Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: Tenderness from injection; Part of the product did not reach the muscle; Part of the product was running down his skin in the arm; The vial stopper felt loose when the syringe was inserted; This spontaneous case from the  was received on 10-Sep-2020 from a consumer via The Agency (reference number SEQW20-01453) and concerned a 58-year old, male patient.   The patient's concurrent condition included ulcerative colitis in remission. The patient's concomitant medications were not reported.   On 09-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The vial stopper felt loose when the syringe was inserted (explicitly coded as 'Product use issue') and part of the product did not reach the muscle (explicitly coded as 'Incomplete dose administered'). The healthcare professional did not stop giving the vaccine when encountered pressure. Part of the product was running down patient's skin in the arm (explicitly coded as 'Accidental exposure to product'). The device associated with Afluria Quadrivalent was Luer Lok syringe. The batch number reported was P100247218.   On the same day, after receiving Afluria QIV, the patient experienced tenderness. There was no side effect on the skin.  At the time of follow up reporting on 15-Sep-2020, the outcome of the event tenderness was not reported.  Quality Assurance (QA) investigation of Afluria Quadrivalent, batch number P100247218 (PTC number: 1066578) found that after review of the final investigation, there was no internal root cause identified and the manufacturing process was not at fault for the filed complaint. The facility, methods and controls used for the processing of this batch were in conformance with master batch record requirements. A review of the executed batch records indicated the batch was manufactured according procedures. From the review of the details for this complaint multiple potential faults were identified where user handling was the most likely cause for this PTC, therefore this was the most likely cause of this complaint. It is concluded that 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 syringe/luer lock connection was 1 Defects/Million Syringes distributed. No additional actions were required for Afluria Quadrivalent for batch P100247218.  The reporter assessed the event tenderness to be related (reported as tenderness from injection) to Afluria Quadrivalent.  The reporter assessed the case as non-serious.  This case has been entered onto Seqirus's manufacturing quality assurance tracking database and allocated reference number 1066578.  Additional information received on 16-Sep-2020 from a pharmacist and processed together with an additional information received on 22-Sep-2020: New reporter added. The case and events updated to medically confirmed. More information on 'product use issue' provided. Product Technical Complaint (PTC) number and additional reference number added. Event of 'Exposure via skin contact' removed. Narrative amended accordingly.  Case updated on 10-Oct-2020: Correction made to information received 16-Sep-2020: Vaccine indication was recoded. Also, additional information received on 31-Oct-2020 from Product Technical Complaint (PTC): QA investigation provided. Narrative was amended accordingly.  Company comment: The patient was vaccinated with the suspect product, Afluria Quadrivalent. Reportedly, the vial stopper felt loose when the syringe was inserted (explicitly coded as 'Product use issue') and part of the product did not reach the muscle (explicitly coded as 'Incomplete dose administered'). The healthcare professional did not stop giving the vaccine when encountered pressure. Part of the product was running down patient's skin in the arm (explicitly coded as 'Accidental exposure to product'). On the same day, after receiving Afluria QIV, the patient experienced tenderness. Chronology is suggestive. There was no side effect on the skin. Based on provided information, causal relationship between the suspect product Afluria Quadrivalent and the event of tenderness is assessed as possibly related (defaults to 'related' in the safety database for reporting purposes) and not related to Luer Lok syringe. Causality for all other mentioned events is assessed as not related to Afluria Quadrivalent per company's conventions. Causality for the event of 'product use issue' is assessed as related to device Luer Lok syringe, while all other events are assessed as not related.; Reporter's Comments: There was no side effect on the skin, only tenderness from injection.; Sender's Comments: The patient was vaccinated with the suspect product, Afluria Quadrivalent. Reportedly, the vial stopper felt loose when the syringe was inserted (explicitly coded as 'Product use issue') and part of the product did not reach the muscle (explicitly coded as 'Incomplete dose administered'). The healthcare professional did not stop giving the vaccine when encountered pressure. Part of the product was running down patient's skin in the arm (explicitly coded as 'Accidental exposure to product'). On the same day, after receiving Afluria QIV, the patient experienced tenderness. Chronology is suggestive. There was no side effect on the skin. Based on provided information, causal relationship between the suspect product Afluria Quadrivalent and the event of tenderness is assessed as possibly related (defaults to 'related' in the safety database for reporting purposes) and not related to Luer Lok syringe. Causality for all other mentioned events is assessed as not related to Afluria Quadrivalent per company's conventions. Causality for the event of 'product use issue' is assessed as related to device Luer Lok syringe, while all other events are assessed as not related.