Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
something wrong with the syringe/ but it came out when he was doing the thing and then the liquid came out; Sharp edge/broken glass was found in attachment; something wrong with the syringe/ but it came out when he was doing the thing and then the liquid came out; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), SYRINGE ISSUE (non-serious), outcome "unknown" and all described as "something wrong with the syringe/ but it came out when he was doing the thing and then the liquid came out"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Sharp edge/broken glass was found in attachment". Causality for "something wrong with the syringe/ but it came out when he was doing the thing and then the liquid came out" and "sharp edge/broken glass was found in attachment" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.