Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT |
patient received ipol that exposed to Max/low temperature reached: 9.5 degrees C for 36 minutes no reported adverse event; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that was exposed to max/low temperature reached: 9.5 degrees c for 36 minutes 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 unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength) with lot X1C891M and expiry date 31-OCT-2026 via unknown route in unknown administration site for Immunization that was exposed to max/low temperature reached: 9.5 degrees c for 36 minutes no reported adverse event (poor quality product administered) (latency same day). It was reported, "fridge was cycling weird. There was no previous excursion. Human error not involved. extended stability data did not cover the excursion. Product was administered." 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.