Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | 4 | U8623AA | OT / LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
15-month-old patient was inadvertently administered the Quadracel prefilled syringe vaccine, rather than the intended Pentacel vaccine as the fourth dose of the series, with no reported adverse event; 15-month-old patient was inadvertently administered the Quadracel prefilled syringe vaccine, rather than the intended Pentacel vaccine as the fourth dose of the series, with no reported adverse event; Initial information received on 08-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was inadvertently administered the Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)], rather than the intended Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] as the fourth dose of the series, 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 07-Jan-2026, the patient inadvertently received 0.5mL (dose 4) of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine, Suspension for injection in Prefilled Syringe (lot U8623AA, expiry date 31-Aug-2027 and strength not reported) via intramuscular route in the left vastus lateralis for Immunisation rather than the intended pentacel vaccine as the fourth dose of the series, with no reported adverse event (wrong product administered, product administered to patient of inappropriate age) (latency same day). It was reported "healthcare professional asked for any information on efficacy and safety since Quadracel is not approved for patients younger than 4 years of age." 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.
Prevnar 20