Reporte zur Charge U800CA

Symptomtext

medication leaked on the patient with no reported adverse event; patient and half of it ended up on the patient's leg with no reported adverse event; half of it ended up on the patient's leg with no reported adverse event; Initial information received on 01-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient on whom Influenza Quadrival A-B Vaccine [Fluzone QIV] medication leaked and half of it ended up on the patient's leg 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination; HIB VACCINE (HIB) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination. On 01-Dec-2023, the patient was receiving a dose 1 with dosage 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot U800CA, Expiry date: 30-Jun-2024 with strength unknown) via intramuscular route in right leg as immunization which leaked on the patient and half of it ended up on the patient's leg with no reported adverse event (incorrect dose administered) (accidental exposure to product) (exposure via skin contact) (Latency: same day). It was reported "The nurse is asking if the patient needs to get a second dose. The nurse reported that while she was injecting, the patient moved away and the medication leaked on the patient. The nurse stated that she cleaned it up with an alcohol swab and wiped the patient. The nurse was not sure if the patient received half or less than half of the dose." 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.