Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
Opened ipol exposed to 8.07 °C to 9.76 °C upto 14 minutes also it has been exposed to several temperature excursions. After excursions this was administered to three patients 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 3 patient and is reported opened IPV (VERO) [IPOL] exposed to 8.07 °c to 9.76 °c upto 14 minutes also it has been exposed to several temperature excursions after excursions this was administered to three patients 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, IPOL exposed to 8.07 °c to 9.76 °c upto 14 minutes also it has been exposed to several temperature excursions, after excursions this was administered to three patients Suspension for injection of lot W1C831M and expiry date: 21-Nov-2025 (strength and dose: not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (latency: on same day). Reportedly, Previous Excursion Dec-2024 - 3.2 C to 8.67 C for 15 minutes, with IPOL (opened) Aug-2024 - 4.97 C to 8.27 C for 15 minutes, with IPOL (opened) May-2024 - 4.97 C to 8.27 C for 15 minutes, without IPOL (opened) Jan-2024 - 4.16 C to 9.02 C for 15 minutes, without IPOL (opened)Human error: No. 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.