Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | — | OT |
sterile water was used as a diluent, confirmed that the incorrectly reconstituted YF VAX was administered with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received Yellow Fever Vaccine - [YF-Vax] which was reconstituted with 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 an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization which was reconstituted with sterile water with no reported adverse event (product preparation error) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, Sterile water was used as diluent in reconstitution of vaccine. 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. No routine follow up possible as reporter did not consent to be contacted.