Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Incorrect dose administered, Vaccination site extravasation, Wrong technique in product usage process
Clinical narrative: Small amount of liquid pooled underneath bandage that may have been part of the dose leaked out of the injection site after administration; Dose was delivered through the bandage; Small amount of liquid pooled underneath bandage that may have been part of the dose leaked out of the injection site after administration; This spontaneous case was received on 17-Sep-2020 from pharmacist via Agency (reference number: SEQW20-01911) and concerned an 82-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On 15-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: less than 0.5 ml, route of administration: intramuscular and anatomical location: left deltoid) for protection against seasonal influenza. It was reported that the pharmacist had placed a 3M Injection Safe Barrier Bandage and dose was delivered through the bandage [explicitly coded as Wrong technique in product usage process']. The batch number reported was 279781, and expiry date: 12-May-2021.   On the same day, later that night, after receiving Fluad Quadrivalent, the patient removed the bandage and discovered a small amount of liquid pooled underneath the bandage. The pharmacist was concerned that the liquid may have been part of the dose and it might have somehow leaked out of the injection site after administration [explicitly coded as Incomplete dose administered']. No corrective treatment was given to the patient.   At the time of initial reporting on 17-Sep-2020, the outcome for the event of vaccination site extravasation' was not reported.   The reporter assessed the case as serious due to medically significance.  The reporter did not provide causality assessment.  Company comment: The patient developed vaccination site extravasation on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. Reportedly, the dose was delivered through the bandage and small amount of liquid pooled underneath bandage that may have been part of the dose leaked out of the injection site after administration [explicitly coded as Wrong technique in product usage process' and Incomplete dose administered']. Causal relationship for vaccination site extravasation is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Causality for other mentioned events is assessed as not related per company's conventions.; Sender's Comments: The patient developed vaccination site extravasation on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. Reportedly, the dose was delivered through the bandage and small amount of liquid pooled underneath bandage that may have been part of the dose leaked out of the injection site after administration [explicitly coded as Wrong technique in product usage process' and Incomplete dose administered']. Causal relationship for vaccination site extravasation is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Causality for other mentioned events is assessed as not related per company's conventions.