Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK137AA | OT |
inadvertently giving an extra dose of YF-VAX to a patient with no reported adverse event; YF-VAX given as IM to a patient with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 10 years old female patient who inadvertently administered an extra dose yellow fever vaccine - [YF-VAX] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications Included Typhoid Vaccine Polysacch VI (TYPHIM VI) for Immunisation. On 31-May-2025, the patient inadvertently received 2 doses of (0.5 ml dose) of suspect yellow fever vaccine, lot UK137AA, via subcutaneous route,UK137AA via intramuscular route both with (formulation :Solution for injection, expiry date:31-Jan-2026,strength :standard, frequency: once) in unknown administration site for Immunization with no reported adverse event (extra dose administered) (incorrect route of product administration) (latency: same day). Reportedly, She said that she had multiple patients that were going to another country; they needed a vaccination of YF-VAX and TYPHIM VI. 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.
TYPHIM VI