Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3043160 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
loss of hearing in one ear/deafness in one ear; blurred vision; extreme vertigo/vertigo so bad; nausea/sick with nausea/became very nauseated; difficulty walking/could not walk across the room/barely able to walk; balance issues/unbalanced; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear), GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk), BALANCE DISORDER (balance issues/unbalanced), VISION BLURRED (blurred vision), VERTIGO (extreme vertigo/vertigo so bad) and NAUSEA (nausea/sick with nausea/became very nauseated) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for Prophylactic vaccination. Previously administered products included for Drug use for unknown indication: Penicillin and Sulphur. Past adverse reactions to the above products included Drug allergy with Sulphur; and Penicillin allergy with Penicillin. Concurrent medical conditions included Drug hypersensitivity, Drug allergy (Sulphur) and Penicillin allergy. Concomitant products included Metoprolol tartrate and Levothyroxine sodium (Synthroid) for an unknown indication. On 20-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In 2024, the patient experienced BALANCE DISORDER (balance issues/unbalanced) (seriousness criterion hospitalization). On 21-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk) (seriousness criterion hospitalization). On 23-Sep-2024, the patient experienced DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear) (seriousness criteria hospitalization and medically significant), VISION BLURRED (blurred vision) (seriousness criterion hospitalization), VERTIGO (extreme vertigo/vertigo so bad) (seriousness criterion hospitalization) and NAUSEA (nausea/sick with nausea/became very nauseated) (seriousness criterion hospitalization). The patient was hospitalized from 24-Sep-2024 to 30-Sep-2024 due to BALANCE DISORDER, DEAFNESS UNILATERAL, GAIT DISTURBANCE, NAUSEA, VERTIGO and VISION BLURRED. At the time of the report, DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear), GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk), BALANCE DISORDER (balance issues/unbalanced), VISION BLURRED (blurred vision), VERTIGO (extreme vertigo/vertigo so bad) and NAUSEA (nausea/sick with nausea/became very nauseated) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. The patient's past medical history, medical treatment (s), vaccination (s) and family history were not provided. Action taken with Fluzone high dose was reported as not applicable. An unknown corrective treatment was received for all the events. It was not reported if the patient received corrective treatment for all the events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Drug allergy (Sulphur); Drug hypersensitivity; Penicillin allergy
Metoprolol tartrate; Synthroid