Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (UNKNOWN) | 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 92.25 hours were not engaged 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 involves patient of an unknown age and unknown gender and it was reported temperature excursion of diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine due to refrigerator, wi-fi data loggers were not activated and the usb data loggers for total 92.25 hours were not engaged with no reported adverse event. The vaccine was administered post-excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Jul-2025, the patient received an unknown dose of suspect diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (formulation; strength; lot number; expiry date not reported) via intramuscular route in unknown administration site for Immunisation and there had been temperature excursion of vaccines due to refrigerator, wi-fi data loggers were not activated and the usb data loggers for total 92.25 hours were not engaged with no reported adverse event (product storage error) (unknown latency). Information regarding batch number and expiration 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.