Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4434A | — |
redness; Drug Exposure During Pregnancy; Drug Exposure During Pregnancy; This non-serious retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4434A, expiry date 12-DEC-2026) for prophylaxis. On 12-DEC-2025, the patient received Arexvy. The patient experienced injection site erythema (Verbatim: redness), vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and drug use in unapproved population (Verbatim: Drug Exposure During Pregnancy). The outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Arexvy. It was unknown if the company considered the injection site erythema to be related to Arexvy. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 15-DEC-2025 The patient had redness at the injection site.