Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT |
couple of excursions for opened ipol: high temperature of 46.6F and was out of range for 45 minutes, the vaccine was also administered to the patient with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves elderly and unknown gender patient who was received IPV (VERO) [IPOL] that had couple of excursions were at high temperature of 46.6f and was out of range for 45 minutes, 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) lot (Y1A201M) Suspension for injection (lot number- Y1A201M and expiry date-31-Jan-2027) via unknown route in unknown administration site for Immunization that had couple of excursions were at high temperature of 46.6f and was out of range for 45 minutes, with no reported adverse event (poor quality product administered) (latency-1 day). Reportedly-The second excursion took place on June 2, 2025. The vaccine reached a high temperature of 47.5F and was out of range for 1 hour. 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.w