Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8454A | OT |
reported that a week and half after getting the fluzone hd hey began having musical ear syndrome; have developed a tremor in the voice box; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves an unknown age female patient who reported that a week and half after getting the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] began having musical ear syndrome and have developed a tremor in the voice box. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in January 2025, the patient received suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine dose 0.5 ml 1x(once) Suspension for injection in pre-filled syringe (strength unknown) lot UT8454A expiry date-30-Jun-2025 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date in 2025 the patient reported that a week and half after getting the fluzone hd began having musical ear syndrome (musical ear syndrome) and developed a tremor in the voice box (laryngeal tremor) (unknown latency). It was reported "that at first they could hear music in the ear 80 percent of the day; that now it is not as frequent and a lot less; that they can hear the music in the quiet and even if listening to a pod cast; that they are still having the issue; that with speaking with the their doctor and Ear Nose and throat specialist they never heard of this Musical Ear Syndrome; that at the neurologist the hearing was tested; that the consumer was not showing much of a hearing loss;" Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Not Recovered / Not Resolved for the event musical ear syndrome and was Unknown for the event laryngeal tremor