Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
redness at the injection; pain at the injection site; Fever; Tiredness; feels shaky; cannot stand up; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 31-DEC-2025, the patient received Arexvy. On 05-JAN-2026, 5 days after receiving Arexvy, the patient experienced shaky feelings (Verbatim: feels shaky) and difficulty in standing (Verbatim: cannot stand up). In JAN-2026, the patient experienced dizziness (Verbatim: Dizziness). On an unknown date, the patient experienced injection site erythema (Verbatim: redness at the injection), injection site pain (Verbatim: pain at the injection site), fever (Verbatim: Fever) and tiredness (Verbatim: Tiredness). The outcome of the injection site erythema, injection site pain, fever, tiredness and dizziness were unknown and the outcome of the shaky feelings and difficulty in standing were not reported. It was unknown if the reporter considered the injection site erythema, injection site pain, fever, tiredness, dizziness, shaky feelings and difficulty in standing to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site pain, fever, tiredness, dizziness, shaky feelings and difficulty in standing to be related to Arexvy. Additional Information: GSK Receipt Date: 05-JAN-2026 The patient received a dose of an Arexvy vaccine. The first night of vaccination, she had a fever, pain at the injection site and redness at the injection sight. The second night of vaccination, she also had a fever and dizziness. At the time of reporting (today), she felt shaky and cannot stand up. The batch number was not provided upon follow up with the reporter.