Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49P1 | — |
Temperature excursion for IPOL maximum/lowest temperature reached: 1.8C Less than 30 mins/reason: Cool packs from coolers placed in the refrigerator was administered post excursion with no reported adverse event; Initial information received on 03-Apr-2026 regarding an unsolicited valid non-serious case received from unknown healthcare professional (HCP). This case involves a 14 year old male patient who received an unknown dose of suspect IPV (VERO) [IPOL] post excursion with maximum/lowest temperature reached: 1.8C less than 30 mins/reason: cool packs from coolers placed in the refrigerator was administered post excursion with no reported adverse event. No patient(s) involved. On unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (strength and frequency unknown) batch:Y1D49P1, expiry: 30-Sep-2027 via unknown route: unknown for prophylactic vaccination(immunisation) post excursion with maximum/lowest temperature reached: 1.8C less than 30 mins/reason: cool packs from coolers placed in the refrigerator was administered post excursion with no reported adverse event (Product storage error). It was reported "human error was involved and product was administered. The extended stability data did not cover the excursion". 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.
Comments: NONE