Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LL8391 | — |
the liquid/diluent spilled on her; the liquid/diluent spilled on her; the luer lock broke off; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 15Sep2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) and all described as "the liquid/diluent spilled on her"; DEVICE BREAKAGE (non-serious), described as "the luer lock broke off". Additional information: The reporter was contacted for clarification on how the product broke. She stated that, when she connected the syringe and turned the Luer Lok, it broke off and the liquid/diluent spilled onto her. Causality for "the liquid/diluent spilled on her" and "the luer lock broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).