Symptomtext
a patient only received the DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV (DTAP-IPV) portion and not the HIB portion of Pentacel vaccine, due to the two components not being mixed, No AE; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a two months old female patient who received the Diphtheria, Tetanus, AC Pertussis, IPV (DTAP-IPV) portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], due to the two components not being mixed (lot number: UJ496ABA, expiry date: 29-MAY-2022), dose: 0.5 ml, frequency: once, strength: standard via intramuscular route in left thigh for prophylactic vaccination on 21-Jun-2021 (product preparation issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. List concomitant: No other vaccines. It was an actual medication error due to inappropriate reconstitution technique (latency: same day). Potential Product Technique Complain: No, Treatment: The clinic calling the manufacturer and Product used. At the time of reporting on adverse event was reported. 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.