Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sleep study, Sputum discoloured, Viral infection
Clinical narrative: LEFT VENTRICULAR FAILURE; DIALYSIS; RESPIRATORY FAILURE; PULMONARY FUNCTION TEST ABNORMAL; CARDIAC FAILURE ACUTE; CARDIAC FAILURE CONGESTIVE; CARDIAC FAILURE CONGESTIVE; CHRONIC RESPIRATORY FAILURE; MALNUTRITION; PERCUTANEOUS CORONARY INTERVENTION; CONDITION AGGRAVATED; CORONARY ARTERY DISEASE; DIALYSIS; PRODUCTIVE COUGH; INCENTIVE SPIROMETRY; DYSPNOEA; CHEST X-RAY NORMAL; RESPIRATORY FAILURE; GLYCOSYLATED HAEMOGLOBIN INCREASED; SPUTUM DISCOLOURED; PULMONARY FUNCTION TEST ABNORMAL; ECHOCARDIOGRAM ABNORMAL; SARS-COV-2 TEST POSITIVE; ASTHENIA; ASTHENIA; PULMONARY HYPERTENSION; FATIGUE; CONDITION AGGRAVATED; PYREXIA; GLYCOSYLATED HAEMOGLOBIN INCREASED; SPUTUM DISCOLOURED; FATIGUE; DYSPNOEA; OROPHARYNGEAL PAIN; OROPHARYNGEAL PAIN; INCENTIVE SPIROMETRY; RHINORRHOEA; SARS-COV-2 TEST POSITIVE; COVID-19; CARDIAC FAILURE ACUTE; CHRONIC RESPIRATORY FAILURE; VIRAL INFECTION; PRODUCTIVE COUGH; CHEST X-RAY NORMAL; VIRAL INFECTION; PYREXIA; CORONARY ARTERY DISEASE; DIASTOLIC DYSFUNCTION; PERCUTANEOUS CORONARY INTERVENTION; POSITIVE AIRWAY PRESSURE THERAPY; CATHETERISATION CARDIAC ABNORMAL; LEFT VENTRICULAR FAILURE; ECHOCARDIOGRAM ABNORMAL; RHINORRHOEA; EJECTION FRACTION NORMAL; COVID-19; DIASTOLIC DYSFUNCTION; MALNUTRITION; PULMONARY HYPERTENSION; EJECTION FRACTION NORMAL; POSITIVE AIRWAY PRESSURE THERAPY; CATHETERISATION CARDIAC ABNORMAL; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System, VAERS ID 2550222) concerned a 59 year old female of an unspecified race and ethnicity. Initial information was processed with the additional information received on 16-JAN-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, hyperlipidemia, insulin-dependent diabetes mellitus, coronary artery disease, chronic diastolic CHF (Congestive heart failure), chronic hypoxemic respiratory failure (on 3L (Liters) of oxygen through nasal cannula), end-stage renal disease (on regular hemodialysis sessions), diabetic neuropathy, anemia, and metabolic acidosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 02-APR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 59 years old. Concomitant medications included carvedilol, clonidine, hydralazine, isosorbide mononitrate and nifedipine for hypertension, insulin glargine (Lantus) for insulin-dependent diabetes mellitus, atorvastatin, and gabapentin. On 07-OCT-2022, the patient's echocardiogram was abnormal which showed normal EF (ejection fraction) 70 percent, grade 2 diastolic dysfunction, pulmonary hypertension RVSP (right ventricular systolic pressure) 48 mmHg reduced average global longitudinal strain of 12.9 percent and pattern suggestive of cardiac amyloid. On an unspecified date in NOV-2022, the patient had left heart catheterization (catheterisation cardiac) where results found to be abnormal which showed severe two-vessel coronary artery disease with successful percutaneous coronary intervention, RCA (right coronary artery) ISR (in-stent restenosis) with POBA (plain old balloon angioplasty). On 14-DEC-2022, the patient experienced viral syndrome (viral infection), 4 days duration covid-19 virus infection (covid-19), chronic hypoxemic respiratory failure (chronic respiratory failure) was presumed COPD (chronic obstructive pulmonary disease) and obstructive sleep apnea, symptoms included: fever (pyrexia), chills, rhinorrhoea, sore throat (oropharyngeal pain), productive cough of yellow sputum (sputum discoloured), shortness of breath (dyspnoea), generalized weakness (asthenia), fatigue and was hospitalized (date unspecified). On admission, patient was given oxygen requirements 3 Liters of oxygen through nasal cannula. On 18-DEC-2022 (latency reported as 625 days), the patient tested positive for sars-cov-2 test and underwent for vaccinated imaging chest x-ray found normal/no infiltrate and the patient also experienced cardiac failure acute, cardiac failure congestive, left ventricular failure, respiratory failure, malnutrition, condition aggravated, dialysis, incentive spirometry, glycosylated haemoglobin increased, pulmonary function test abnormal. Laboratory data included: Chest X-ray normal, Glycosylated haemoglobin increased, Pulmonary function test abnormal, and SARS-CoV-2 test Positive. Laboratory data (dates unspecified) included: HbA1C 6.2. The patient received treatment medications (dates unspecified) included: steroids, ceftriaxone sodium (rocephin), azithromycin (zithromax), remdesivir, oxygen, and dexamethasone, and antibiotics were discontinued per infectious disease consultants following infectious disease consult anticipated special isolation end date on 28-DEC-2022. The patient was suggested to continue spirometry and bronchodilators (unspecified medication). The patient had finished 5 days of remdesivir and 10 days dexamethasone. At the time of this report the patient on baseline of 3 L(liter) nasal cannula during day and continuous positive airway pressure (CPAP) (positive airway pressure therapy) at night time and reported lung exam improved (date unspecified), and was okay to be discharged. Patient was advised to take discharge regimen with Imdur 30 mg daily, Coreg 25 mg twice daily, hydralazine 100 g 3 times daily and Clonidine patch weekly. Initially nifedipine 60 mg twice daily was stopped on admission, resumed at low-dose 30 mg daily. It was reported that the patient blood pressure was stable over 24 to 48 hours before discharge. The patient was advised to continue home dose Lantus 10 units nightly and insulin sliding scale, gabapentin twice daily, on regular hemodialysis sessions for end-stage renal disease, atorvastatin 80 mg daily for hyperlipidemia, moderate protein calorie malnutrition nutrition consult and nephrology consulted to resume HD (hemodialysis) and UF (ultrafiltration). The patient was hospitalized for 11 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthenia, covid-19, cardiac failure acute, cardiac failure congestive, catheterisation cardiac abnormal, chest x-ray normal, chronic respiratory failure, condition aggravated, coronary artery disease, dialysis, diastolic dysfunction, dyspnoea, echocardiogram abnormal, ejection fraction normal, fatigue, glycosylated haemoglobin increased, incentive spirometry, left ventricular failure, malnutrition, oropharyngeal pain, percutaneous coronary intervention, positive airway pressure therapy, productive cough, pulmonary function test abnormal, pulmonary hypertension, pyrexia, respiratory failure, rhinorrhoea, sars-cov-2 test positive, sputum discoloured and viral infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000267136. 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 received from Complaint Vigilance department on 24-JAN-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The additional information in this version is  Product quality complaint investigation result. This doesnot alter causality of previously reported events. 20230129574- Pulmonary hypertension, Cardiac failure acute, Cardiac failure congestive, Chronic respiratory failure, Left ventricular failure, Respiratory failure, Coronary artery disease, Diastolic dysfunction, Malnutrition, Dialysis, Percutaneous coronary intervention, Incentive spirometry, Positive airway pressure therapy, Catheterisation cardiac abnormal, Echocardiogram abnormal, Glycosylated haemoglobin increased, Pulmonary function test abnormal. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.  20230129574- Condition aggravated, Chest x-ray normal, Ejection fraction 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.  20230129574-Viral infection, Productive cough, Oropharyngeal pain, Rhinorrhoea, Covid-19, Sputum discoloured, Dyspnoea, Sars-cov-2 test positive, Asthenia, Fatigue, Pyrexia. 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.