Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1D141M | OT |
Ipol was administered post excursion with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA098047 This case involves a patient with unknown age and gender who was administered to IPV (Vero) [Ipol] (opened) post excursion 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 an unknown dose of suspect IPV (Vero), Suspension for injection (lot X1D141M, expiry date 31-Oct-2026; strength not reported) for Immunization and Ipol was administered post excursion with no reported adverse event (poor quality product administered) Reportedly, temperature excursion of negative disposition -max/lowtemperature reached: 24.2 ° F with duration of 12 hours. There was no previous excursion and no humar error involved. The product was administered after the excursion and extended stability data does not cover the excursion. 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.; Sender's Comments: US-SA-2025SA098047:General vaccine