Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK216AB | OT / RL |
administered PENTACEL without reconstituting the HIB with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without reconstituting the HIB 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 Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance); and rotavirus vaccine live reassort oral 5V [Rotateq] as both for Immunisation. On 17-Jul-2025, the patient received 0.5 ml of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date- 31-JUL-2026 and lot UK216AB) once via unknown route in the right vastus lateralis for Immunization without reconstituting the HIB with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, caller was looking for any guidance and asked if they could give the patient ACTHIB to make up for the HIB. 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.
Vaxneuvance; ROTATEQ