Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK167AA | OT / RL |
administration of PENTACEL at an earlier than the recommended scheduled time with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] earlier than the recommended scheduled time 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) [pneumococcal vaccine Conj 20V (CRM197)]; and diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (Vero), tetanus vaccine toxoid (pediarix)on 16-Jan-2025 both for Immunisation. On 28-Jan-2025, the patient received 0.5ml (Dose 1) (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Suspension for injection, Strength standard and lot UK167AA with expiry date 31-Oct-2025 via intramuscular route in the right thigh for Immunisation earlier than the recommended scheduled time with no reported adverse event (inappropriate schedule of product administration) (Latency Same day). Reportedly, Caller confirmed that the patient received Pentacel approximately one month too early. Treatment received: no. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197); PEDIARIX