Reporte zur Charge UJ458ABA

Symptomtext

patient received only the solution portion of the Pentacel/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case received from an other health professional via the Medical Information under reference number - 00708879. This case involves a 3 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but only with solution portion (Act-HIB) (Product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination. On 22-Jul-2021, the patient received first dose 0.5 mL (standard; total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ458ABA and expiry date 21-May-2022) via an intramuscular route at the left thigh for prophylactic vaccination. It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day). It was reported that "HCP (Healthcare Professional) stated PENTACEL come with two components and she didn't combine both. HCP stated she gave the solution, Act-HIB and wanted to know how she can fix the error. HCP wanted to know if she can reconstitute the powder with saline and give that or redo the PENTACEL shot. Caller states that she administered a Pentacel and she may have be rushed or was distracted but she only gave the solution portion of the vaccine". At the time of report, no adverse event reported. Outcome of event was unknown. 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 and Regulatory Authority 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.