Reporte zur Charge U8135AE

Symptomtext

some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event; Initial information received on 29-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 70 years old female patient and pharmacist reported that Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Oct-2023, the patient received a 0.7 ml of dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: high dose, frequency: once, expiry date: unknown and lot U8135AE) via unknown route in unknown administration site as immunization and some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event (incorrect dose administered) (same day latency). 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.