Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1D141M | OT |
maximum/minimum temperature reached: 48 °f for 30 minutes and Administered post-excursion with no adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited non-valid non-serious case received from other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that exposed to maximum/minimum temperature reached: 48 °f for 30 minutes with no adverse event On an unknown date, the patient received suspect IPV (VERO) Suspension for injection (Unknown strength) with lot X1D141M and expiry date 31-Oct-2026 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) that exposed to temperature excursion maximum/minimum temperature reached: 48 °f for 30 minutes with no reported adverse event (product storage error) (Unknown latency) Reportedly, Human error involved. There were no previous excursion. Extended stability data did not cover the excursion. Fridge door was left open for inventory. 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.