Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK356AA | IM / RL |
inadvertently administered only the Hib component of the PE NTACEL vaccine, which was reconstituted with sterile water with no AE; Initial information received on 10-Apr-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 15-month-old male patient who was inadvertently administered only the Hib component of the DIPHTHERIA/TETANUS/5 HYBRID AC.PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE (PENTACEL) vaccine, which was reconstituted with sterile water with no adverse event (AE). The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant vaccine was the pneumococcal 20 vaccine. On 06-Feb-2026, the patient was inadvertently administered only the Hib component of the DIPHTHERIA/TETANUS/5 HYBRID AC.PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE-520 powder and suspension for suspension for injection (dose: 0.5 mL) (batch number: UK356AA, expiry date: 28-Feb-2027) (strength: unknown), which was reconstituted with sterile water (dose: 0.5 mL) (dose: 4) via intramuscular route in right vastus lateralis for immunization (Immunisation) (Single component of a two-component product administered, 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.
Comments: NONE