Received Apr 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | IM |
Cold excursion, 1.5°- 1.8°C for 1 hour & 02 minutes/dose was given to a patient after the cold excursion with no AE; Initial information received on 12-Mar-2026 regarding an unsolicited valid non-serious case received from a practice registered nurse. This case involves 8 year old female patient who had administered dose of poliomyelitis vaccine (inactivated) (IPOL).after a cold excursion, 1.5°- 1.8°C for 1 hour & 02 minutes with no adverse event. The unspecified number of patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 24-Feb-2026, the patient received punctured poliomyelitis vaccine (inactivated) (IPOL) Suspension for injection (dose, route, site strength was: unknown) for immunization (Product storage error), and latency: same day) (batch: Y1D03P1, expiry: 31-Aug-2027)]. She said that she did not realize that the door was propped open. Max/low temperature reached: 8.1° to 9.1°C Duration: 3 hours '&' 22 minutes Previous Excursion? Yes. On 17Feb2026: Cold excursion, 1.5°- 1.8°C for 1 hour '&' 02 minutes Human error? Yes. Administered post-excursion? Yes. She said that on 24Feb2026, a dose was given to a patient after the cold excursion back on 17Feb2026.Does extended stability data cover the excursion? No. Advanced practice registered nurse sought advice regarding re-administration of the dose following the first excursion. Action taken: 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. Additional information received on 27-Mar-2026 from a practice registered nurse: Patient details added. Text amended accordingly
Comments: NONE