Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK226AA | OT / LL |
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but they only gave the diluent and not the vaccine with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Immunisation; And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Immunisation. On 05-Sep-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] Suspension for injection (lot UK226AA and expiry date-Aug-2026) via intramuscular route in the left thigh for TB skin test (Skin test) where the patient was only given the diluent and not the vaccine with no reported ae (single component of a two-component product) frequency-once, standard strength, (latency-same day). 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.
VAXELIS; PREVNAR 20