Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (POLIOVAX) | SANOFI PASTEUR | UNK | W1C751M | OT |
Open ipol was administered post excursion with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who had open IPV (VERO) [IMOVAX POLIO] was administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,Concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot W1C751M, Expiry date: 18-Nov-2025, strength was unknown via unknown route in unknown administration site for Immunization of open ipol was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). Reportedly "Reason: power outage Max/low temperature reached: max temp of 63.3°F (17.39°C)Duration: 12 hours and 25 mins. Previous Excursion? NONE. Human error? NO.Does extended stability data cover the excursion? The UNOPEN products are supported by the extended stability information post excursion but the punctured IPOL is not. " 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.