Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process; One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process; This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE MATERIAL ISSUE (non-serious), outcome "unknown" and all described as "One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process". Additional information: A pharmacist mentioned just in preparing that, for the Abrysvo vaccine that she has had like when she was preparing it, it was not administered to a patient but just when she was preparing it, and it's unknown that don't know how long ago this happened but she had to return two vaccines back to manufacturer because the, one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process. So, she had returned two doses of the Abrysvo vaccine because of malfunction when she was trying to prepare it for administration. The pharmacist said she went to the process correctly. She had given this vaccine many times before, it was just the individual 2 doses of the vaccine that there was a problem with it. The reporter considered "one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process" not related to rsv vaccine prot.subunit pref 2v. Causality for "one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process" 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.