Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Anxiety, Exposure via skin contact, Occupational exposure to product, Syringe issue
Clinical narrative: Worried that some of the patient's blood might have gotten on her; The vaccine squirted out and it hit the HCP's arm; The vaccine squirted out and it hit the HCP's arm; This spontaneous case was received on 01-Sep-2020 from pharmacist via Agency (reference number: SEQW20-01140) and concerned a 28-year-old, female pharmacist.  The patient had no relevant medical history and was not taking any concomitant medications.  On 31-Aug-2020, while was administering to a patient Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived), the vaccine squirted out and hit the health care professional's (HCP) arm (explicitly coded as 'Occupational exposure while administering product' and 'Syringe leak''. The batch number reported was 279794 and expiration date 29-May-2021.  On the same day, the HCP was worried that some of the patient's blood might have gotten on her (due to the needle in the patient's arm) but said that she did not notice that it happened.  At the time of initial reporting on 01-Sep-2020, the outcome of the event 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 1065599.  An investigation into batch 279794 did not reveal anything that could account for events 'worry', 'occupational exposure while administering product' and 'syringe leak'. Quality Assurance investigation for this product complaint concluded that there was no manufacturing fault that led to the leaking luer lock during administration. The most likely cause for this complaint was improper handling of the syringe during the attachment of the needle to the luer lock. Historically the use of safety needles had led to an increase in number of leaking syringe complaints due to the complexity of the safety needle apparatus. During the attachment the complexity of the safety needle apparatus led to the user not attaching the needle tightly, thus caused a leak. In addition, there was no trend present for leaking luer locks as the current defect rate for Fluad Drug Product was two Defects/Million and there was also no trend within batch 279794.  This case is linked to case 202004284 (due to the same reporter).  Additional information was received on 16-Oct-2020 from Seqirus' manufacturing quality assurance department: Quality Assurance Investigation Results were provided. Narrative was amended accordingly  Company comment: Reportedly, while health care professional (HCP) was administering to a patient Fluad Quadrivalent vaccine, the vaccine squirted out and hit the HCP's arm (explicitly coded as 'Occupational exposure while administering product' and 'Syringe leak''. On the same day, the HCP developed anxiety since some of the patient's blood might have gotten on her (due to the needle in the patient's arm). Based on provided information, causal relationship between the suspect product and the event anxiety is assessed as not related. Causality for other two events was also assessed as not related per company conventions.; Sender's Comments: Reportedly, while health care professional (HCP) was administering to a patient Fluad Quadrivalent vaccine, the vaccine squirted out and hit the HCP's arm (explicitly coded as Occupational exposure while administering product' and Syringe leak'). On the same day, the HCP developed anxiety since some of the patient's blood might have gotten on her (due to the needle in the patient's arm). Based on provided information, causal relationship between the suspect product and the event anxiety is assessed as not related. Causality for other two events  was also assessed as not related per company conventions.