Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201 | OT |
Opened IPOL have been administered after the excursion occurred as the fridge in which the product was stored was too warm and product deemed not viable with no reported adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA313446 (master case). This case involves a 6 years old male patient who had been administered opened IPV (VERO) [IPOL] after the excursion occurred as the fridge in which the product was stored was too warm and product deemed not viable 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 had been administered a dose of 0.5 (units unspecified) of IPV (VERO) (Suspension for Injection) (lot: Y1A201; expiry date: 31-Jan-2027) after the excursion occurred as the fridge in which the product was stored was too warm and product deemed not viable with no reported adverse event (poor quality product administered) (latency: same day) via intramuscular route in unknown administration site for Immunization. It was reported, "Office manager then confirmed that if the punctured IPOL was administered after the excursion occurred, that would not be counted as valid and should be repeated. Cause:Older refrigerator and lots of vaccines Max/Low Temperature reached: 51.3? Duration out of labelled range: half an hour Previous excursion: at 47.5°F half an hour at 46.3? for 15 minutes Total duration of excursion: 1 hour. No Human error. New sensors for data loggers for fridge was installed." 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.; Sender's Comments: US-SA-2025SA313446: US-SA-2025SA325307: