Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
I wound up getting tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I wound up getting tinnitus) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (had received "6 or 7" doses of Spikevax already). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (I wound up getting tinnitus). At the time of the report, TINNITUS (I wound up getting tinnitus) outcome was unknown. No concomitant medications were reported. It was reported that the patient received 6 or 7 doses of Spikevax throughout her life, with the most recent Spikevax 24-25 administered in Sep-2024. The patient received high-dose flu vaccine, whose manufacturer and date were not reported. The patient developed tinnitus following flu shot. The patient emphasized that the event was related to the flu shot and not the COVID vaccine, which she had received multiple times. She also reported the event tinnitus to the company responsible for administering the flu shot, clarifying that it was not related to Spikevax. No treatment medications were reported.