Symptomtext
hib component of the pentacel was not mixed and was not given to the consumer with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient and reporter reported hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was not mixed and was not given to the consumer 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 prophylactic vaccination; and rotavirus vaccine live reassort oral 5v (rotateq) for prophylactic vaccination. On 23-Oct-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ861AA) (Expiry date: 30-Mar-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization. On 23-Oct-2023, the reporter reported hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was not mixed and was not given to the consumer with no reported adverse event (product preparation error) (latency: same day). It was reported, LVN called in because the HIB component of the PENTACEL was not mixed and was not given to the consumer. Caller wanted to know about what to do next. Provided the information via SRD, and information was also sent to the caller via email. This inquiry was submitted to PV since the vaccine was given inappropriately without the HIB component. 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.