Reporte zur Charge U75968B

Symptomtext

patient was given a third dose of Menquadfi (with no reported adverse event); patient was given a third dose of MENQUADFI instead of Bexsero (with no reported adverse event); Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16-year-old male patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] (with no reported adverse event) and patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] instead of Bexsero. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 24-Jul-2023, the patient received a dose 3 of 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: unknown) (lot: U75968B, expiry date: 14-Mar-2025) via intramuscular route in the left deltoid for Immunization and unknown dose of suspect BEXSERO not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for immunization. On 24-JUL-2023 the patient was given a third dose of menquadfi (with no reported adverse event) (extra dose administered) and patient was given a third dose of menquadfi instead of bexsero (with no reported adverse event) (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO. Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) was not applicable. Outcome: 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 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.