Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | — | OT |
reconstituted product with a sterile diluent live virus instead of what comes with product with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case (live processed together on 05-Mar-2025) received from a Pharmacist. This case involves, the patient received the Yellow Fever Vaccine- [YF-VAX] as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Feb-2025, the patient received Yellow Fever Vaccine- Solution for injection (unknown strength, expiry date, batch number) for Immunization as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event (product preparation error) (latency-same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly, Temperature excursion: negative disposition, no human error and product not used. Caller previously reported that a dose of YF-VAX was administered to a patient after it had been reconstituted with an alternate diluent (not the intended YF-VAX diluent). The alternate diluent used for reconstitution was sterile diluent live virus vaccines. Caller noted that the invalid dose was administered on 28-Feb-2025. The patient is traveling on 15-Mar-2025. 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.