Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
his Tennitus has gotten worse; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus aggravated in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included arthritis (Arthritis), anxiety (Anxiety) and tinnitus (on his left ear). Concomitant products included omeprazole (Prilosec), gabapentin and mirtazapine (Remeron). On 19-MAR-2025, the patient received Arexvy. On 20-MAR-2025, 1 days after receiving Arexvy, the patient experienced tinnitus aggravated (Verbatim: his Tennitus has gotten worse). The outcome of the tinnitus aggravated was not resolved. It was unknown if the reporter considered the tinnitus aggravated to be related to Arexvy. It was unknown if the company considered the tinnitus aggravated to be related to Arexvy. Additional Information: GSK Receipt Date: 28-MAR-2025 The patient has a history of Tinnitus on his left ear. Patient reports that he received Arexvy on 3/19/2025. Since receiving the vaccine, his Tinnitus has gotten worse.
Medical History/Concurrent Conditions: Anxiety; Arthritis; Tinnitus (on his left ear)
PRILOSEC; GABAPENTIN; REMERON