Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Pneumonia; Take Arevxy at 57 years; This serious case was reported by a nurse via call center representative and described the occurrence of pneumonia in a 57-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Take Arevxy at 57 years). On an unknown date, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the pneumonia to be related to Arexvy. The company considered the pneumonia to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 07-MAR-2025 A registered nurse reported a patient that probably received Arexvy on 30 November 2023, at 57 years which led to Inappropriate age at vaccine administration, but there was no certainty of it due to an incomplete paperwork fulfillment. Then, the patient came back to their facility with a previous case of pneumonia (already treated) and the registered nurse wondered if she could administer Arexvy to her. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine Arexvy.