Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Sinus bradycardia, Tricuspid valve incompetence, Wall motion score index
Clinical narrative: CHRONIC RESPIRATORY FAILURE; TRICUSPID VALVE INCOMPETENCE; HYPOTHYROIDISM; HYPOKALAEMIA; LEFT ATRIAL ENLARGEMENT; CORONARY ARTERY DISEASE; SINUS BRADYCARDIA; CHEST PAIN; COUGH; MALAISE; PERCUTANEOUS CORONARY INTERVENTION; ANTICOAGULANT THERAPY; BLOOD POTASSIUM DECREASED; CARDIAC INDEX INCREASED; SARS-COV-2 TEST POSITIVE; CATHETERISATION CARDIAC ABNORMAL; ECHOCARDIOGRAM ABNORMAL; CHEST X-RAY NORMAL; COMPUTERISED TOMOGRAM THORAX NORMAL; EJECTION FRACTION NORMAL; WALL MOTION SCORE INDEX NORMAL; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 2572173) concerned a 43 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: obstructive sleep apnea, CAD (Coronary artery disease), and HTN (Hypertension). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported administered for an unspecified indication. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total administered on 28-OCT-2021 for an unspecified indication. Age at time of vaccination 43 years old. No concomitant medications were reported.  On 02-FEB-2022, the patient had recent cardiac catheterisation, result not reported. On 30-DEC-2022 (latency of 428 days), the patient started to experience the symptoms of covid-19 (Dose number in series 2). On 31-DEC-2022 (latency reported as 429 days), the patient experienced cough, malaise and on same day was tested positive for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) (Dose number in series 2). On an unspecified date patient was hospitalized and on admission patient had cough. Chest X-ray was negative (Chest X-ray normal) and oxygen requirements on admission was room air and was started on Decadron (dexamethasone). The patient had following cardiology consultation and anticipated special isolation for 10 days from test (Dose number in series 2). On 31-DEC-2022, the patient experienced chronic respiratory failure 4 liter at night, hypothyroidism which was subclinical, repeated after COVID-19 and was symptomatic and the patient was started on low dose Synthroid (levothyroxine sodium), hypokalaemia where potassium level was 3.3 (blood potassium decreased) and 40 mEq of potassium was provided, Sinus bradycardia at night and was likely related to underlying obstructive sleep apnea and was advised to avoid calcium channel blocker and beta-blocker and was using outpatient Holter monitor (Dose number in series 2). On 31-DEC-2022, the patient's heart catheterisation was severe (catheterisation cardiac abnormal) 1 vessel CAD of the LAD (left anterior descending artery) with nonobstructive RCA (Right coronary artery) disease (coronary artery disease) and had successful percutaneous coronary intervention of the LAD and had to be on aspirin (anticoagulant therapy) (acetylsalicylic acid) 81 mg indefinitely and Plavix (clopidogrel bisulfate) for 1 year. On 31-DEC-2022, the patient experienced chest pain and echocardiogram was performed which was abnormal (echocardiogram abnormal) where Ejection fraction 63% (ejection fraction normal), left atrium mildly enlarged (left atrial enlargement) other cardiac chambers were normal, left ventricular mass index is increased (cardiac index increased), left ventricular segmental wall motion is normal (wall motion score index normal), normal diastolic function, mild tricuspid valve regurgitation (tricuspid valve incompetence) and no pericardial effusion. CT pulmonary artery study was performed - negative for PE (pulmonary embolism) (computerised tomogram thorax normal) and was started on Imdur (isosorbide mononitrate) (Dose number in series 2). The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anticoagulant therapy, blood potassium decreased, covid-19, cardiac index increased, catheterisation cardiac abnormal, chest x-ray normal, chest pain, chronic respiratory failure, computerised tomogram thorax normal, coronary artery disease, cough, echocardiogram abnormal, ejection fraction normal, hypokalaemia, hypothyroidism, left atrial enlargement, malaise, percutaneous coronary intervention, sars-cov-2 test positive, sinus bradycardia, tricuspid valve incompetence and wall motion score index normal was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000271213. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from department on 17-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up adds information abut  Product quality complaint investigation result. This does not alter previous causality assessment of the reported events.  20230229047- Tricuspid Valve Incompetence, Hypothyroidism, Hypokalaemia, Left Atrial Enlargement, Coronary Artery Disease, Sinus Bradycardia,  Chest Pain,  Percutaneous Coronary Intervention, Anticoagulant Therapy, Blood Potassium Decreased, Cardiac Index Increased,  Catheterisation Cardiac Abnormal, Echocardiogram Abnormal. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  20230229047-Chronic Respiratory Failure, Covid-19, Cough, Malaise, Sars-Cov-2 Test Positive,. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  20230229047- Chest X-Ray Normal, Computerised Tomogram Thorax Normal, Ejection Fraction Normal, Wall Motion Score Index Normal. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.