Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
temperature excursion on punctured mdv of ipol temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with a vaccine that had temperature excursion on punctured MDV of IPV (VERO) [IPOL] temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event. On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) was exposed to temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event (product storage error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Human error was involved (refrigerator being unplugged by mistake). Previous excursion on 24-apr-2025 max of 8.44 degrees Celsius for 13 minutes, due to the refrigerator door being left open. 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. Additional information was received on 13-Jun-2025 from other healthcare professional: case was updated to valid from non-valid; text amended accordingly.