Received May 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK196AA | IM / LL |
administration of PENTACEL to a 5 year old patient, instead of the intended dose of kinrix with no reported adverse event; Initial information received on 02-Mar-2026 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 5 years old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel] instead of kinrix with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s), family history, and concomitant medications were not provided. On 27-Feb-2026, the patient administered 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 (1x) via intramuscular route (batch number: UK196AA, Expiry date: 31-Mar-2026) in left thigh for immunization instead of kinrix (Wrong product administered) (latency: same day). No adverse event was reported. 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 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
Proquad