Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK118AA | OT |
YF-VAX was given to a patient and the diluent used was sterile water with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 57 years old female patient to whom yellow fever vaccine -[YF-VAX] was given and the diluent used was 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 30-May-2025, the patient received a dose of 0.5 ml of suspect yellow fever vaccine, Solution for injection (lot UK118AA, expiry date 30-Sep-2025, strength: standard, frequency: once) via subcutaneous route in unknown administration site for immunisation and the diluent used was sterile water with no reported adverse event (product preparation error) (Latency: same day). Reportedly, an inappropriate use due to the use of an alternate diluent and not using the one supplied with the product. 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.