Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8122AA | OT |
temperature excursion: adacel was administered afterwards with no reported adverse event; Initial information received on 26-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient with unknown age and gender who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] and there was temperature excursion: negative disposition with no reported 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot U8122AA, expiry date 30-Apr-2026 and U8366AA, expiry date : 31-Jan-2027, strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and was administered afterwards with no reported adverse event (poor quality product administered) (latency same day). Reportedly, the temperature reached as a low of 31.9F for 2 hours & 18 mins and 46.9F for an hour due to someone changing the temperature range of the fridge. There was no previous excursion. 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.