Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 4 | Y1A212M | OT / RL |
inappropriate use due to dose administered too early with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old male patient who was inappropriately administered to IPV (Vero) [IPOL] dose too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Aug-2025, the patient received 0.5mL (dose 4) of suspect IPV (Vero), Suspension for injection (lot Y1A212M, expiry date 31-JAN-2027, strength not reported) via intramuscular route in the right thigh for Immunization and dose administered too early with no reported adverse event (inappropriate schedule of product administration) (latency same day). Reportedly, caller stated that the nurse checked with the physician if the dose for IPOL should be given and was told yes. Patient received the immunization at 12 months old, but they were indicated to receive it at 4 years old. No other Immunizations. 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.