Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK305AB | OT / RL |
inappropriate use due to administration of PENTACEL instead of DTaP with no ae; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 months old female patient who had inappropriate administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine (DTAP) with no 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 and HIB vaccine for Immunisation. On 28-Aug-2025 at 11:03 AM, the patient received a 0.5 ml dose (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (Frequency: Once, lot number: UK305AB, expiry date: 30-Sep-2026, strength: standard) via intramuscular route in the right vastus lateralis as immunization instead of dtap with no ae (wrong product administered) (same day latency). Action taken: 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.
Hepatitis a vaccine; HIB vaccine