Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT |
possibly administered to a patient after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of an unknown age and gender who had been possibly administered IPV (VERO) [IPOL] after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit 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 the patient had been possibly administered IPV (VERO) (Suspension for injection) (lot number: Y1A201M; expiry date: 31-Jan-2027) (strength unknown) after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit with no reported adverse event for Immunization (poor quality product administered) (latency: same day). Reportedly, "Was it related to a human error? 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.