Age: 76.0
Sex: M
Vaccine: FLUC4, FLUA4
Symptoms: Swelling face, Tongue disorder, Vaccine positive rechallenge
Clinical narrative: Facial swelling; Tongue thickening; This spontaneous case was retrieved on 21-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 896956-1), reported by other health professional and concerned a 76-year-old, male patient.   The patient's concurrent conditions included diabetes, pulmonary fibrosis, benign prostatic hyperplasia (BPH), hypertension (HTN), coronary artery disease (CAD), thrombocytopenia and allergy to lisinopril and venlafaxine. The patient's concomitant medications included Invokana (canagliflozin), Lantus (insulin glargine), ivermectin, Cozaar (losartan potassium), prednisone, Crestor (rosuvastatin calcium), Flomax (tamsulosin hydrochloride) and Zyrtec (cetirizine hydrochloride), all used for unreported indications. The patient's historical vaccine included an influenza vaccine received on 11-Oct-2018 after which the patient experienced facial swelling and tongue thickening.   On 12-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location and indication: not reported). The batch number reported was 279820.  On 16-Nov-2020, four days after receiving Fluad Quadrivalent, the patient experienced facial swelling and tongue thickening. The patient was admitted to emergency room overnight as observation. The patient felt it was allergy to lisinopril (as reported). The patient received Benadryl (diphenhydramine hydrochloride), Solumedrol (methylprednisolone sodium succinate), Claritin (clarithromycin) and Pepcid (aluminium hydroxide gel, dried, magnesium carbonate) in ER and latter then discharged home.   On an unspecified date in Nov-2020, the patient recovered from events.   The reporter did not provide a causality assessment.  The event of facial swelling and tongue thickening were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The case is linked to the case 202007991 due to the same patient.  Company comment: A 76-year-old male patient experienced swelling face and tongue disorder 4 days after administration of Fluad Quadrivalent. The patient's concurrent conditions included diabetes, pulmonary fibrosis, benign prostatic hyperplasia, hypertension, coronary artery disease, thrombocytopenia and allergy to lisinopril and venlafaxine. The patient's concomitant medications included Invokana (canagliflozin), Lantus (insulin glargine), ivermectin, Cozaar (losartan potassium), prednisone, Crestor (rosuvastatin calcium), Flomax (tamsulosin hydrochloride) and Zyrtec (cetirizine hydrochloride), all used for unreported indications. The patient's historical vaccine included an influenza vaccine received on 11-Oct-2018 after which the patient experienced facial swelling and tongue thickening. Causality is assessed as possibly related for both events but possibly confounded with reported concomitant drugs, especially lisinopril.; Sender's Comments: A 76-year-old male patient experienced swelling face and tongue disorder 4 days after administration of Fluad Quadrivalent. The patient's concurrent conditions included diabetes, pulmonary fibrosis, benign prostatic hyperplasia, hypertension, coronary artery disease, thrombocytopenia and allergy to lisinopril and venlafaxine. The patient's concomitant medications included Invokana (canagliflozin), Lantus (insulin glargine), ivermectin, Cozaar (losartan potassium), prednisone, Crestor (rosuvastatin calcium), Flomax (tamsulosin hydrochloride) and Zyrtec (cetirizine hydrochloride), all used for unreported indications. The patient's historical vaccine included an influenza vaccine received on 11-Oct-2018 after which the patient experienced facial swelling and tongue thickening. Causality is assessed as possibly related for both events but possibly confounded with reported concomitant drugs, especially lisinopril.