Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3043160 | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
Loss of hearing in one ear/deafness in one ear); Blurred vision; Extreme vertigo/vertigo so bad; Nausea/sickwith nausea/became very nauseated); Difficulty walking/could not walk across the room/Barely able to Walk; Balance issues/unbalanced; Initial information received on 10-Sep-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional). This case involves an unknown age and unknown gender patient who experienced loss of hearing in one ear/deafness in one ear), difficulty walking/could not walk across the room/barely able to walk, balance issues/unbalanced, blurred vision, extreme vertigo/vertigo so bad and nausea/sick with nausea/became very nauseated) after receiving Spikevax 2024-2025 Formula [COVID-19 vaccine MRNA OMICRON (JN.1) Moderna] and Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity, Sulphur and Penicillin. Concomitant medications included Metoprolol Tartrate for Product used for unknown indication; and Levothyroxine sodium (Synthroid) for Product used for unknown indication. On 20-Sep-2024, the patient received a dose of 0.5ml of suspect Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Jn.1) Moderna] not produced by Sanofi Pasteur (lot 3043160 and expiry date-06-Feb-2025) via intramuscular route in unknown administration site for COVID-19 prophylaxis. On 20-Sep-2024, the patient received a dose of 1 DF (dosage form) suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date in 2024 the patient developed balance issues/unbalanced (balance disorder) (unknown latency). On 21-SEP-2024 the patient developed difficulty walking/could not walk across the room/barely able to walk (gait disturbance) (latency-1 day). On 23-Sep-2024 the patient developed loss of hearing in one ear/deafness in one ear) (deafness unilateral), blurred vision (vision blurred), extreme vertigo/vertigo so bad (vertigo) and nausea/sick with nausea/became very nauseated) (nausea) (latency-3 days). Action taken was not applicable. An unknown corrective treatment was received for all the events. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria- The patient was hospitalized for all the events. The patient was discharged on 30-Sep-2024 (hospitalization for 7 days). The event of Deafness unilateral is considered as medically significant.; Sender's Comments: Sanofi Company Comment dated 19-Sep-2025: This case involves an unknown age and unknown gender patient who experienced loss of hearing in one ear/deafness in one ear), difficulty walking/could not walk across the room/barely able to walk, balance issues/unbalanced, blurred vision, extreme vertigo/vertigo so bad and nausea/sick with nausea/became very nauseated) after receiving Spikevax 2024-2025 Formula [COVID-19 vaccine MRNA OMICRON (JN.1) Moderna] and Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. Furthermore, patient information regarding medical history, clinical course excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Drug allergy
METOPROLOL TARTRATE; SYNTHROID