Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA55C1 | OT |
temperature excursion of vaccines due to refrigerator, Wi-Fi data loggers were not activated, and the USB data loggers for total hours 92.25 hours were not engaged with no adverse; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves Adult and unknown gender patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that was exposed to temperature excursion of vaccines due to refrigerator, wi-fi data loggers were not activated, and the USB data loggers for total hours 92.25 hours were not engaged with no adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jun-2025, the patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine 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 diphtheria-15/tetanus/5 AC pertussis vaccine exposed to temperature excursion due to refrigerator, wi-fi data loggers were not activated, and the USB data loggers for total hours 92.25 hours were not engaged with no adverse (product storage error) (unknown latency). Reportedly, Max/low temperature reached: 21May2025-26Jun2025: 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 25Jun2025. ? 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. 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.; Sender's Comments: US-SA-2025SA202579:mastwr case