Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 4 | U8232AA | OT / LL |
3 year child received Adacel with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old male patient who received Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A vaccine INACT (Havrix) for Immunisation. On 07-Apr-2025, a 3 year old male patient received a 0.5ml (dose 4) of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection in pre-filled syringe standard strength, frequency-once (lot U8232AA, expiry date-31-May-2026) via intramuscular route in the left thigh for Immunization with no reported AE (product administered to patient of inappropriate age) (latency-same day). Reportedly- Their office inadvertently gave the Adacel to a child, ADACEL, which is indicated for 10 years to 64 years old. 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.
HAVRIX