Reporte zur Charge UT7407AM

Symptomtext

a staff member administered FLUZONE QIV NP to a 10 week old patient instead of Prevnar with no reported adverse event; FLUZONE QIV NP is not approved for use in patients less than 6 months old; and admintered FLUZONE QIV NP to 10 week old patients with no reported adverse event; Initial information received on 18-Mar-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a 2 months old and unknown gender patient who was administered Influenza quadrivaL A-B vaccine [Fluzone QIV] instead of Prevnar which is not approved for use in patients less than 6 months old with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza quadrivaL A-B vaccine (with an unknown formulation, strength, dose and route) (lot number: UT7407AM and expiry date: 30-Jun-2022) in unknown administration site for prophylactic immunization. On an unknown date the patient was administered Influenza quadrivaL A-B vaccine instead of Prevnar with no reported adverse event (wrong product administered) and Influenza quadrivaL A-B vaccine is not approved for use in patients less than 6 months old with no reported adverse event (product use issue). Action taken 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.