Reporte zur Charge UT8144A

Symptomtext

patient receiving a double dose of the vaccine with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who received a double dose of the influenza quadrival A-B vaccine [Fluzone QIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for prophylactic vaccination (Immunisation). On 23-Oct-2023, the patient received double doses of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8144A; expiry date: 30-Jun-2024) via intramuscular route in the left and right arm for prophylactic vaccination (Immunisation) (extra dose administered) (latency: same day). 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.