Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation, Injection site pain, Needle issue, Pain in extremity
Clinical narrative: Persistent pain [at injection site and] down arm; Upon 2nd injection, pt felt pain at injection site/persistent pain at injection site; During administration of flu shot, device malfunctioned/ syringe issue; Drug administration error; This is a spontaneous case reported by other health professional to VAERS (VAERS ID: 787401) and initially retrieved on 27-Feb-2019 and follow up received on 01-Mar-2018 (both initial and follow up versions being processed together), concerning a 47-year-old, adult female patient.  The patient had no known drug allergies.  It was reported that on 18-Oct-2018, during the administration of the vaccine, the device malfunctioned (explicitly coded as syringe issue) and the pharmacist had to get another tip and reinject the patient.  On the same day, the patient was administered the second injection of Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: YF37806A and expiry date: not reported] (explicitly coded as drug administration error) for an unknown indication.   On the same day, upon the second injection, the patient experienced pain at the injection site. The patient had persistent pain at the injection site and down the arm since immunization. The pain had been relieved some with unspecified steroids but came back when steroids were discontinued. It was reported that the patient had 2 physician (MD) visits on unspecified dates.  The outcome of the events injection site pain and pain in arm was not recovered.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was PR648326.  The reporter assessed the case as non-serious.  Follow-up received from the reporter on 05-Mar-2019: It was reported that based on the initial assessment, the device malfunctioned during administration and the health care professional changed the needle before re-injecting the patient. The device malfunction alludes to a needle related issue rather than a syringe issue, as the needle was changed and the vaccine re-administered. Seqirus does not provide a needle with this vaccination, as Afluria Quadrivalent is a syringe free presentation. Hence, no further action was taken.  Case re-opened for completion of full data entry: 05-Mar-2019.; Reporter's Comments: A 47-year-old, female patient experienced injection site pain and pain in arm, on the same day after second vaccination with Afluria Quadrivalent (drug administration error). It was reported that during the administration, the device malfunctioned (syringe issue). The company assessed the causality of the events injection site pain and pain in arm as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine. The company assessed the causality of the events syringe issue and drug administration error as not related to the suspect vaccine considering the event syringe issue as incidental nature of the event and drug administration error as accidental nature of the event.