Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | — |
Vaccine was administered post excursion with no adverse event; Initial information received on 02-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient who received 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 Y1D03P1 and 31-AUG-2027) (dose, strength, route: unknown) post excursion with no adverse event (poor quality product administered) (latency 1 day) in unknown administration site for Prophylactic vaccination (vaccination). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported that:-Reason: The sensor was brushing against vaccines.lowest temperature reached: 1.44CDuration: 49 minutes Previous Excursion:- NO Human error:- NO Administered post-excursion: YES Does extended stability data cover the excursion: unknown. The nurse reported that at this time they are not sure if the IPOL was administered; that they see one dose was given, but deeper research is needed to see the exact date of 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.