Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, 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 ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off". Causality for "the act-o-vial, they had a problem with it being really hard to push down; the needle also separate from that; needle breaking off" 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.