Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK305AB | OT / RL |
they administered only the lyophilized acthib component of the vaccine, which was mixed with sterile water with no reported adverse event; Initial information received on 30-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 7 months old male patient who was administered only the lyophilized ACT HIB component of the vaccine, which was mixed with sterile water with no reported adverse event after 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 Hepatitis B Vaccine rHBsAg (yeast) (Recombivax hb); Pneumococcal Vaccine Conj 15v (CRM197) (Pneumococcal vaccine conj 15v (CRM197)) and Rotavirus vaccine live reassort oral 5v (Rotateq) all for Immunisation. On 08-Oct-2025, the patient received a dose 3 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength: unknown) at the dose of 0.5 ml (once) (lot: UK305AB, expiry date: 30-Sep-2026) via intramuscular route in the right thigh for immunization. On 08-OCT-2025 the patient developed a non-serious event "They administered only the lyophilized acthib component of the vaccine, which was mixed with sterile water with no reported adverse event (single component of a two-component product administered) (latency: same day). It was reported "They administered only the lyophilized ACTHIB component of the vaccine, which was mixed with sterile water. They asked whether that could be "counted as a valid hib vaccine. "RN confirmed that the liquid DTaP-IPV component was present in the packaging and simply "overlooked." 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.
Recombivax hb; Pneumococcal vaccine conj 15v (CRM197); Rotateq