Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | LG9827 | OT |
fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo; The initial case was missing the following minimum criteria: Reportable AE. Upon receipt of follow-up information on 21Aug2025, this case now contains all the 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 1, single (Lot number: LG9827, Expiration Date: 31Oct2025) intramuscular for immunisation, Device Lot Number: LG9827, Device Expiration Date: 31Oct2025. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo". Causality for "fell apart upon trying to reconstitute it/product off hit together like it came apart/product broken/returned photo was reviewed and the glass syringe was noticed to be cracked not broken for abrysvo" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The reporter said that they had an Abryso vaccine fell apart upon trying to reconstitute it, it fell apart upon trying to reconstitute it and the product off hit together like it came apart so, they could not continue to use. When probed for any side effects, the reporter stated that It was not given to the patient its just they couldn't physically use the product, they reported to request a replacement product when this happened. Reason of replacement, the reporter stated that because the product broken as they were trying to reconstitute it, they were unable to use the vaccine. The reporter confirmed that vaccine was not administered to any patient. Dose: 120microgram. The reporter stated that they still had the product and could return it. Received photo information included Vial lot: LG9827 (exp 2025/10); Diluent lot: HN8587 (exp 2026/09). Returned photo was reviewed and the glass syringe was noticed to be cracked not broken for Abrysvo.