Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
The patient received an extra dose of adacel again today with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who administered an extra dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], again today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were provided. On 02-Sep-2025, the patient received an unknown dose 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). On 23-Sep-2025 he also received an additional (dose 7) (0.5 ml dose) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot number and expiry date not reported , strength: standard, frequency: once, via intramuscular route in the left deltoid for immunization, again today with no reported 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,Receptionist called on behalf of healthcare provider to report that a patient received an extra dose of adacel. The patient received a dose of on 02-SEP-2025 and again today, 23-SEP-2025. 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.