Symptomtext
child received PENTACEL as well as ACT-HIB on the same day, with no reproted adverse event; Initial information received on 08-Dec-2021 regarding an unsolicited valid non-serious case from nurse via Agency (under reference 00890410). This case involves a 4 months old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and HIB (PRP/T) VACCINE [ACT-HIB] on the same day (extra dose administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as concomitant vaccines. On 08-Dec-2021, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (Oral solution, Lot: UJ425AA and expiration date: 21-May-2022) via intramuscular route in the left thigh and dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiration date: not reported) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to extra dose administered (same day latency). It was reported "Nurse calling to report that a 4 month old child received PENTACEL as well as ACT-HIB on the same day. Caller is asking what to do." 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 suspect PENTACEL.