Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
Temperature excursion: Max/low temperature reached: 72°F Duration: 9 days, with no adverse event; Initial information received on 14-Nov-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 went under temperature excursion: negative disposition- max/low temperature reached: 72°F duration: 9 days, with no 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 number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and went under temperature excursion: max/low temperature reached: 72°f duration: 9 days, with no adverse event (poor quality product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence It was reported 'vaccine coordinator said that they had a smart fridge where they used to store their vaccines. She continued to say that the screen blacked out due to a system error and no data was logged for several days. She reiterated that the fridge was turned on the whole time the screen was blacked out. No, previous excursion and human error occurred. The product was administered post-excursion. The extended stability data did not cover the excursion.' 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.