Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
the tip injector of Abrysvo broke when they were mixing it; This is a spontaneous report received from a Pharmacist from product quality group. It was not reported if a patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "the tip injector of Abrysvo broke when they were mixing it". Additional information: The reporter requested for a replacement because the tip injector of Abrysvo broke when they were mixing it. Causality for "the tip injector of abrysvo broke when they were mixing it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.