Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
Exploded, it just broke and everything went everywhere; The initial case was missing the following minimum criteria: not reportable adverse event. Upon receipt of follow-up information on 17Oct2025 this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Exploded, it just broke and everything went everywhere". Additional information: "the patient has been using Abrysvo (Act-O-Vial) for quite a while. The one you put together and when I went to do it this morning, just a little while ago the thing that just exploded it just broke and everything went everywhere. I have never had that happened." NDC Number: 0069-0344-01. UPC Number: 300690344010. Causality for "exploded, it just broke and everything went everywhere" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).