Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Exposure via eye contact, Ocular hyperaemia, Syringe issue, Underdose
Clinical narrative: Eye is red; Full dose not administered; Some landed in the patient's eye; Leaking syringe/the vaccine squirted out; This spontaneous case was received on 31-Aug-2020 from pharmacist via agency (reference number: SEQW20-01079) with additional source received on 02-Sep-2020 (being processed together) and concerned an 84-year-old, female patient.   The patient's concurrent condition included high blood pressure. The patient's concomitant medications included lisinopril, metoprolol and HCTZ (hydrochlorothiazide), all used for unreported indications.   On 31-Aug-2020, while administering Fluad Quadrivalent vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, route of administration: intramuscular, anatomical location: deltoid and dose: not reported] for an influenza prophylaxis, the vaccine squirted out and hit the patient in the eye (explicitly coded as 'Accidental exposure to product'). The batch number reported was 279794 and expiration date 29-May-2020.  It was reported that vaccine started to leak out before the shot was done and that the full dose was not administered (explicitly coded as 'Incomplete dose administered' and 'Syringe leak').   On the same day, after receiving Fluad Quadrivalent vaccine, the patient's eye was red. The patient was not treated with any medication.  At the time of initial reporting on 31-Aug-2020, the patient had not recovered from the event of 'eye redness'.  The reporter did not provide a causality assessment.  This case has been entered onto Seqirus' manufacturing quality assurance tracking database and allocated reference number.  Quality Assurance investigation for this product complaint concluded that the root cause of this event was most likely due to user handling which led to leaking from the luer lock. A contributing factor for this event was the complexity of the safety needle used for administration. In review of this complaint it was determined there was no manufacturing fault that led to the leaking luer lock during administration. There was no requirement for any market action based on all information received, as there was no patient safety risk and the overall defect rate for leaking luer locks is two Defect/Million Syringes distributed.   This case is linked to case 202004293 (the same reporter).  Additional information received on 16-Oct-2020 from Product Technical Complaint (PTC) group: Quality Assurance Investigation Results were provided. Indication re-coded from 'influenza prophylaxis' to 'influenza immunisation'. Event 'Exposure via eye contact' deleted. The narrative was amended accordingly.   Company comment: Ocular hyperaemia along with multiple medication errors and device issue was associated with the use of the suspect product Fluad Quadrivalent. Reportedly, during administration of the product, the vaccine squirted out and hit the patient in the eye. The patient's concurrent conditions included high blood pressure and concomitant medications included lisinopril, metoprolol and HCTZ (hydrochlorothiazide) - all for unknown indication. With information presented, ocular hyperaemia is assessed as not related to the vaccine substance. For reported special situation (incorrect dose administered, accidental exposure to product and syringe leak) causality is assessed as not related per company conventions.; Sender's Comments: Ocular hyperaemia along with multiple medication errors and device issue was associated with the use of the suspect product Fluad Quadrivalent. Reportedly, during administration of the product, the vaccine squirted out and hit the patient in the eye. The patient's concurrent conditions included high blood pressure and concomitant medications included lisinopril, metoprolol and HCTZ (hydrochlorothiazide) - all for unknown indication. With information presented, ocular hyperaemia is assessed as not related to the vaccine substance. For reported special situation (incorrect dose administered, accidental exposure to product and syringe leak) causality is assessed as not related per company conventions.