Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
temperature excursion for opened IPOL at 48 F for 10 minutes with no reported adverse event; Initial information received on 18-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age / gender patient who received (opened) IPV (VERO) [IPOL] exposed to temperature excursion at 48 f for 10 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 (opened) IPV (VERO) Suspension for injection (strength- unknown, expiry date- 21-NOV-2025 and lot W1C831M) via unknown route in unknown administration site for Immunization was exposed to temperature excursion for at 48 f for 10 minutes with no reported adverse event (poor quality product administered) (same day latency). Reportedly, human error was unknown. There was previous excursion. Reason for excursion was unknown, and the vaccine was administered. 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.