Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Administration of a Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included common variable immunodeficiency (Patient had a condition called CVID which is an immunological disease which does not allow her body to produce full immunity when she receives vaccines). Previously administered products included Arexvy (first dose was received in 2023). The patient did not receive the 2nd dose of Arexvy. The patient experienced off label use (Verbatim: Administration of a Second dose). The outcome of the off label use was not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 The pharmacist reported that he had a patient who came in on the day of reporting for RSV vaccine (Arexvy). The reporter was wondering if still it was ok or the protocol was in regards of giving her a second RSV vaccine because per the centers for disease control and prevention, she did not need another additional one. It was recommended by the patient's immunologist. The patient was immunocompromised, and her immunologist recommended to have a second dose of RSV vaccine however, she had not received the dose. The batch number was not provided and a request for this information had been made.
Medical History/Concurrent Conditions: Common variable immunodeficiency (Patient had a condition called CVID which is an immunological disease which does not allow her body to produce full immunity when she receives vaccines)