Sex: M
Vaccine: UNK
Symptoms: Accidental exposure to product, Incorrect dose administered, Needle issue, Syringe issue, Vaccination site haemorrhage
Clinical narrative: Patient felt liquid on his arm. It was Fluad's content and blood; Patient felt liquid on his arm. It was Fluad's content and blood; Possible leak from the syringe; Patient felt liquid on his arm. It was Fluad's content and blood; This spontaneous case was received on 14-Oct-2022 from pharmacist via Communications (reference number: SEQW22-04495) with additional information received from Seqirus' manufacturing quality assurance department on 18-Oct-2022 (being processed together) and concerned male patient of an unreported age.   The patient's medical history and concomitant medications were not reported.   On 13-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (dose: 0.5 ml; route of administration and anatomical location: not reported) for prevention of influenza disease. As reported, patient felt liquid on his arm. It was Fluad's content and blood. Pharmacist believe that was possible leak from the syringe but she is not sure (explicity coded as 'Incomplete dose administered' and 'Syringe leak'). The needle did not appear to be tightly attached. The batch number reported was 346381.   The outcome of the events 'vaccination site bleeding' and 'accidental exposure to product' was not reported.   The reporter did not provide a causality assessment.  This case has been entered onto Seqirus's manufacturing quality assurance tracking database and allocated reference number 1111866.   In conclusion of the quality assurance investigation there may be potential component issue in this event. The complaint is specific to the functionality of the syringe/Luer Lok and not the internal drug product, therefore, there is no impact on the safety, identity, potency or purity of the vaccine. The pharmacist stated the fluid may have been due to a leaking syringe. There is no indication from this report that a systemic manufacturing or product fault yet exists. A hold of equipment, facility, process or personnel is not required at this stage of the investigation and there is no investigational testing planned at time of owner evaluation.   The case was assessed as non-serious.  Company comment: A patient of unreported age was vaccinated with the suspect product Fluad Quadrivalent. Reportedly, the patient felt vaccine content and blood on his arm. Pharmacist believed that was possible leak from the syringe, but she was not sure. The needle did not appear to be tightly attached (explicity coded as 'Vaccination site haemorrhage', 'Incomplete dose administered', 'Syringe issue', and 'Accidental exposure to product'). Based on suggestive temporal relationship, causality for the event vaccination site haemorrhage is assessed as possibly related. Vaccination site haemorrhage is also related to luer lok syringe. Causality for the remaining events is assessed as not related to the suspect vaccine but related to luer lok syringe.; Sender's Comments: A patient of unreported age was vaccinated with the suspect product Fluad Quadrivalent. Reportedly, the patient felt vaccine content and blood on his arm. Pharmacist believed that was possible leak from the syringe, but she was not sure. The needle did not appear to be tightly attached (explicity coded as 'Vaccination site haemorrhage', 'Incomplete dose administered', 'Syringe issue', and 'Accidental exposure to product'). Based on suggestive temporal relationship, causality for the event vaccination site haemorrhage is assessed as possibly related. Vaccination site haemorrhage is also related to luer lok syringe. Causality for the remaining events is assessed as not related to the suspect vaccine but related to luer lok syringe.