Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT / LA |
product administered post-excursion Duration and temperature excursion: at 9.38 °C for 25 minutes and at 1.69 °C for 6 hours and 6 minutes with no reported adverse event; Initial information received on 11-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7-year-old female patient whom product IPV (VERO) [IPOL] administered post-excursion duration and temperature excursion: at 9.38 °c for 25 minutes and at 1.69 °c for 6 hours and 6 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2025, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection strength: standard, frequency: once of lot Y1A201M and expiry date: 01-Jan-2027 via subcutaneous route in the left arm for Immunization post-excursion duration and temperature excursion: at 9.38 °c for 25 minutes and at 1.69 °c for 6 hours and 6 minutes with no reported adverse event (poor quality product administered) (latency: on same day). Previous Excursion: None, Does extended stability data cover the excursion: No, for opened IPOL. Was it related to a human error: No, Reason: Fridge malfunction/ problem ,Was product administered post-excursion: Yes 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.