Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | — | OT |
received a booster dose of YF-vax prior to the 10-year interval., with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown gender child patient who received a booster dose of Yellow Fever Vaccine - Us [Yf-Vax] prior to the 10-year interval, with no reported adverse event. This case was linked to US-SA-2025SA194574 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 - US, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site due to upcoming travel requirement (immunization) prior to the 10-year interval, with no reported adverse event (inappropriate schedule of product administration) (latency same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, a family of 5 came in to get YF-vax due to upcoming travel requirements; that the family told the Pharmacy that they had not gotten a YF-vax before; that it was not until after administration the pharmacy was alerted that 2-of the family members had had the vaccine 6-years prior. 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.; Sender's Comments: US-SA-2025SA194574: