Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
Temperature excursion: ipol- Duration: 1 Hour and 54 Minutes, Maximum/minimum temperaturereached: 53.6°F and administered after the excursion with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to IPV (Vero) [IPOL] which had temperature excursion- duration: 1 hour and 54 minutes, maximum/minimum temperature reached: 53.6°F 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 received an unknown dose of suspect IPV (Vero), Suspension for injectionl (lot number, expiry date and strength not reported) via unknown route in unknown administration site or Immunization and temperature excursion: duration: 1 hour and 54 minutes, maximum/minimum temperature reached: 53.6°F and administered after the excursion with no reported adverse event (poor quality product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, human error occurred as somebody left the door open. No other vaccines. 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.