Received Jun 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
First excursion was at 9.8C for 25 minutes while the second excursion was at 8.7C for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event; Initial information received on 23-Jun-2025 (with live follow-up information received on 23-Jun-2025)regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with IPV (VERO) [IPOL] vaccine that had first excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization that had a temperature excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event (product storage error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- extended stability data does not cover the excursion, human error was involved, The product was administered 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.