Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | HN8090 | — |
looked like they were leaking; The initial case was missing the following minimum criteria: Invalid due to other - info not qualifying for AE reporting - Product complaint. Upon receipt of follow-up information on 05Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Other HCPs from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HN8090, Expiration Date: 31May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "looked like they were leaking". Additional information: The Medical Assistant/office supervisor informed that they have two defective vials. The reporter clarified that there was no patient involvement with these defective vials. They were going to be given to patients, once they were defective, they were not able to be give to patients, looked like they were leaking. It seemed like 1 was fine, had 1 defective one, the other one seemed to have a little crack inside of case, could see the fluid. The reporter clarified, specific presentation of Abrysvo involved has, part supposed to be screwed on, with plastic adapter piece, with powder in vial and syringe with liquid. Only has 1 of the syringes, has both vials. The reporter clarified, second vial and all components for second vial, including, carton, diluent syringe and carton, all have same NDC, LOT, EXP, Manufacturer, as provided for first kit. Causality for "looked like they were leaking" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.