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 with no AE; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. The case is Linked to US-SA-2025SA323532, US-SA-2025SA321569 and US-SA-2025SA313446. This case involves 4 years old male patient (41 cm and 18.594 kg) to whom opened IPV (VERO) [IPOL] have been administered after the excursion occurred with no ae (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 received 0.5 (Units Unspecified) dose of opened IPV (VERO) Suspension for injection (strength, dose unknown) lot Y1A201M expiry date-31-Jan-2027 via intramuscular route in unknown administration site for Immunisation after the excursion occurred with no ae (poor quality product administered) (same day latency). 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. The fridge was too warm and the product was not viable to use after excursion. No Human error". The patient was readministered the product and the same was recognized on 22-Oct-2025. New sensors for data loggers for fridge was installed." 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.; Sender's Comments: US-SA-2025SA313446: US-SA-2025SA323532: US-SA-2025SA321569: