Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK134AA | OT / LA |
the vaccine was mixed with the incorrect diluent of sterile water with no reported AE; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old female patient who was administered yellowfever vaccine- [YF-VAX] that was mixed with the incorrect diluent of sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received a dose of 0.5 ml of suspect yellowfever vaccine- solution for injection (lot UK134AA, strength: standard and frequency: once) (expiry date not reported) via unknown route in the left arm for immunization and was mixed with the incorrect diluent of sterile water with no reported adverse event (product preparation error) (Latency: same day). Reportedly, The pharmacist reported that 2 consumers received a medication error with the YF vaccine, that the consumers are family members. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA166823:consumer 2