Received Jun 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
administered vaccine that had temperature excursion Max/low temperature reached: Maximum 10 C, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 4 months old male patient who administered IPV (VERO) [IPOL] that had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jun-2025, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C831M, expiry date: 21-Nov-2025, strength: standard and frequency: once) via unknown route in unknown administration site for immunization and had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event (poor quality product administered) (Latency: same day). Reportedly, Human error was No. Reason: Fridge just gave out and they had to replace it. Product was administered post excursion. Extended stability data did not cover the 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.