Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | HN8090 | — |
2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; 2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; This is a spontaneous report and received from Other HCPs 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: HN8090, Expiration Date: Aug2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid". Causality for "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).