Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
patient received vaccine which was 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 event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to this US-SA-2025SA202579. This case involves a 56 years old and unknown gender patient who received Diphtheria, Tetanus And Acellular Pertussis Vaccine, post 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 event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Jun-2025, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown, expiry date, lot not reported) via unknown intramuscular route in unknown administration site for prophylactic vaccination (Immunization) and temperature excursion occurred 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 event (Product storage error) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Reportedly, all patients were contacted and recommended to re-vaccinated due to temperature excursion. Human error was involved. The extended stability data did not cover the excursion. 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:master case