Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT |
Ipol was given post excursion to one patient with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient to whom received IPV (Vero) [Ipol] was given post excursion to one patient 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, in Apr-2025 ,the patient received a unknown dose of suspect IPV (Vero) Suspension for injection (strength: unknown, expiry date: 31-Oct-2026 and lot X1C891M) via unknown route in unknown administration site as prophylactic vaccination (immunization) and was given post excursion to one patient with no reported adverse event (poor quality product administered) (same day latency). Reportedly: Max/low temperature reached: 10 MINS 8.8C Reason: Unknown, Human error: No, the extended stability data cover the excursion all except for the open IPOL. The caller reported that the excursion took place on 04Apr2025; that they were made are of the incident after the vaccine was administered; that there is no more information available for this report due to the caller's computer was down at the time of the call. Action taken: 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.