Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK211AA | — |
they did not realize that there was a normal diluent to dilute it, they reconstituted it with sterile water with no adverse event; Initial information received on 05-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child of unknown age and unknown gender patient and reporter reported that they did not realize that there was a normal diluent to dilute it, they reconstituted yellow fever vaccine (YF-VAX) with sterile water with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On an unknown date in Feb-2026, the patient received an unknown dose (frequency: once) of yellow fever vaccine solution for injection (batch number: UK211AA, expiry date: 31-Jul-2026) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation) which was reconstituted with sterile water and didn't realize that there was a normal diluent to dilute it with no reported adverse event (Product preparation error, latency: same day). A registered nurse (RN) called from a pediatric office and reported that they gave a child yellow fever vaccine, and they did not realize that there was a normal diluent to dilute it. They reconstituted it with sterile water, and they were wondering if it would be just as effective. The child had not complained or had any adverse reaction to it. 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. RN stated that it is not necessary to contact them again. Consent to be reached out again by the safety team for more information was declined. No additional information collected.
Comments: NONE