Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | OT |
Low Temperature reached at 13.4°C/3.9°C for 4 hours / 4.7°C for 3 hours and was administered,with no reported adverse event; Initial information received on 02-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to IPV (Vero) [IPOL] which had temperature excursion: negative disposition- low temperature reached at 13.4°c/3.9°c for 4 hours / 4.7°c for 3 hours,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 an unknown dose of suspect IPV (Vero), Suspension for injection (lot Y1D03P1, expiry date 31-Aug-2027 and strength not reported) via unknown route in unknown administration site for Immunization and low temperature reached at 13.4°c/3.9°c for 4 hours / 4.7°c for 3 hours and was administered, with no reported adverse event (poor quality product administered) (latency same day). It was reported the previous excursions still fall within the recommended storage conditions and were not considered as excursions. The cause was unknown; no one was in the office since it was during Saturdays, Max/Low Temperature reached: on 19Nov2025 at 13.4°C Duration out of labelled range: 30 minutes. Previous excursions: 1) 06Sep2025 at 3.9°C for 4 hours 2) 30Aug2025 at 4.7°C for 3 hours. The product was administered post-excursion and not suitable for use after the excursion. Human error was unknown. 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.