Reporte zur Charge N1L47

Symptomtext

dosing schedule needs to be re-started due to deviation from vaccination schedule; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 23 year old female patient who was vaccinated with first and second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot N1L47 and expiry date 23 May 2021) via unknown route in unknown administration site for prophylactic vaccination, first dose on 07 Jan 2021, second dose on 14 Jan 2021 (inappropriate schedule of product administration). The medical history, medical treatment(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to inappropriate schedule of product administration (latency unknown). Patient presenting for 3rd dose of IMOVAX for pre exposure. Caller reporting patient was at 33 days since first dose. Caller with question on whether dosing schedule needs to be re-started due to deviation from vaccination schedule. Additional Description of event Adverse events :RN with patient presenting for 3rd dose of IMOVAX for pre-exposure. Since first dose. 1st dose: 07Jan2021 2nd dose: 14Jan2021. At the time of report, no 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 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.