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 was linked with other cases, US-SA-2025SA283520 and US-SA-2025SA283466. This case involves a 16 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only received the diluent and not the vaccine 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) and 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), both for Immunisation. On 13-Sep-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK226AA and expiry date 31-Aug-2026 via intramuscular route in the left thigh for Immunization but only received the diluent and not the vaccine with no reported Adverse event (Single component of a two-component product administered) (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.; Sender's Comments: US-SA-2025SA283520: US-SA-2025SA283466:
PREVNAR 20; VAXELIS