Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C751M | OT |
New thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event; Initial information received on 03-Jul-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an unknown age female patient where reporter reported IPV (Vero) [IPOL] new thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event. Vaccine was not administered to patient(s). On 15-Jun-2025, dose of suspect IPV (VERO) Suspension for injection (batch number- W1C751M and expiry date- 18-NOV-2025) (dose, frequency, strength: not provided) for Immunization and new thermometers were being added to the refrigerator and it took a while for them to be adjusted properly with human error for 46 hours 36 minutes with no reported adverse event (product storage error). Reportedly, Low temperature reached: -15Jun2025: 1.0 degrees Celsius, 3 hours 24 minutes-16Jun2025: 1.1 degrees Celsius, 10 hours 50 minutes-17Jun2025: 1.3 degrees Celsius, 11 hours 7 minutes-19Jun2025: 1.1 degrees Celsius, 10 hours, 29 minutes-20Jun2025: 1.1 degrees Celsius, 10 hours 46 minutes, cumulative duration: 46 hours 36 minutes, Previous Excursion- No, Human error- Yes, Does extended stability data cover the excursion- No. 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.