Received Apr 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | — |
she was opening and closing the fridge door to conduct inventory temperature reached: 1.3 C for 27 minutes with no AE; Initial information received on 06-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an unknown age and gender patient and product storage error after the IPOL (IPV (Vero)) vaccine was stored in a refrigerator. On 02-Mar-2026, the healthcare professional was opening and closing the fridge door to conduct inventory when the temperature reached 1.3°C for 27 minutes with no adverse event (Product storage error, Onset: 02-Mar-2026, Latency: unknown). Action taken: Not applicable. Reportedly, the healthcare professional was unsure if the IPOL vaccine had been administered post-excursion. Extended stability data did not cover the excursion for the punctured IPOL product. 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.
Comments: NONE