Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U7665BA | OT / LA |
administered with ADACEL when the patient was just 9 years old with no reported adverse event; Initial information received on 11-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old female patient who was administered with 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. At the time of the event, the patient had ongoing Skin laceration. On 06-Oct-2023, the patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 04-MAR-2025 and lot U7665BA) via intramuscular route in the left arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). It was reported that, "the patient had laceration on her left foot so she was given with ADACEL in urgent care. They gave the shot and treated the wound. She asked if they will require another shot when the child turns 11 year old or wait after 10 years." 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.
Laceration of foot