Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Injection site discharge, Syringe issue, Underdose, Vaccination site extravasation
Clinical narrative: Some liquid leaked out of the patient's arm; Not all the medication was released into the patient's arm; Not all the medication was released into the patient's arm/HCP is specifically talking about the PFS; This spontaneous case was received on 01-Dec-2022 from the other healthcare professional via Communications (reference number SEQW22-06178) with additional information received on 06-Dec-2022 from the Seqirus PTC reporting, and 19-Dec-2022 (being processed together) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  It was reported that on 01-Dec-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose:0,5ml, anatomical location: arm, route of administration: not reported) for active immunization against disease caused by influenza virus subtypes A and B present in the vaccine. The batch number reported was 348386 (the reported batch number was identified by Seqirus to be most likely batch: 346386) with an expiry date 30-Jun-2022. The reported batch number was identified by Seqirus to be linked to the suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent. The device associated with Fluad Quadrivalent was a luer lok syringe. The nurse gave a shot to a patient, and not all the medication was released into the patient's arm (explicitly coded as 'Incomplete dose administered'). After being administered, some liquid leaked out of the patient's arm. However, the nurse reported no related defect, damage, or leakage associated with the vaccine (explicitly coded as 'syringe issue').   At the time of initial reporting, on 01-Dec-2022, there were no complaints or negative reports from the patient after the Fluad Quadrivalent administration.   The reporter assessed the events of 'incomplete dose administered,' vaccination site extravasation,' and 'syringe issue' as unrelated to the Fluad Quadrivalent and related to the Luer lok syringe. As reported, HCP specifically talked about the prefilled syringe (PFS) and discarded any problem related to the vaccine itself.  The case was assessed as non-serious.  Case updated on 20-Dec-2022: Correction made to information received on 01-Dec-2021: The case classification "Special case with no AE' was removed. The event of 'Vaccination site extravasation' was added. The narrative was amended accordingly.  Company comment: A female patient of unknown age was vaccinated with Fluad Quadrivalent. Reportedly, during the vaccine administration, not all the medication was released into the patient's arm, and after being administered, some liquid leaked out of the patient's arm (explicitly coded as 'Incomplete dose administered' and 'Syringe issue'). The patient additionally experienced vaccination site extravasation following vaccination. Based on provided information incomplete dose administered, vaccination site extravasation and syringe issue are assessed as not related to the suspect vaccine but to the Luer lok syringe.; Reporter's Comments: HCP is specifically talking about the prefilled syringe (PFS) and discards any problem related to the vaccine itself.; Sender's Comments: A female patient of unknown age was vaccinated with Fluad Quadrivalent. Reportedly, during the vaccine administration, not all the medication was released into the patient's arm, and after being administered, some liquid leaked out of the patient's arm (explicitly coded as 'Incomplete dose administered' and 'Syringe issue'). The patient additionally experienced vaccination site extravasation following vaccination. Based on provided information incomplete dose administered, vaccination site extravasation and syringe issue are assessed as not related to the suspect vaccine but to the Luer lok syringe.