Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 27NG7 | — |
one was sent to the hospital because she's really bad/patient was hospitalized; This serious case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 27NG7, expiry date 31-OCT-2025) for prophylaxis. On 20-NOV-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: one was sent to the hospital because she's really bad/patient was hospitalized) (serious criteria hospitalization). The outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Arexvy. The company considered the hospitalization to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 14-MAR-2025 The two patients that received Arexvy one was in the hospital, and one was in the nursing home. Both patients stay in the nursing home, one was sent to the hospital because she's really bad. They did not provide details as to what really bad. The sales representative did not know which patient was hospitalized or what occurred with the other patient. She stated that information was not relayed to her and what was provided was all the information she had. She also stated that the organization wanted to remain anonymous but that she would call back if they had any additional information to provide. The reporter did not consent to follow-up. This case was linked with case US2025031537 reported by the same reporter, for different patient.; Sender's Comments: Hospitalization is an unlisted event which is considered unrelated to GSK vaccine Arexvy.