Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK307AB | OT / LL |
patient were administered the hib bottle alone that was mixed with a standard reconstitution solution with no reported adverse event; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient who was administered the HIB bottle alone that was mixed with a standard reconstitution solution with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) VACCINE [Pentacel (Vero)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20); and Hepatitis A vaccine (Hepatitis A) both for Immunisation. On 05-Nov-2025, the patient received a 0.5 ml (1X) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (strength, formulation and expiry date: unknown) (lot:UK307AB) via intramuscular route in the left thigh for immunization. On 05-NOV-2025 the patient was administered the hib bottle alone that was mixed with a standard reconstitution solution with no reported adverse event (product preparation error) (latency: same day). 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.
Prevnar 20; Hepatitis A