Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT |
(punctured) IPOL was administered post excursion, Max/low temperature reached: 9°C; Duration: 1 minute with no reported adverse event; Initial information received on 19-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old female patient who received (punctured) IPV (VERO) [IPOL] post excursion where max/low temperature reached: 9°c for the duration: 1 minute with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Nov-2025, the patient received 0.5 ml of IPV (VERO) Suspension for injection (strength- unknown, expiry date- 31-OCT-2026 and lot X1C891M) via intramuscular route in unknown administration site for Immunization post excursion where max/low temperature reached: 9°c for the duration: 1 minute with no reported adverse event (product storage error) (latency- same day). It was reported that, "nurse practitioner called to report an excursion that happened last April. Previous Excursion: None. Human error: Yes. 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.