Age: 70.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Angioedema, Complement factor C3, Complement factor C4, Swollen tongue
Clinical narrative: Right sided unilateral swelling of tongue - diagnosis of angioedema; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1713579-1), reported by other health professional and concerned a 70-year-old, male patient.  The patient's concurrent conditions included hypertension, hyperlipidaemia, gout flare and allergy to enalapril. The patient's historical drug included enalapril to which the patient experienced facial swelling. The patient's concomitant medications included potassium as supplement and losartan, allopurinol, nifedipine, baclofen and clonidine, all used for unreported indications.  On 15-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', indication, route of administration and anatomical location: not reported). The batch number reported was 312842.  On 17-Sep-2021, in the morning, two days after receiving Fluad Quadrivalent, the patient experienced right sided unilateral swelling of tongue. The patient was presented to the emergency department and admitted to the hospital for one day. The patient received intravenous (IV) steroids, Benadryl (diphenhydramine hydrochloride) and Pepcid (famotidine) as corrective treatment with improvement of symptoms. Complement factors C3 and C4 were within normal limits.  On 18-Sep-2021, the patient was discharged from the hospital with diagnosis of angioedema. The patient was prescribed with prednisone at a dose of 5 mg per oral (PO) for four days and the patient discontinued losartan, as well.   On an unknown day in Sep-2021, the patient recovered from the event.  The reporter assessed the event as related to Fluad Quadrivalent. The event of angioedema was secondary to flu vaccination on 15-Sep-2021 or long-standing losartan prescription.  The event of angioedema was considered as serious due to seriousness criteria of life-threatening condition and hospitalization. Additionally, the event of angioedema was considered to be medically significant by Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 70-year-old patient received Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced right sided unilateral swelling of tongue. The patient was discharged from the hospital with diagnosis of angioedema. The patient was prescribed with prednisone and discontinued treatment with losartan. The patient's concomitant medications also included allopurinol, nifedipine, baclofen and clonidine. Causality was highly confounded by concomitant medications, however causality cannot be totally excluded. Causal role of the suspect vaccine is assessed as unlikely related. (defaults to related in the safety database for reporting purposes).; Reporter's Comments: The event of angioedema was secondary to flu vaccination on 15-Sep-2021 or long-standing losartan prescription.; Sender's Comments: A 70-year-old patient received Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced right sided unilateral swelling of tongue. The patient was discharged from the hospital with diagnosis of angioedema. The patient was prescribed with prednisone and discontinued treatment with losartan. The patient's concomitant medications also included allopurinol, nifedipine, baclofen and clonidine. Causality was highly confounded by concomitant medications, however causality cannot be totally excluded. Causal role of the suspect vaccine is assessed as unlikely related. (defaults to related in the safety database for reporting purposes).