Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Minimal bleeding (a small speck of blood at site of administration); As I began to administer the shot, this flared grip broke off / detached from the syringe; Most, if not all of the vaccine remained in the syringe body; This spontaneous case was retrieved on 26-Oct-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 879551-1), reported by other health professional and concerned a 60-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 14-Aug-2020, during administration of Afluria Quadrivalent (influenza vaccine; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported) the flared grip broke off and detached from the prefilled syringe (explicitly coded as 'Syringe issue'). The vaccine administration was ceased immediately, and the syringe, with needle attached, was removed from the patient's arm. The batch number reported was P100229089.  On the same day, after removing syringe from the patient's arm, minimal bleeding, as small speck of blood at site of administration, was noted. It was reported that the most, if not all of the vaccine remained in the syringe body (explicitly coded as: 'Incomplete dose administered') and the reporter re-administered without incident the same vaccine with same lot shortly after. The vaccine was administered to the left deltoid, one inch from original site, since the patient insisted on left arm again. The reporter notified her primary care provider of the incident.  The outcome of the event was unknown.  The reporter did not provide causality assessment to Afluria Quadrivalent vaccine.  The case was assessed as non-serious.  This case has been entered onto Seqirus's manufacturing quality assurance tracking database and allocated reference number 1071600.  Quality assurance investigation (QAI) determined that root cause could not be confirmed through a review of the manufacturing processes and shipping review. The most probable root cause of broken finger flange on one syringe in Afluria batch P100229089 2020/2021 campaign was due to packaging equipment in CSL fill/finish facility. Shipping of the product was also possible root cause for the events, as it could not be completely ruled out. Since the packaging line was the most likely root cause, the root cause had been assigned as 'Equipment Malfunction' and the complaint was justified.   Additional information received on 17-Dec-2020 from Seqirus' manufacturing quality assurance department: Added the tracking database reference number assigned to the case.  QAI result was provided. The narrative was amended accordingly.   Company comment: The patient developed vaccination site haemorrhage on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, during administration of Afluria Quadrivalent the flared grip broke off and detached from the prefilled syringe (explicitly coded as 'Syringe issue'). It was reported that the most, if not all of the vaccine remained in the syringe body (explicitly coded as: 'Incomplete dose administered') and the reporter re-administered without incident the same vaccine with same lot shortly after. Causal relationship for the event of vaccination site haemorrhage is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Incomplete dose administered and syringe issue are not related per company's conventions.; Sender's Comments: The patient developed vaccination site haemorrhage on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. Reportedly, during administration of Afluria Quadrivalent the flared grip broke off and detached from the prefilled syringe (explicitly coded as 'Syringe issue'). It was reported that the most, if not all of the vaccine remained in the syringe body (explicitly coded as: 'Incomplete dose administered') and the reporter re-administered without incident the same vaccine with same lot shortly after. Causal relationship for the event of vaccination site haemorrhage is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Incomplete dose administered and syringe issue are not related per company's conventions.