Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1D141M | OT |
temperature excursion for IPOL (opened) that reached 63.4F for 1 hour due to an unknown reason or a possible malfunction. Was product administered? YES Was it related to a human error? UNKNOWN with no reported ae; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old male patient who had temperature excursion for Ipv (Vero) [Ipol] (opened) that reached 63.4f for 1 hour due to an unknown reason or a possible malfunction. was product administered? yes was it related to a human error? unknown with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Jun-2025, the patient received a dose of suspect IPV (VERO) (opened); Suspension for injection (lot X1D141M with unknown dose and expiry date) via unknown route in unknown administration site for Immunization; temperature excursion that reached 63.4f for 1 hour due to an unknown reason or a possible malfunction. was product administered? yes was it related to a human error? unknown with no reported adverse event (poor quality product administered). ? Reportedly: she states that they did call the patients to let them know about the event and have them come back into the office. She states that 2 patients were involved. 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.