had problems with their hearing. The patient confirmed that they had lost 65% of the hearing in their left ear and then became ill, feeling sick, as if they had a bad virus. They passed out on the kitchen floor and later explained what had happened. They had received a vaccine one week earlier and said that within that week, they lost their hearing. After visiting an audiologist and then an ENT specialist for multiple tests, the providers had no idea what had caused it and referred the patient on, as they were uncertain about the reason. Something had happened to the cochlear nerve, but it was unknown what it was. The patient mentioned that they had received Flucelvax on 09-Oct-2025, and within seven days, they lost hearing in the left ear with an abrupt, acute onset. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter (non-health professional) did not provide causality assessment and seriousness reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, events considered related for reporting purposes