Symptomtext
was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp. This case involves a 3-month-old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) 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 7V (CRM197) (Prevnar), rotavirus vaccine live reassort oral 5V (ROTATEQ) and Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) all for Prophylactic vaccination. On 06-Feb-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml once (lot UJ789AA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunisation). On 06-Feb-2023 the patient developed a non-serious was administered pentacel that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day). Action taken: Not applicable. Outcome: Unknown for both the events. 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.
