Symptomtext
the powder portion of Pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event; the liquid portion of Pentacel was not administered with no reported adverse event; Initial information was received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 months old female patient and reported that the powder portion of pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used and the liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was not administered 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 rotavirus vaccine (Rotavirus vaccine) for prophylactic vaccination; pneumococcal vaccine 13v (Pneumococcal 13 valent vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis b vaccine) for Prophylactic vaccination. On 07-Feb-2023, the patient was received the powder portion of the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event (product preparation error) (latency: same day) (lot number: UJ788ABA, expiration date: 18-Sep-2023, dose, formulation, strength: Unknown) via unknown route in the right upper thigh for Immunization (Immunisation) and the liquid portion of pentacel was not administered with no reported adverse event (wrong technique in product usage process) (latency: same day). It was reported that "The powder mixed with sterile water and then administered is lot UJ788ABA. The liquid portion, not administered, is lot U7440BA. She commented that the liquid vial has a smudge on the lot number and she is unsure if the zero is a zero or the letter D. The carton is lot UJ788ABA." No lab data reported. 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 guidelines. 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.