Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | — | — |
Nurse may have reconstituted vaccine with sterile water instead of Normal saline with no reported adverse event; Initial information received on 04-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient and nurse, believed she may have reconstituted yellow fever vaccine (YF-VAX) with sterile water instead of normal saline with no reported adverse event. The patient's past medical history, medical treatment(s), past drugs, vaccination(s), family history were not provided. The patient received yellow fever vaccine [YF-VAX] solution for injection (batch/lot number and expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for prophylactic vaccination (Immunisation). As a nurse, the patient believed she may have reconstituted vaccine with sterile water instead of normal saline with no reported adverse event (Product preparation error, onset: unknown, latency: same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported in follow-up that, "There was no adverse event. The patient is fine. Sterile water was used to dilute med instead of normal saline". 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. Additional information received on 23-MAR-2026 from a nurse: Case was upgraded to valid case from non-valid case. Clinical course updated.
Comments: NONE