Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 1 | — | OT |
Received 2 doses of ADACEL about 5 months apart, with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who received 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] about 5 months apart, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Apr-2025, the patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot, expiry date, strength not reported) via unknown route in the unknown site and on 03-Sep-2025, 0.5mL (dose 2) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot U8670BA, expiry date 31-Aug-2027, strength standard and frequency once) via intramuscular route in the right deltoid and for Immunisation and 2 doses received about 5 months apart, with no reported adverse event (Extra dose administered) (latency same day). Reportedly, they received one yesterday on 03-Sep-2025, but it was found out they also received one on 02-Apr-2025 that was not documented properly and the nurse said that the patient had no adverse reaction. No other immunizations. 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.