Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK333AA | OT / LL |
only the Hib component (green top) was administered with a sterile diluent (0.7 mL sterile water) and it was not mixed together with the DTaP/IPV liquid component (blue top) with no reported adverse event; Initial information received on 13-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient who was administered only the hib component (green top) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with a sterile diluent (0.7 ml sterile water) and it was not mixed together with the dtap/ipv liquid component (blue top) 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 Rotavirus vaccine; Influenza vaccine; Hepatitis B vaccine; and Pneumococcal vaccine all for Immunisation. On 12-JAN-2026 the patient was administered dose 2 of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Powder and suspension for suspension for injection) (lot: UK333AA; expiry date: 30-Sep-2026) and only the hib component (green top) of with a sterile diluent (0.7 ml sterile water) and it was not mixed together with the dtap/ipv liquid component (blue top) with no reported adverse event (single component of a two-component product administered) (latency: same day) via intramuscular route in the left vastus lateralis for Immunisation. 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.
Rotavirus vaccine; Influenza vaccine; HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE