Sex: F
Vaccine: FLUA4
Symptoms: Exposure via eye contact, Syringe issue, Underdose
Clinical narrative: When the vaccine was given it fell out of a side and hit a patient's eye; Had a faulty syringe or needle tip as Vaccine fell out of a side when given; No full dose was administered as vaccine fell out of a side when given; Vaccine fell out of a side/ came out at an angle when given and hit a patient's eye; This spontaneous case was received on 15-Nov-2023 from a pharmacist via agency (reference number: SEQW23-04297) with additional information received on 22-Nov-2023 from Seqirus' manufacturing quality assurance department (being processed together) and the concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.   On 15-Nov-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B. The device associated with Fluad Quadrivalent was Luer Lok Syringe. The batch number reported was 374228, and the expiry date was 30-Jun-2024. As reported, the syringe or needle tip had a fault, so when the vaccine was given, it fell out of a side and hit a patient's eye (explicitly coded as 'Syringe leak', and 'Accidental exposure while administering drug'). Prior to vaccination, there were no signs of damage on the syringe or the needle, but the needle appeared tightly attached. The plunger was depressed, and the needle shield was not in place. While administering the dose, the defect was noticed, but the reporter could not tell where the leakage was, just that it came out at an angle where it made contact with the patient's eye. As reported, a full dose was not administered (explicitly coded as 'Incomplete dose administered'). They tried with a different needle, and it was reported that it was fine after the new needle was used.   On the same date, the patient recovered from the event of 'eye injury'. As reported, the patient was 'fine by then'. Treatment measures taken included calling the Poison Center.   This case has been entered into Seqirus' manufacturing quality assurance tracking database and the allocated reference number was QE-021658.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with the suspect product Fluad Quadrivalent. The device associated with Fluad Quadrivalent was Luer Lok Syringe. The syringe had a fault, causing the needle to fall out and hit a patient's eye during vaccination. There were no signs of damage before use, but the needle appeared tightly attached. The plunger was depressed, and the needle shield was not in place. The defect was noticed during administration, but the reporter couldn't identify the leakage source. A full dose was not administered. Causality for eye injury is assessed as not related to the suspect vaccine, as it was a consequence of faulty syringe, while it is possibly related to luer lok syringe. Syringe leak, incomplete dose administered, and accidental exposure to product are assessed as not related to the suspect vaccine, however related to Luer Lok Syringe.; Sender's Comments: A patient of an unreported age was vaccinated with the suspect product Fluad Quadrivalent. The device associated with Fluad Quadrivalent was Luer Lok Syringe. The syringe had a fault, causing the needle to fall out and hit a patient's eye during vaccination. There were no signs of damage before use, but the needle appeared tightly attached. The plunger was depressed, and the needle shield was not in place. The defect was noticed during administration, but the reporter couldn't identify the leakage source. A full dose was not administered. Causality for eye injury is assessed as not related to the suspect vaccine, as it was a consequence of faulty syringe, while it is possibly related to luer lok syringe. Syringe leak, incomplete dose administered, and accidental exposure to product are assessed as not related to the suspect vaccine, however related to Luer Lok Syringe.