Symptomtext
patient was meant to receive Pediarix and a standalone HIB vaccine, but PENTACEL was given in error with no reported adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 2 months old male patient who experienced patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix). On 11-Jan-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of 0.5ml lot UJ664AAA at expiry date of 4-May-2023 via intramuscular route in left leg Immunization. On 11-Jan-2023 the patient developed a non-serious event of patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event (wrong product administered) (latency : same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient was meant to receive Pediarix and a standalone HIB vaccine, but Pentacel was given in error with no reported adverse event). At time of reporting, the outcome was Unknown for the event patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event. 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.