Symptomtext
Patient was suppose to receive DAPTACEL, ACTHIB, and PREVNAR 13, but instead received PENTACEL, ACTHIB, and PREVNAR 13, with no reported adverse event; received two doses of ACTHIB and an extra dose of IPV component, with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from nurse, consumer/non-healthcare professional and physician via Media Information (under reference 00796837). This case involves a 17 months old female patient who was suppose to receive DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), but instead received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)], ACT-HIB and PREVNAR 13 (wrong product administered) and received two doses of ACT-HIB and an extra dose of ipv component [extra dose administered]. The patient's past vaccination(s) included IPV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. The IPV series was completed in September 2020. The patient's medical history, past medical treatment(s) and family history were not provided. On 04-Oct-2021, the patient received concomitant medication, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination. On 04-Oct-2021, the patient received a 0.5 mL fourth dose of suspect PENTACEL (VERO) (Total, lot UJ416AAA and expiration date: 12-Mar-2022) via intramuscular route in the right thigh and on the same day, she received a dose of suspect ACT-HIB (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered and extra dose administered (same day latency). It was reported "Nurse would like safety information of receiving extra doses and would like to know how this affects the patients booster dose of IPOL?" At time of reporting, no adverse event 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. There will be no information available on the batch number for the suspects DAPTACEL and ACT-HIB.