Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 5 | W1C751M | OT / RA |
inappropriate use due to administration of extra dose of IPOL with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old male patient who was inappropriately administered an extra dose of IPV (Vero) [IPOL] 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Influenza vaccine (Flu) for Immunisation. On 23-Sep-2025, the patient received an extra dose of 0.5mL (dose 5) of suspect IPV (Vero), Suspension for injection (lot W1C751M, expiry date 18-Nov-2025, strength standard and frequency once) via intramuscular route in the right deltoid for Immunization, with no reported adverse event (extra dose administered) (latency same day). 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.
Dtap; Flu