Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
luer lock failed, the syringe was no longer attached to the needle; needle still hanging from patient's arm; luer lock failed, liquid leaked down arm; when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm; when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm; This is a spontaneous report received from a Pharmacist. A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Oct2025 as dose number unknown, single (Lot number: LL8391, Expiration Date: May2026) at the age of 65 years for immunisation, Device Lot Number: HT4720, Device Expiration Date: Dec2026 (Diluent Syringe); Device Lot Number: J591,Device Expiration Date: 29Nov2028 (Vial Adapter). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious) with onset 23Oct2025, outcome "unknown", described as "luer lock failed, liquid leaked down arm"; DEVICE CONNECTION ISSUE (non-serious) with onset 23Oct2025, outcome "unknown", described as "luer lock failed, the syringe was no longer attached to the needle"; INJURY ASSOCIATED WITH DEVICE (non-serious) with onset 23Oct2025, outcome "unknown", described as "needle still hanging from patient's arm"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 23Oct2025, outcome "unknown", EXPOSURE VIA SKIN CONTACT (non-serious) with onset 23Oct2025, outcome "unknown" and all described as "when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm". Causality for "luer lock failed, the syringe was no longer attached to the needle", "needle still hanging from patient's arm", "luer lock failed, liquid leaked down arm" and "when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. Additional Context: Reporter regarding Abrysvo, had 2 shots malfunction today. The first one, literally, was injecting into patient's arm. The little plastic piece that locks onto luer lock, when she went to push it in, the luer lock part failed, with needle still hanging from patient's arm. The syringe was no longer attached to the needle, the liquid shot out the side. The first one, when the luer lock failed, the needle was still hanging from her arm. Clarified, was today, 23Oct2025, this occurred. Clarified specific presentation being referred to is, kit with separate antigen powder vial, diluent syringe and adapter piece. The adapter is what she was trying to describe before, the thing they try to poke the bottle with, the adapter, the piece that screws on to adapter, almost like a luer lock piece, the one that was lose. When she tried to do shot in patient's arm, it shot out the side of that. The luer lock was coming out the screw part. Clarified, when the medication leaked out, was running down patient's arm, the needle part came out, and liquid kind of went down her arm. Clarified, other than the liquid leaking down patient's arm, none of the leaking liquid had come into contact with anyone else. Reporter was wearing gloves.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500210836 same patient and different events;