Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
once in a while the glass from the delivery has been shattered; This is a spontaneous report received from an Other HCP from product quality group. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal 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 "once in a while the glass from the delivery has been shattered". Causality for "once in a while the glass from the delivery has been shattered" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The nurse manager stated that they gave RSV to the pregnant women and the only issue they had is, once in a while the glass from the delivery has been shattered, but they have reached out for replacements, and they are okay now. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.