Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C751M | OT |
ipol was administered after temperature excursion with maximum/lowest temperature reached: 28.6 fahrenheit duration 1 hour and 13 minutes with no reported adverse event; Initial information received on 06-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] after temperature excursion with maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 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), Suspension for injection, lot W1C751M, expiry date:18-nov-2025,strength not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization) post excursion where maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 minutes with no reported adverse event (poor quality product administered) (unknown latency). Reportedly, human error was not involved; Reason: Unknown. The extended stability data doesn't cover the excursion and product has been administered post excursion. 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.