Received Apr 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49P1 | IM |
Temperature excursion: negative disposition and product used, Refrigerator door was left opened too long while staff was grabbing vaccines with no reported adverse event; Initial information received on 08-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 4 years female patient who received suspect IPV (VERO) [IPOL] post excursion with maximum/lowest temperature reached: 8.2 degree Celsius duration out of labelled range: 5 minutes with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, concomitant medications were not provided. On 02-Apr-2026, the patient received (dose 4 ) 0.5 ml dose of suspect IPV (VERO) [IPOL] , Suspension for injection, frequency: once, strength :standard (batch number: Y1D49P1, expiry: 30-Sep-2027) via intramuscular route in unknown administration site for immunization, post excursion with Max/Low Temperature reached: 8.2 degree celsius Duration out of labelled range: 5 minutes with no reported adverse event (Product storage error). It was reported "human error was involved IPOL Cause: Refrigerator door was left opened too long while staff was grabbing vaccines on 30-Mar-2026 , Previous excursion: None and MA (Medical assistant) initially gave PV information for a total of 9 patients that were administered with the punctured IPOL after 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