Reporte zur Charge U8130BA

Symptomtext

1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event; 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event; Initial information was received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old female patient who received dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event after receiving influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] and influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; hepatitis a vaccine (HEPA [hepatitis a vaccine]) for Prophylactic vaccination; HIB VACCINE (HIB) for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 07-Sep-2023, the patient received a dose 1 of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8130BA, Expiry date : 30-Jun-2024, formulation, strength was unknown) via intramuscular route in right leg for Immunization and unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (expiry date, strength, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). On 07-Sep-2023 the patient developed a non-serious event of 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event (wrong product administered and product administered to patient of inappropriate age) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event and was Unknown for the event 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event. 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.