Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
temperature excursion of vaccines due to refrigerator, Wi-Fi data loggers were not activated, and the USB data loggers were not engaged, or 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 was linked to other case US-SA-2025SA202579. This case involves a 4 months old and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (Vero)] that exposed to temperature excursion due to refrigerator, Wi-Fi data loggers were not activated, and the USB data loggers were not engaged, or 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 01-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 strength) with lot 3CA55C1 and expiry date 30-Aug-2026 via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the suspect exposed to diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection exposed to temperature excursion due to refrigerator, Wi-Fi data loggers were not activated, and the USB data loggers were not engaged, or total hours 92.25 hours with no adverse event product storage error) (unknown latency). Reportedly, Max/low temperature reached: 21-May-2025-26-Jun-2025: 56°F for 4 hours, 25-Jun-2025: 32.2°F for 2.25 hours, 11-Jul-2025: 48.8°F for 0.75 hours, 10- 14-Jul-2025: 87.5 hours: no temperature data - total hours 92.25 hours ? included 87.5 hours if it was a hot excursion. ? excluding the cold excursion on 25-Jun-2025. ? excluding 87.5 hours it would only be 4.75 hours cumulatively (hot excursion). There was no previous excursion. Human error was involved. The extended stability data did not cover the excursion. 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-2025SA202579:master case