Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
Ipol was administered it to the patient, and they just forgot the vial back in the refrigerator/Confirmed the vial has not been used since the excursion with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who had administered with IPV (Vero) [IPOL] and they just forgot the vial back in the refrigerator/confirmed the vial has not been used since the excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (Vero) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) and they just forgot the vial back in the refrigerator/confirmed the vial has not been used since the excursion with no reported adverse event (product storage error) (same day latency). Reportedly, Negative Advice - Yes, Human Error - Yes. The caller reported a temperature excursion on a punctured MDV of IPOL and wanted to know if the product is still suitable for use. The caller reported that the products were exposed to a temperature of 74.2 degrees Fahrenheit and were out of range for a total of about 3 hours. Confirmed the vial has not been used since the excursion. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. Action taken: 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.