Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Full blood count, Full blood count abnormal, Hypertransaminasaemia
Clinical narrative: ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; BLOOD LACTIC ACID INCREASED; PNEUMONIA VIRAL; PRODUCTIVE COUGH; LACTIC ACIDOSIS; LEUKOCYTOSIS; PULMONARY EMBOLISM; SCAN WITH CONTRAST ABNORMAL; BLOOD CREATININE INCREASED; LACTIC ACIDOSIS; BLOOD LACTIC ACID INCREASED; PULMONARY EMBOLISM; DYSPNOEA EXERTIONAL; ECHOCARDIOGRAM NORMAL; EJECTION FRACTION NORMAL; FIBRIN D DIMER INCREASED; FULL BLOOD COUNT ABNORMAL; HYPERTRANSAMINASAEMIA; INFLAMMATORY MARKER INCREASED; INTENSIVE CARE; LEUKOCYTOSIS; LUNG INFILTRATION; LUNG INFILTRATION; MECHANICAL VENTILATION; MECHANICAL VENTILATION; PERIPHERAL ARTERY ANEURYSM; PERIPHERAL ARTERY ANEURYSM; POSITIVE AIRWAY PRESSURE THERAPY; POSITIVE AIRWAY PRESSURE THERAPY; PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED; CARDIAC DISORDER; COVID-19; CHEST DISCOMFORT; CARDIAC DISORDER; DECREASED APPETITE; SCAN WITH CONTRAST ABNORMAL; TACHYCARDIA; SHIFT TO THE LEFT; TROPONIN NORMAL; SPUTUM DISCOLOURED; ULTRASOUND DOPPLER ABNORMAL; TACHYCARDIA; WHEEZING; TROPONIN NORMAL; ANGIOGRAM PULMONARY ABNORMAL; ULTRASOUND DOPPLER ABNORMAL; ANTICOAGULANT THERAPY; PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED; SARS-COV-2 TEST POSITIVE; ANGIOGRAM PULMONARY ABNORMAL; COVID-19 PNEUMONIA; ANTICOAGULANT THERAPY; PNEUMONIA VIRAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; CHEST DISCOMFORT; PYREXIA; SHIFT TO THE LEFT; SARS-COV-2 TEST POSITIVE; SPUTUM DISCOLOURED; WHEEZING; COMPUTERISED TOMOGRAM THORAX ABNORMAL; DYSPNOEA; PRODUCTIVE COUGH; PYREXIA; COVID-19; BLOOD CREATININE INCREASED; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2347525) concerned a 74 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection (2 Years ago), and concurrent conditions included: psoriasis, hypertension, dyslipidemia, tobacco abuse, alcohol use (was drinking up to half a pint of vodka at twice a week, His last drink was 12 days ago), poor appetite, High density lipoprotein, and other pre-existing medical conditions included: No history of alcohol withdrawal. Patient denied any sick contact in the recent past. The patient experienced heartburn when treated with ciprofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 17-AUG-2021 for an unspecified indication. Age at time of vaccination 74 years old. Concomitant medications included secukinumab for hypertension, amlodipine, atorvastatin, clobetasol, diazepam, escitalopram, salbutamol, tadalafil, and torasemide.  On 03-FEB-2022, The patient presented to the hospital with shortness of breath (dyspnea), fever (pyrexia) and cough (productive cough). He was hypoxic and require initially BiPAP had bilateral wheezing his COVID-19 test was positive (covid-19) and (sars-cov-2 test positive). The patient was transferred from emergency department for management of acute hypoxic respiratory failure secondary to COVID-19 pneumonia and bilateral pulmonary embolism with signs of right heart strain. He presented emergency room with a complaint of shortness of breath. Patient was in relatively good state of health until 4 days ago when he started to had progressively worsening dyspnea worse with exertion. He also reported cough productive of yellowish sputum since 2 days ago. He reported right-sided chest heaviness. No palpitations, fever, chills or rigors. Patient denied any sick contact in the recent past. No report of nausea vomiting or diarrhea. Patient denied use of tobacco products. On 13-FEB-2022 Upon evaluation at the emergency room he was afebrile. He was hypoxic with oxygen saturation 86 percent on room air. He was tachycardic significant lab findings were creatinine of 1.31 which was close to his baseline and mild transaminitis. He was also noted to had lactic acidosis at 6.1 and proBNP of 1279, Lactic acid trended down to 2.6 after intravenous hydration. Complete blood count revealed leukocytosis at 19,000 with slight left shift D-dimer was significantly elevated more than 35 computed tomography, chest with intravenous contrast was obtained which revealed right-sided pulmonary thromboembolism involving right middle lower and lower lobes with some signs of right heart strain, However troponin was negative, computed tomography chills also revealed patchy multifocal bilateral infiltrates suggestive of viral pneumonitis. Nasopharyngeal swab was positive for COVID-19. At the referring facility emergency department patient was started with intravenous heparin drip. He also received intravenous Solu-Medrol DuoNeb nebulization and ceftriaxone intravenous. The patient had elevated inflammatory markers and elevated D-dimer, computerized tomography chest angiogram show bilateral multiple pulmonary embolism. Initially worrisome for submissive pulmonary embolism with right ventricular strain the patient placed on heparin drip and the cardiologist consulted and the patient had echocardiogram show EF (ejection fraction) 60% without signs of right ventricular strain. The cardiologist recommend on anticoagulation and no intervention the patient admitted to the intensive care unit and he require to be on noninvasive ventilator BiPAP and OptiFlow. He received decadron and remdesivir and antibiotics for possible secondary bacterial pneumonia. He was not candidate for Actemra because he was on immunosuppressive therapy for history assess. The patient had history of alcoholism but he did not develop any signs of alcohol withdrawal, history of hypertension dyslipidemia and were controlled. The patient did had lower limbs Doppler ultrasound show asymptomatic, popliteal aneurysm and no deep vein thrombosis. The patient off oxygen gradually and oxygen walking test done before the patient discharged and show the patient did not require oxygenation at rest and required 2 Liter of oxygen with activities discussed with the patient would discharge the patient home with home oxygen and continue tapered steroids. The patient hospitalized for 14 days The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory failure, angiogram pulmonary abnormal, anticoagulant therapy, blood creatinine increased, blood lactic acid increased, covid-19, covid-19 pneumonia, cardiac disorder, chest discomfort, computerised tomogram thorax abnormal, decreased appetite, dyspnoea, dyspnoea exertional, echocardiogram normal, ejection fraction normal, fibrin d dimer increased, full blood count abnormal, hypertransaminasaemia, inflammatory marker increased, intensive care, lactic acidosis, leukocytosis, lung infiltration, mechanical ventilation, peripheral artery aneurysm, pneumonia viral, positive airway pressure therapy, productive cough, prohormone brain natriuretic peptide increased, pulmonary embolism, pyrexia, sars-cov-2 test positive, scan with contrast abnormal, shift to the left, sputum discoloured, tachycardia, troponin normal, ultrasound doppler abnormal, and wheezing. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000243179. 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 central complaint vigilance department on 25-AUG-2022. 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 about Product quality complaint investigation result. This does not alter previous causality assessment of the reported events.   20220732778-covid-19 vaccine ad26.cov2.s- pulmonary embolism, angiogram pulmonary abnormal, anticoagulant therapy, computerised tomogram thorax abnormal. This event(s) is labeled per RSI and is therefore considered potentially related.  20220732778-covid-19 vaccine ad26.cov2.s-acute respiratory failure, blood creatinine increased, blood lactic acid increased, covid-19, covid-19 pneumonia, cardiac disorder, chest discomfort, decreased appetite, dyspnoea, dyspnoea exertional, echocardiogram normal, ejection fraction normal, fibrin d dimer increased, full blood count abnormal, hypertransaminasaemia, inflammatory marker increased, intensive care, lactic acidosis, leukocytosis, lung infiltration, mechanical ventilation, peripheral artery aneurysm, pneumonia viral, positive airway pressure therapy, productive cough, prohormone brain natriuretic peptide increased, pyrexia, sars-cov-2 test positive, scan with contrast abnormal, shift to the left, sputum discoloured, tachycardia, troponin normal, ultrasound doppler abnormal, and wheezing.. The event(s) 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(s). Therefore, this event(s) is considered unassessable.