Symptomtext
vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms; 49-year old female patient received fluzone hd qiv; vaccine came out of the crack in the barrel and sprayed into the patient's eyes; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 49 years old female patient to whom when the nurse administered the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms.. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2023, the 49 years old female patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: standard/0.7 ml, frequency: once, expiry date: not reported and lot number: U8132BA) via unknown route in unknown administration site as immunization (product administered to patient of inappropriate age), vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms (eye irritation) and (accidental exposure to product) (same day latency). Action taken: not applicable. An unknown corrective treatment was received for the event (eye irritation). It was not reported if the patient received a corrective treatment for other events. At time of reporting, the outcome was Unknown for other events and was Recovering / Resolving for the event eye irritation. 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. A Product Technical Complaint (PTC) was initiated on 05-Oct-2023 for FLUZONE HD QIV (lot/batch number: unknown) (Expiration date: unknown). The sample status of the PTC was Not Applicable and the complaint was set in process. Additional information was received on 05-OCT-2023 from quality department: Batch number and PTC details added, text amended accordingly.