Symptomtext
A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00772888) and transmitted to Sanofi on 16-Sep-2021. This case involves a 6-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and Accidental overdose). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AB, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day). It was reported "Caller reported by accident, a FLUZONE HIGH-DOSE VACCINE was given to a 6 month old child. Caller wanted to know what she should do from here. Caller states that FLUZONE HIGH DOSE QUADRIVALENT 21-22was given to a six month old at a different location. "What should we watch for safety and side effects?" 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 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.