Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Arexvy received to pregnant 35 years old female; Nausea; Headache; Arexvy received to pregnant 35 years old female; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of nausea in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-MAY-2025, the patient received Arexvy. On 05-MAY-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Arexvy received to pregnant 35 years old female). On 06-MAY-2025, the patient experienced nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy received to pregnant 35 years old female). The outcome of the nausea and headache were resolving and the outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. It was unknown if the reporter considered the nausea and headache to be related to Arexvy. It was unknown if the company considered the nausea and headache to be related to Arexvy. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 07-MAY-2025 The pregnant patient received Arexvy vaccine with primary care provider clinic and reported concerns with having received the wrong vaccine to her prenatal care providers, including himself/herself, which led to vaccine exposure during pregnancy and product use for unapproved population. Patient was encouraged to report incident. The patient received nausea and headache.