Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 5H777 | SYR / LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Pharmacist gave wrong vaccine; Arexvy in pregnancy; Arexvy in pregnancy; Arexvy at 35 years; anxiety; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of anxiety in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number withheld rx#, expiry date 25-OCT-2025) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Arexvy. On 07-AUG-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Pharmacist gave wrong vaccine), vaccine exposure during pregnancy (Verbatim: Arexvy in pregnancy), drug use in unapproved population (Verbatim: Arexvy in pregnancy) and inappropriate age at vaccine administration (Verbatim: Arexvy at 35 years). In AUG-2025, the patient experienced anxiety (Verbatim: anxiety). The outcome of the anxiety was not reported and the outcome of the wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration were not applicable. It was unknown if the reporter considered the anxiety to be related to Arexvy. It was unknown if the company considered the anxiety to be related to Arexvy. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Estimated Delivery/Due date: 24-SEP-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 10-AUG-2025 Vaccine not approved for Pregnant women. Pharmacist gave wrong vaccine and administered to 35 years pregnant patient which led to wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration. Concerns about premature delivery and concerns about protection for newborn, and her anxiety clear pharmacist error. Had 120-dollar co pay as well and newborn still may need Mab. Swelling concern for her unborn post care follow up.