Received Jan 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | 4 | U8623AA | OT / RL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
an 18-month-old patient was inadvertently administered QUADRACEL when they meant to administer Pentacel with no reported adverse event; an 18-month-old patient was inadvertently administered QUADRACEL when they meant to administer Pentacel with no reported adverse event; Initial information received on 22-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient who was inadvertently administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] when they meant to administer diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 HIB vaccine, Hepatitis A vaccine; and varicella zoster vaccine (Varicella Vaccine) all for Immunisation. On 22-Jan-2026, the patient received 0.5 ml of Dose 4 of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Suspension for injection (strength- unknown, expiry date- 31-AUG-2027 and lot U8623AA) via intramuscular route in the right thigh for Immunization )] when they meant to administer diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength, expiry date and lot not reported) for prophylactic vaccination (Immunization) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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. Based on data previously received, the following information has been amended: narrative added in the case as requested.
HIB VACCINE; Hepatitis A; VARICELLA VACCINE