Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Low energy; Dizziness; low appetite; patient received a second dose of Arexvy; This non-serious case was reported by a other health professional via sales rep and described the occurrence of energy decreased in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (1st dose received in AUG-2024). Concurrent medical conditions included hypertension, osteoarthritis and allergic rhinitis. Concomitant products included lisinopril dihydrate (Lysinopril), celecoxib (Celebrex) and azelastine. On 10-SEP-2025, the patient received the 2nd dose of Arexvy. On 10-SEP-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received a second dose of Arexvy). On an unknown date, the patient experienced energy decreased (Verbatim: Low energy), dizziness (Verbatim: Dizziness) and decreased appetite (Verbatim: low appetite). The outcome of the energy decreased, dizziness and decreased appetite were not resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the energy decreased, dizziness and decreased appetite to be related to Arexvy. It was unknown if the company considered the energy decreased, dizziness and decreased appetite to be related to Arexvy. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient received a second dose of Arexvy. She was complaining of on-going symptoms since second dose. The low energy, low appetite, dizziness was reported as worsened were after the second dose. There was no additional information around the adverse event. The chronic kidney disease was actively being treated at the time of the Arexvy vaccination 2nd dose. Still being treated for chronic kidney disease after the Arexvy vaccine.
Allergic rhinitis; Hypertension; Osteoarthritis
Lysinopril; Celebrex; Azelastine