Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H2522 | — |
Got dizzy; This non-serious case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number H2522, expiry date APR-2025) for prophylaxis. Concurrent medical conditions included hypertension. Concomitant products included lisinopril dihydrate (Lisinopril). On 06-SEP-2023, the patient received Arexvy. On 06-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Got dizzy). The outcome of the dizziness was not resolved. It was unknown if the reporter considered the dizziness to be related to Arexvy. It was unknown if the company considered the dizziness to be related to Arexvy. Additional Information: GSK receipt date: 22-APR-2025 The patient got dizzy one hour after Arexvy shot and had continued dizziness even till the time of reporting. She had seen a neurologist for Computerized Tomogram scan and Magnetic resonance imaging which were negative and an inner ear specialist with vestibular testing etc, all were negative. The reporter asked about how many reported cases had continued dizziness and when do the reproter expect this to subside. The symptom was not treated.
Hypertension
Lisinopril
Test Name: CT scan; Test Result: Negative ; Test Name: laboratory test; Test Result: Negative ; Test Name: MRI; Test Result: Negative ; Test Name: vestibular test; Test Result: Negative