Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK125AA | OT / LA |
instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 25 years old female patient to whom had administered Yellow Fever Vaccine - [YF-VAX] was mixed with sterile water instead of the provided diluent (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2025, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine - Solution for injection (strength: standard, frequency: once, expiry date: 31-Oct-2025 and lot UK125AA) a via subcutaneous route in the left arm as immunization and instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event) (product preparation error) (poor quality product administered) (latency: same day). Action taken: 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.