Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
Upon attempting to puncture the jar it shattered in pharmacist hands; Upon attempting to puncture the jar it shattered in pharmacist hands; 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: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), PRODUCT CONTAINER ISSUE (non-serious) and all described as "Upon attempting to puncture the jar it shattered in pharmacist hands". Additional information: The pharmacist was reporting a defective Abrysvo vaccine. The product was completely lost and spilt everywhere. Causality for "upon attempting to puncture the jar it shattered in pharmacist hands" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).