Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
temperature excursion of open ipol; temperature of 9.6 degrees C for 11 minutes with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves temperature excursion of open IPV (VERO) [IPOL]; temperature of 9.6 degrees C for 11 minutes with no reported adverse event. No patient's involved. On an unknown date, the caller reported that an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) had temperature excursion with temperature of 9.6 degrees C for 11minutes with no reported adverse event (product storage error). Reportedly- extended stability data covers the excursion, There was no previous 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.