Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | WIC831M | OT |
temperature excursion reached 5 hours and 38 minutes at 33.6F + 48 minutes at 46.8F, they had administered an opened IPOL to 2 patients with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old male patient who was administered with IPV (VERO) [IPOL] that had a temperature excursion at 33.6f for 5 hours and 38 minutes + at 46.8f for 48 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-May-2025, the patient received a dose of 0.5ml of suspect IPV (VERO) Suspension for injection (lot WIC831M, standard strength, frequency once and expiry date-30-Nov-2025) via intramuscular route in unknown administration site for Immunization that had a temperature excursion at 33.6f for 5 hours and 38 minutes + at 46.8f for 48 minutes with no reported adverse event (poor quality product administered) (latency-same day). Reportedly-The product was administered to two patients; They were not aware there was excursion prior administration; The door of refrigerator that may have been left open. 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.