Reporte zur Charge UJ3999AAC

Symptomtext

The dose of ActHIB was reconstituted with sterile water instead of the diluent provided; Initial information was received on 13-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00680213). This case involves a 12-month-old male patient who experienced the dose of HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the diluent provided (product preparation issue). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot number: UJ3999AAC, expiry date: 02-Oct-2021] via an unknown route at left thigh for prophylactic vaccination (product preparation issue) (latency: 1 day). It was a case of actual medication error due to inappropriate reconstitution technique. At the time of reporting, no adverse event was reported. It was reported that "A patient received ActHIB on 08Jul2021 in the left thigh. The dose of ActHIB was reconstituted with sterile water instead of the diluent provided. Dose # if series #4--This was the first HIB the patient received that was ActHIB alone. Doses #1 through #3 of HIB received were as part of Pentacel." 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.