Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
encephalitis; This serious case was reported by a other health professional and described the occurrence of encephalitis in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 04-OCT-2024, the patient received Arexvy. On 27-NOV-2024, 54 days after receiving Arexvy, the patient experienced encephalitis (Verbatim: encephalitis) (serious criteria hospitalization and GSK medically significant). On 10-JAN-2025, the outcome of the encephalitis was resolved (duration 1 month 14 days). It was unknown if the reporter considered the encephalitis to be related to Arexvy. The company considered the encephalitis to be unrelated to Arexvy. Additional Information: GSK receipt date: 22-APR-2025 The reporter reported that the extensive work up in hospital and after the hospital. On high-dose steroids for about 8 weeks. On the day of reporting in the office patient was fully recovered. The reporter reported that the patient complete work up without another diagnosis. The patient was in hospital for encephalitis unspecified to unspecified. The expiry date of Arexy was unknown.; Sender's Comments: Encephalitis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.