Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side; liquid from syringe leaked out/liquid from the syringe goes out the side; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 13Oct2025, 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), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation, Device Lot Number: J591, Device Expiration Date: 29Nov2028. The following information was reported: DEVICE DIFFICULT TO USE (non-serious), outcome "unknown", described as "attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "liquid from syringe leaked out/liquid from the syringe goes out the side". The reporter considered "attempted to administer two vaccines, the abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side" and "liquid from syringe leaked out/liquid from the syringe goes out the side" not related to rsv vaccine prot.subunit pref 2v. Causality for "attempted to administer two vaccines, the abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side" and "liquid from syringe leaked out/liquid from the syringe goes out the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The reporter has attempted to administer two vaccines, the Abrysvo twice and when they go attach the adapter and the syringe, it like does not, it popped off and then the liquid from the syringe goes out the side. When clarified error happened with two Abrysvo, reporter stated yes and they did one and then they try it again on another thinking it was just like a fluke or they put too much pressure, but then it happened again. There was no administration to any patient, and it was they could not get the liquid in there. Samples were available. These details are provided for the second kit: Abrysvo Carton: NDC: 00069034401, LOT: LL8391, EXP: May2026, Abrysvo Antigen Powder Vial: NDC: 00069020701, LOT: LL8391, EXP: May2026, Abrysvo Diluent Syringe: NDC: 00069025001, LOT: HT4720, EXP: Dec2026, Abrysvo Vial Adapter: NDC: Unknown, LOT: J591, EXP: 29Nov2028.