Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK227AB | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
received DTap and PENTACEL with no reported adverse event; patient was supposed to get acthib as well but was given pentacel instead with no reported ae; PENTACEL and ACTHIB looked very similar in packaging; Initial information received on 25-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], patient was supposed to get HIB (PRP/T) vaccine [ACT-HIB] as well but was given pentacel instead and pentacel and ACT-HIB looked very similar in packaging with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown, expiry date- 31-Oct-2026 and lot- UK227AB) and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength, expiry date and lot not reported) (extra dose administered), patient was supposed to get HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date and lot not reported) as well but was given pentacel instead (wrong product administered) and pentacel and ACT-HIB looked very similar in packaging (product packaging confusion) for prophylactic vaccination with no reported adverse event (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.