Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 1 | — | OT |
administration of ADACEL to patient under 10 years of age with no reported adverse event; Initial information received on 22-Dec-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 8 years old female patient who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel],with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received 0.5mL(dose 1) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (frequency once, strength standard) (lot number, expiry date not reported) via intramuscular route in the deltoid nos (not otherwise specified) for Immunisation, with no reported adverse event (product administered to patient of inappropriate age) (latency same day). It was repotted "Pharmacist stated that they had 2 patients which were administered to Adacel which were under 10 years of age. They wanted to inquire if there was an issue if the patients have been administered with 1 dose of Adacel under the age of 10, since there are different information from the package and and if it is advisable to continue using Adacel for their second dose". Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken with 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.