Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1E141M | OT / LA |
patient received the ipol twice with no reported adverse event; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5-year-old male patient who received the IPV (VERO) [IPOL] twice with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Aug-2025, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection strength: standard frequency: once of lot X1E141M and expiry date: 31-Oct-2026 via subcutaneous route in the left deltoid for Immunization and patient received the ipol twice with no reported adverse event (extra dose administered) (latency: on same day). Reportedly,Caller stated that 3 doses of PENTACEL and 2 doses of IPOL were administered to a patient. Second dose of IPOL was administered on 05-AUG-2025. Caller reports that a patient received an additional IPOL vaccine and requests information regarding potential AE (adverse event) or recommendations on how to proceed. Caller adds that the patient received 3 doses of PENTACEL and the IPOL twice. 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.