Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | 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 other health professional. This case is linked to 2025SA202579 This case involves a 43 year old and unknown gender patient who was recommended to be re-vaccinated due 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 after receiving Diphtheria, Tetanus And Acellular Pertussis Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jul-2025, the patient received an unknown dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer (lot number, formulation, strength and expiry date-unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) recommended to be re-vaccinated due 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 (Product storage error) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.