Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | LL8396 | — |
needle disengaged from the syringe when they it back and stayed on the patients arm; needle disengaged from the syringe when they it back and stayed on the patients arm; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Aug2025 as dose 1, single (Lot number: LL8396, Expiration Date: Apr2026), in arm for immunisation, Device Lot Number: HN8587, Device Expiration Date: Sep2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (medically significant), INJURY ASSOCIATED WITH DEVICE (medically significant) all with onset 25Aug2025, outcome "unknown" and all described as "needle disengaged from the syringe when they it back and stayed on the patients arm". Clinical course: reporter explained that they had two Abrysvo vaccines that, when giving the injection, the needle disengaged from the syringe when they pulled it back and stayed on the patients' arm. Pharmacy had been giving the injections for a long time, switched from Arexvy to Abrysvo for RSV because could do pregnant patients and regular patients, so had been using Abrysvo for quite some time, and after numerous vaccinations this issue never happened until now. The issue happened for the first time two weeks before 26Aug2025, last Monday or Tuesday (in Aug2025) and then yesterday (on 25Aug2025). Yesterday a seasoned tech who gave injections had two incidents when giving Abrysvo vaccine where the needle disengaged from syringe when pulled back. The needle did stick and stayed in the arm of the two patients involved. When withdrew, needle remained in the two patient's arms. They reconstituted the vaccine according to the instructions as usual but they didn't work well. They had a box of five vaccines. So far they used three and two out of them were faulty. There were 2 other vial adapters left in box and the other one was fine. She wanted to know why this issue might have happened. For 1st Abrysvo: just had vial adapter, packaging discarded. Abrysvo diluent syringe: Lot: HN8587, Expiry: Sep2026. Syringe used was not in packet of Abrysvo. Syringe that had to attach to inject medication was the BD precision glide needle 25g, 1 inch (Lot: 4178824, Expiry: 30Sep2029). One vial was available to be returned, some components were discarded, syringes were discarded. The reporter assessed event "When withdrew, needle remained in arm" as serious due to medically significant for going forward. Thought the patients were able to receive the vaccine, no ill affects, didn't want to have happen again. Re-went over everything as far as reconstitution and vaccine and everything that occurred was exactly as outlined as in package insert information, very weird. Causality for "needle disengaged from the syringe when they it back and stayed on the patients arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Based on the information given, the Company confirms that the event injury associated with device is unrelated to the suspected drug RSV VACCINE PROT.SUBUNIT PREF 2V and most likely to the device constituent of RSV VACCINE PROT.SUBUNIT PREF 2V (malfunction) wherein the needle disengaged from the syringe when they pulled it back it stayed on the arms of the patient.,Linked Report(s) : US-PFIZER INC-202500170519 Same reporter/drug/event for different patients;