Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT |
administered a dose of IPOL MDV which was involved in a temperature excursion with no reported adverse event; Initial information received on 21-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an infant and unknown gender patient who was administered with a dose of IPV (VERO) [IPOL] which was involved in a temperature excursion of low temperature which reached 48° fahrenheit with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Mar-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026; strength standard, frequency once) for Immunisation. On 15-Mar-2025, the patient was administered with a dose of Ipol MDV which was involved in a temperature excursion of low temperature which reached 48° fahrenheit with no reported adverse event (poor quality product administered) (product storage error) (latency same day). Reportedly, the vaccine Program Manager reporting that a clinic possibly administered a dose of Ipol MDV which was involved in a temperature excursion. There is no extended stability data cover for 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.