Received Mar 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK345AB | IM / LL |
the HIB component was reconstituted with sterile water and not the DTAP IPV solution and was inadvertently administered to a patient with no reported adverse event; Initial information received on 11-Mar-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves a 4-month-old female patient was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but only HIB component which was reconstituted with sterile water and not the DTAP-IPV solution was inadvertently administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. The patient's past vaccination(s), included Diphtheria vaccine toxoid, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid [Vaxelis] Concomitant medication(s) included Pneumococcal vaccine conj 20v (CRM197) [PCV-20], and Rotavirus vaccine live oral 1v [Rotarix] both for Prophylactic vaccination [immunisation]. On 10-Mar-2026, the patient received 0.5ml (Dose 1) of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (once), Powder and suspension for suspension for injection (strength: standard) batch: UK345AB, expiry date: 31-Jan-2027 via intramuscular in Left Vastus Lateralis for immunization but the HIB component was reconstituted with sterile water and not the DTAP-IPV with no reported adverse event (Single component of a two-component product administered) (latency: same day). It was reported that, "It was supposed to be the second dose however the provider did VAXELIS as first dose so patient can receive HepB. This was the first time the patient received Pentacel." 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.
Pneumococcal vaccine conj 20v (CRM197); Rotateq