Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK046AA | OT / LL |
incorrect medication is PENTACEL because the patient only needs DTaP with no reported adverse event; incorrect medication is PENTACEL because the patient only needs DTaP with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old male patient who was incorrectly administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] because the patient only needs DTAP with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) both for Immunisation. On 20-Aug-2025, the patient received 0.5 ml of dose 1 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- standard, expiry date- 31-AUG-2025 and lot UK046AA) via intramuscular route in the left vastus lateralis for Immunization; the patient only needs dtap with no reported adverse event (wrong product administered) (extra dose administered) (latency- same day). Reportedly, the patient received an extra dose of DTaP. 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.
DAPTACEL; Vaxneuvance