Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | — |
Ipol was administered to patient post excursion, with no adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient who was administered to IPV (VERO) [IPOL] post excursion, with no 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 dose of suspect IPV (VERO), Suspension for injection (lot W1C831M and expiry 21-Nov-2025) (dose, strength, route and administration site: unknown) post excursion with no adverse events (poor quality product administered) (latency same day). Reportedly:-Max/low temperature reached and duration: The minimum temperature reached 34.2 F (1.22 C). The cumulative time below the recommended storage range was 888 hours. The maximum temperature reached 45.1 F (7.277 C),extended stability data cover the excursion: No 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.