Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
off label use for unapproved indication; This non-serious case was reported by a other health professional via call center representative and described the occurrence of off label use in unapproved age group in a 17-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included lung transplant, stem cell transplant, graft versus host disease in lung and lung disease obstructive (obstructive lung condition). Concurrent medical conditions included leukemia (stage 3) and bronchiolitis obliterans. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use in unapproved age group (Verbatim: off label use for unapproved indication). The outcome of the off label use in unapproved age group was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 A physician assistant reported that they had a 17 years old patient and unfortunately a lung transplant candidate, he had stage 3 leukemia and received a stem cell transplant as part of his curative therapy, and developed a very extensive chronic graft vs host disease, and with that something called Bronchiolitis obliterans which was a very developed obstructive lung condition, which unfortunately had not been controlled, and really had to received QA lung transplant, reporter question was if there was any way they could obtain RSV vaccine through your company. Reporter made it clear they were aware the age of the patient was not the indication for Arexvy, but that it was their intention to administer it to the patient as it could be lifesaving, which led to off label use for unapproved age group.
Bronchiolitis obliterans; Leukemia (stage 3)
Medical History/Concurrent Conditions: Graft versus host disease in lung; Lung disease obstructive (obstructive lung condition); Lung transplant; Stem cell transplant