Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
received an extra dose of TDap described as a consumer got a dose of Adacel with no adverse event; Initial information received on 11-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult male patient who received an extra dose of tdap described as a consumer got a dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and an extra dose of tdap described as a consumer got a dose of adacel with no adverse event (extra dose administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, the Pharmacist reported that the computer system alerted that the consumer was due for a TDap and it was not until after the dose was given was it seen that the consumer had the dose on an unknown date in 2023. 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.