Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
data logger reading 46.9 °f but had a technical issue,temperature reading at the bottom of their fridge was at 40 °f,with no reported adverse event; Initial information received on 19-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to IPV (Vero) [IPOL] and the data logger reading 46.9 °F but had a technical issue, temperature reading at the bottom of their fridge was at 40 °F,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 in 2025, the patient received an unknown dose of suspect IPV (Vero), Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization and data logger reading 46.9 °f but had a technical issue, temperature reading at the bottom of their fridge was at 40 °f,with no reported adverse event (poor quality product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. It was reported 'manager advised that these products were administered. Manager called to inquire about the stability of their products after a possible temperature excursion. She explained that their data logger failed for 25 days recording a temperature of 46.9 °F. She further explained that this was due to the glycol bottle that got attached to the inside of the door. She advised that the temperature at the bottom of the fridge was at 40 °F. She just wanted to know the viability of their products at these temperatures. No, previous excursion. The extended stability data cover the excursion: MIS explained that 46.9 °F for 25 days, all the products are not suitable for use, while at 40 °F, the temperature is within range and not considered as an excursion. It was not related to a human error.' 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-2025SA348936: