Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LG9829 | — |
they had 2 abrysvo and it broke apart when they tried to enter the diluent into it; This is a spontaneous report received from a Pharmacist from product quality group, Program ID. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LG9829, Expiration Date: Oct2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it". Causality for "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The pharmacist on the line was calling about Abrysvo and reported that they had 2 abrysvo and it broke apart when they tried to enter the diluent into it. They are seeking replacement. One of the Abrysvo was just broke. The top of the diluent was broken. She just needs the diluent replaced. It broke apart before they even inserted it into the vial. She was not dealing with the second one and doesn't know how it broke, but the diluent broke on that one as well. The caller said that both of the Abrysvo were all from the same box. The caller confirmed no patient involvement.