Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | WIC831M | OT |
temperature excursion reached 5 hours and 38 minutes at 33.6f + 48 minutes at 46.8fproduct/s: opened ipol with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered to temperature excursed opened -IPV (Vero) [IPOL] which reached 5 hours and 38 minutes at 33.6F+ 48 minutes at 46.8F, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Apr-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot WIC831M, expiry date 30-NOV-2025, strength standard and frequency once) via intramuscular route in unknown administration site for Immunization and temperature excursion reached 5 hours and 38 minutes at 33.6f + 48 minutes at 46.8fproduct/s: opened ipol with no reported adverse event (product storage error). Reportedly, they had an opened an IPOL and since it was a multidose vial, they were not aware that there has been an excursion prior to it being administered. She wanted to know what the consequences would be and what should be done.Physician said they were not aware what the exact reason for the excursion is, stating the door may have been left opened. 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.