Received Feb 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK346AA | OT / LL |
Only lyophilized ACTHIB component reconstituted with sterile water/DTaP-IPV component was present in the package, but that it was not used with no adverse event; Initial information received on 09-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who received only lyophilized acthib component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] reconstituted with sterile water/dtap-ipv component was present in the package, but that it was not used with no 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 INACT (HAVRIX) and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)) for Immunisation. On 04-Feb-2026, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK346AA and expiry 31-Jan-2027) only lyophilized acthib component reconstituted with sterile water/dtap-ipv component was present in the package, but that it was not used with no adverse event (single component of a two-component product administered) (Latency sane day) via intramuscular route in the left thigh for immunization. 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.
HAVRIX; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)