Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK364AA | OT / LL |
received only the dtap/ipv component of pentacel. the hib part was not reconstituted and given to the patient with no reported adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who had received only the dtap/ipv component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)]. the hib part was not reconstituted and given to the patient 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) for Immunisation. On 26-Nov-2025, the patient received a 0.5 ml (dose 4) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength: standard, frequency: once, expiry date: 31-Mar-2027 and lot UK364AA via intramuscular route in the left thigh as Immunization and only the dtap/ipv component of pentacel. the hib part was not reconstituted and given to the patient with no reported adverse event (single component of a two-component product administered) (latency: same day). Reportedly, 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.
Vaxneuvance