Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL was exposed to a temperature of 9.5C for a total duration out of range of 10 minutes and was administered to patient(s) post temperature excursion with no reported adverse event; IPOL was exposed to a temperature of 9.5C for a total duration out of range of 10 minutes and was administered to patient(s) post temperature excursion with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 years old male patient who stated ipol was exposed to a temperature of 9.5c for a total duration out of range of 10 minutes and was administered post temperature excursion with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history included Hepatitis B immunisation and Polio immunization. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Mar-2023, the patient received an unknow dose of suspect ipv (VERO) (Suspension for injection) (lot: V1B90M/VIB901M; expiry date: 20-Jun-2024) (strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in Mar-2023, the patient developed a non-serious event of ipol was exposed to a temperature of 9.5c for a total duration out of range of 10 minutes and was administered post temperature excursion with no reported adverse event (product storage error) and (poor quality product administered) (unknown latency) following the administration of ipv (VERO).  It was reported, "Nurse reporting a temperature excursion due to the refrigerator door was left open at their facility. The highest temperature it reached was 9.5C for a total duration out of range of 10 minutes. The unopened products were: Daptacel, Pentacel, Quadracel, Vaxelis, Menquadfi, Tenivac, Adacel, Ipol (open and closed). Nurse calling for stability. Extended stability data covers unopened products with the exception of the open Ipol. Nurse requests for stability information be emailed. Nurse said some products may have been administered post temperature excursion since it happened in the last month. Informed Nurse the only product that she would need to check if any patients were administered was the open Ipol. Nurse said she will look back at the records and will call back to inquire about revaccination."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  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 guidelines. 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 was received on 11-Apr-2023 from other health professional: Classification, Patient Age, Age group, Medical history were added. Text amended accordingly.