Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Temp. excursion due to human error, Max/low temperature reached 56°F for 4 hours, 32.2°F for 2.25 hours, 48.8°F for 0.75 hours with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case US-SA-2025SA202579 (master case). This case involves Elderly and unknown gender patient and reported temperature excursion of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE due to human error, max/low temperature reached 56°f for 4 hours, 32.2°f for 2.25 hours, 48.8°f for 0.75 hours with no reported adverse event. Vaccine was administered to patient. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot and expiry: unknown) underwent temperature excursion due to human error, max/low temperature reached 56°f for 4 hours, 32.2°f for 2.25 hours, 48.8°f for 0.75 hours with no reported adverse event (Product storage error). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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