Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
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; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to US-SA-2025SA202579 (Master case). This case involves a 56 years old and unknown gender patient who received Diphtheria, Tetanus And Acellular Pertussis Vaccine that had 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. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The excursion was from 21-May-2025 to 26-Jun-2025 with 56°F (Degree Fahrenheit) for 4 hours, on 25-Jun-2025 with 32.2°F for 2.25 hours, on 11-Jul-2025 with 48.8°F for 0.75 hours and 10-Jul-2025 to 14-Jul-2025 for 87.5 hours but no temperature data with total hours 92.25 hours, if included 87.5 hours if it was a hot excursion it would only be 4.75 hours cumulatively for cold excursion. On 30-Jun-2025, the patient received a dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer after excursion (lot number, form, strength, dose and expiry not reported) via intramuscular route in unknown administration site as prophylactic vaccination with no adverse event (product storage error). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly, patient was contacted and recommended to be revaccinated again. Human error was yes, as the refrigerator was new, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged. 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.; Sender's Comments: US-SA-2025SA202579:Master Case