Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK043AA | OT |
temperature excursion of vaccines due to refrigerator, Wi-Fi data loggers were not activated, and the USB data loggers were not engaged, total hours 92.25 hours with no adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [pentacel (vero)] after temperature excursion of vaccines due to refrigerator, wi-fi data loggers were not activated, and the USB data loggers were not engaged, total hours 92.25 hours with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jul-2025, the patient received unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (Unknown strengt) with lot UK043AA and expiry date 31-Aug-2025 via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event (product storage error). Reportedly, Reportedly, Max/low temperature reached: 21-May-2025 to 26-Jun-2025: 56 degree Fahrenheit for 4 hours, 25-Jun-2025: 32.2-degree Fahrenheit for 2.25 hours, 11-Jul-2025: 48.8 degree Fahrenheit for 0.75 hours, 10-Jul-2025 to 14-Jul-2025: 87.5 hours: no temperature data, total hours 92.25 hours. This excursion occurred due to a human error and product was not 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.