Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
Temperature excursion of vaccines due to refrigerator, Wi-Fi data loggers were not activated, and the USB dataloggers 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 other health professional. This case involves Adult and unknown gender patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after temperature excursion of vaccines due to refrigerator, wi-fi data loggers were not activated, and the USB (Universal Serial Bus) dataloggers 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 an unknown date, the patient received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength, dose, batch and expiry date unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested On an unknown date temperature excursion of vaccines due to refrigerator, wi-fi data loggers were not activated, and the usb dataloggers for total hours 92.25 hours were not engaged with no adverse event (product storage error) (unknown latency). Reportedly, patients were contacted again and recommended to re-vaccinate again. Action taken- 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.