Sex: M
Vaccine: FLUA4
Symptoms: Coronary arterial stent insertion, Coronary artery stenosis, Dyspnoea, Echocardiogram, Echocardiogram abnormal
Clinical narrative: Coronary Artery stenosis; This clinical trial case, initially received on 10-Oct-2024,with additional follow up 11-Oct-2024 was reported by a health professional and concerns an elderly male subject. Weight: 79.2 kg; Height: 177 cm  The subject was enrolled in the study  Past medical history included Left Inguinal Hernia, Left Inguinal Hernia Repair. At the time of the event the subject had Hypercholesterolemia, Urinary Incontinence, Benign Prostatic Hyperplasia, Seasonal Allergies, Tobacco Abuse. Concomitant medication: refer to appropriate report section.   The subject's historical vaccine included influenza vaccine (brand not specified), received on 09-Dec-2022, for unreported indication.  Administration of company suspect drug: On 28-Nov-2023 11:44, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: No batch number available.  The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 16-Apr-2024, the subject experienced Coronary Artery stenosis (Hospitalized, outcome: Not recovered / Not resolved). Intensity was moderate.  Review of hospital medical records from 16-Apr-2024 to 17-Apr-2024. Per records, subject had seen by PCP prior to hospitalization with complaints of recent chest pain and palpitations and was therefore referred to cardiology for outpatient evaluation. Subject presented to cardiology office as scheduled on 15-Apr-2024 and had transthoracic echocardiogram which showed normal left ventricular systolic dysfunction with visually estimated EF of 60- 65%, no wall motion abnormality, and grade 1 diastolic filling pattern. Stress test that day was abnormal with inferolateral ischemia associated with chest pain and shortness of breath. 48-hour Holter monitor showed non-sustained VT, specifically with 1 episode of wide complex tachycardia lasting 5 beats with max rate of 200 bpm, no episode of sustained VT, and 1 SVT lasting 4 beats with max rate of 126 bpm with no episodes of sustained SVT. He was advised to go to the emergency room for further evaluation however subject stated he was unable to do so. Subject did present to the emergency room on 16-Apr-2024 when he woke at home with chest pain. He received 4 baby aspirin and sublingual nitroglycerin (see con-medication list) while in the ER which resolved his pain. Chest X-ray revealed no acute findings. Troponin x 2 were negative. EKG showed normal sinus rhythm with ventricular rate of 73 bpm with no acute ST or T wave abnormalities. Given his abnormal stress test completed the day prior, along with current presenting symptoms, he was sent from the ER for left heart catheterization on 16-Apr-2024 which showed 75% stenosis of the right posterolateral branch of the right coronary artery. This was successfully treated with reduction of the stenosis to 0% with IFR of the left anterior descending artery, balloon angioplasty, and 2.5 x 16mm Synergy stent placement in the right posterolateral branch of the right coronary artery. There was plaque shift noted at the distal end of the stent which was covered with a 2.25 x 12mm Synergy stent in overlapping fashion. Subject tolerated procedure well. He was discharged to home on 17-Apr-2024 with plan to follow-up with cardiology as an outpatient in 1-2 weeks. During hospitalization subject received the following medications: Isovue-370 100mL IV; Nicotine Patch 7mg QD transdermal; Nitroglycerin 0.4mg SL PRN; Lactated Ringers 1000mL with 1000U Heparin IV; Lidocaine 1% 30mL SC; Heparin 5000U SC; Verapamil 5mg PO; 0.9% NaCl (volume unspecified) IV; Nitroglycerin 100mcg SL; Versed 2mg IV and separately 1mg IV; Fentanyl 50mcg IV; Heparin 3000U IV; Plavix 600mg PO; lidocaine 1% 10mL SC; Aspirin 324mg PO. The subject verbalized they started feb-2024 and ended upon discharge from the hospital on 17-Apr-2024. The subject also verified the chest pain ended on 17-Apr-2024. The codeine intolerance started in 1994, and the subject confirmed they do not have a diagnosis of hypertension. They stated they are not on any medications for it, and it is only high for e brief time after arriving at any doctor appointment, but once the subject is able to sit and wait for 5-20 minutes, it goes down to a regular reading.  aQIVc HD vs QIVr vs aQIV action taken: Not Applicable  Treatment medication: Clopidogrel bisulfate 75 mg Every day/daily, Metoprolol succinate 25 mg Every day/daily, Naproxen sodium 220 mg As needed  Reporter's assessment: The investigator considered the event Coronary Artery stenosis as moderate and serious due to seriousness criteria of hospitalization and not related to the administration of the investigational drug. In the Investigator's opinion, the alternative cause for the event included was due to other (Coronary Artery stenosis).  The subject remained blinded in the study.  Follow-up (20-Nov-2024) received from an Investigator:  Added stop date of concomitant Metoprolol Succinate, Updated narrative accordingly.  Follow-up (22-Nov-2024) received investigator: additional concomitant medications aspirin, fentanyl, heparin, isovue, lactated ringers, lidocaine, nicotine patch, nitroglycerin, plavix, sodium chloride, verapamil, versed was added.  Follow-up (23-Nov-2024) received from an Investigator: Updated alternative cause for event Coronary Artery stenosis from other to other (Coronary Artery stenosis), Updated narrative accordingly.; Reporter's Comments: Causality: On 16-Apr-2024, four months 18 days after receiving the blinded study vaccine (aQIVc HD vs QIVr vs aQIV), the subject experienced Coronary Artery stenosis. The Sponsor agrees with investigator's assessment as not related as the subject's advanced age and underlying conditions, including hypercholesterolemia and tobacco use provide strong alternative explanations. Listedness was assessed using version.