Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Drug trough level, Dyspnoea, Exposure to SARS-CoV-2, Fibrin D dimer, Full blood count
Clinical narrative: ACUTE KIDNEY INJURY; PANCYTOPENIA; THROMBOCYTOPENIA; HYPERKALAEMIA; HYPOXIA; CARDIAC SARCOIDOSIS; PNEUMONIA; RESPIRATORY FAILURE; SEPSIS; ALANINE AMINOTRANSFERASE NORMAL; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY; ASPARTATE AMINOTRANSFERASE NORMAL; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BILIRUBIN NORMAL; BLOOD CHLORIDE INCREASED; BLOOD CREATININE INCREASED; BLOOD GLUCOSE NORMAL; BLOOD LACTIC ACID; BLOOD MAGNESIUM NORMAL; BLOOD POTASSIUM INCREASED; BLOOD SODIUM NORMAL; BLOOD UREA INCREASED; BRAIN NATRIURETIC PEPTIDE INCREASED; C-REACTIVE PROTEIN INCREASED; CARBON DIOXIDE DECREASED; CHEST X-RAY ABNORMAL; CONDITION AGGRAVATED; DRUG TROUGH LEVEL; FIBRIN D DIMER; FULL BLOOD COUNT ABNORMAL; HAEMOFILTRATION; HAEMOGLOBIN DECREASED; HEART TRANSPLANT; IMMUNOSUPPRESSANT DRUG THERAPY; INFECTION; INTERNATIONAL NORMALISED RATIO INCREASED; LIVER FUNCTION TEST NORMAL; LUNG ASSIST DEVICE THERAPY; LUNG OPACITY; MEAN CELL VOLUME NORMAL; NEUTROPHIL COUNT; PLATELET COUNT DECREASED; PLATELET-LARGE CELL RATIO; POSITRON EMISSION TOMOGRAM; PROTHROMBIN TIME PROLONGED; RIGHT VENTRICULAR DYSFUNCTION; SARS-COV-2 TEST POSITIVE; TACHYCARDIA; TROPONIN; URINARY SEDIMENT; URINE ANALYSIS; WHITE BLOOD CELL COUNT DECREASED; ASTHENIA; DYSPNEA; EXPOSURE TO SARS-COV-2; COVID-19; PYREXIA; CONFIRMED CLINICAL VACCINATION FAILURE; CHILLS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1963760) concerned a 60 year old male of an unknown race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension (HTN), hyperlipidemia, dysphasia, late effect of stroke, cardiomyopathy dilated, non-ischemic presence of biventricular implantable cardiac defibrillator (ICD), cerebrovascular disease, chronic kidney disease (CKD), glomerular filtration rate (GFR) 30-59, obstructive sleep apnea, atrial fibrillation paroxysmal, heart failure, reduced left ventricular ejection fraction (LVEF) 30%, unspecified acuity sarcoidosis presence of heart assist device anticoagulation monitoring, and anticoagulation, pulmonary sarcoidosis, gastroesophageal reflux disease, hypersensitivity lung disease (HLD) and atherosclerosis of aorta. In 2010, Laboratory data included: Alanine aminotransferase (ALT) 89, Alkaline phosphatase (ALP) 53 and 68, blood urea nitrogen (BUN) was 41 and 42, blood bilirubin 0.3, 0.4, blood sugar increased 144, 102, and 193, carbon dioxide (Co2) 16, 18, and 15, chloride (Cl) 112 and 106, creatinine 2.21, 2.28, and 2.89, potassium (K) was 5.2, 4.5, and 5.2, magnesium (MG) not reported, and sodium (Na) was 140,142, and 140.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for an unspecified indication. Concomitant medications included Decadron (dexamethasone) 6mg intravenous (IV) transitioned back to prednisone 10 milligram (mg) daily for covid-19, and pneumonia, Ecotrin (acetylsalicylic acid), Mycelefx troche (clotrimazole), Pepcid (famotidine) and Valcyte (valganciclovir hydrochloride) for drug used for unknown indication, Zarxia (filgrastim sndz), Hydralazine 25 milligram (mg) was continued three times a day (TID), Pantoprazole, Protonix (sodium sesquihydrate), doxycycline for heart transplantation, Prograf (tacrolimus) for immunosuppression, and infection, Cellcept 250 milligram (mg) (mycophenolate mofetil) for infection was continued twice a day and (BID), remdesivir for pancytopenia, covid-19, and pneumonia, patiromer for sarcoidosis.  On 10-SEP-2021 to 14-SEP-2021, he was admitted for acute kidney injury(AKI). After exposure on 24-NOV-2021 the patient had fevers, chills, and shortness of breath weakness. On 26-NOV-2021 he was covid positive concerned about rejected. On 26-NOV-2021, the patient had chills, dyspnea, pneumonia, pyrexia, respiratory failure, sepsis and was exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On same day, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test which showed positive result. He had covid-19 which resulted in confirmed clinical vaccination failure. The patient was isolated from 26-NOV-2021 to 17-DEC-2021. Then he took Decadron 6mg intravenous(IV) transitioned back to prednisone 10 milligram (mg) daily. Then, he took remdesevir therapy for pancytopenia which was probable covid related. On 05-NOV-2021 orthotropic heart transplant for cardiac sarcoidosis. Prograf, Mycophenolate-mofetil (mmf) and prednisone (pred) immunosuppression regimen maintained throughout therapy. Then, the patient took Cellcept 250 milligram (mg) and reduced given infection would need to readjusted later. Prograf was continued and followed daily levels trough 8-OCT-2021 to 6-DEC-2021 months and level was stable. Acute kidney injury(AKI) with hyperkalemia was continued. Patiromer medicine was continued to encourage per oral fluid (sic) sarcoidosis. prednisone was also taper. On 11-NOV-2021, repeated positron emission tomography (PET) and scanned 6 months post-transplant. Angiotensin-converting enzyme (AEC) levels (q 3) months next in January. On 01-DEC-2021, the patient also had acute kidney injury, thrombocytopenia, pancytopenia, hyperkalemia, hypoxia, cardiac sarcoidosis antineutrophil cytoplasmic antibody, alanine aminotransferase normal, aspartate aminotransferase normal, blood alkaline phosphatase normal, blood bilirubin normal, blood chloride increased, blood creatinine increased, blood glucose normal, blood lactic acid, blood magnesium normal, blood potassium increased, blood sodium normal, blood urea increased, brain natriuretic peptide increased, c-reactive protein increased, carbon dioxide decreased, chest x-ray abnormal, condition aggravated, drug trough level, fibrin d dimer, full blood count abnormal, hemofiltration, hemoglobin decreased, heart transplant immunosuppressant drug therapy, infection, international normalized ratio increased, liver function test normal, lung assist device therapy, lung opacity, mean cell volume normal, neutrophil count, platelet count decreased. platelet-large cell ratio, positron emission tomogram, prothrombin time prolonged, right ventricular dysfunction, tachycardia, troponin, urinary sediment, urine analysis, white blood cell count decreased, and asthenia. The patient had right ventricular (RV) dysfunctioning and required extracorporeal membrane oxygenation (ECMO) and continuous renal replacement therapy (CRRT). On 21-DEC-2021, the patient got therapy of transferred for further care. Patient had initially (LA)(sic) 63, febrile, tachycardia, hypoxemic but cleared with high-flow nasal cannula (HFNC) and intravenous fluid (IVFs) but due to de-escalated to regular nasal cannula (NC) another treatment started of decadron, remdesevir and continued on transplant medication with empiric coverage with cardiac transplantation. (CTX), Doxycycline (Doxy), He was hypoxic responsible failure of Covid positive (+ve), pneumonia (PNA), and sepsis. On 02-DEC-2021, acid base balance result was not reported. On 08-DEC-2021, last received zarxio 480 microgram(mcg) medicine. His WBC (white blood cells) was improved and Absolute Neutrophil Count (ANC) was stabled. Valcyte was continued and changed Pepcid to protonix. There was monitoring of aspirin (ASA) was hold and monitor platelets closely. Laboratory data included: Acid base balance result was not reported, alanine aminotransferase result was normal, Antineutrophil cytoplasmic antibody result was not reported, Aspartate aminotransferase result was normal, blood alkaline phosphatase result was normal, blood bilirubin result was normal, blood chloride result was increased, blood creatinine result was increased, blood glucose result was normal, and blood lactic acid result was not reported, His blood magnesium result was normal, blood potassium result was increased, Blood sodium result was normal, Blood urea result was increased, Brain natriuretic peptide result was increased, C-reactive protein result was increased to 6.7, Carbon dioxide result was decreased, Chest X-ray result was abnormal, drug trough level result was not reported, Fibrin D dimer result was more than 4.00, Full blood count result was abnormal, Hemoglobin result was decreased, International normalized ratio result was Increased, Liver function test result was normal, Mean cell volume result was normal, Neutrophil count result was not reported, Platelet count result was decreased, Platelet-large cell ratio result was not reported, Positron emission tomogram result was not reported, Prothrombin time prolonged result was not reported, Troponin result was 0.11, Urinary sediment result was not reported, Urine analysis result was not reported, and White blood cell count result was decreased. On an unspecified date, International normalized ratio (INR) test was performed result was 1.2. On an unspecified date, the patient was hospitalized, number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from acute kidney injury, thrombocytopenia, pancytopenia, hyperkalemia, hypoxia, cardiac sarcoidosis, alanine aminotransferase normal, antineutrophil cytoplasmic antibody, aspartate aminotransferase normal, blood alkaline phosphatase normal, blood bilirubin normal, blood chloride increased, blood creatinine increased, blood glucose normal, blood lactic acid, blood magnesium normal, blood potassium increased, blood sodium normal, blood urea increased, brain natriuretic peptide increased, c-reactive protein increased, carbon dioxide decreased, chest x-ray abnormal, condition aggravated, drug trough level, fibrin d dimer, full blood count abnormal, hemofiltration, hemoglobin decreased, heart transplant, immunosuppressant drug therapy, infection, international normalized ratio increased, liver function test normal, lung assist device therapy, lung opacity, mean cell volume normal, neutrophil count, platelet count decreased, platelet-large cell ratio, positron emission tomogram, prothrombin time prolonged, right ventricular dysfunction, sars-cov-2 test positive, tachycardia, troponin, urinary sediment, urine analysis, white blood cell count decreased, and asthenia, chills, dyspnea, pneumonia, exposure to sars-cov-2, pyrexia, respiratory failure, sepsis, and covid-19, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000210535. 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 product quality complaint (PQC) evaluation/investigation performed.  Additional information received from Complaint department on 14-JAN-2022 The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: information regarding product quality complaint result & does not alter the assessment of prior causality of reported events. : 20220100199-COVID-19 VACCINE AD26.COV2.S AKI,thrombocytopenia,pancytopenia,hyperkalemia,hypoxia,ALT normal,c-ANCA,AST normal,ALP normal,bili normal,Cl increased,Creat increased,blood glucose normal,blood lactic acid,blood Mg normal,blood K increased,blood Na normal,blood urea increased,brain natriuretic peptide increased,CRP increased,CO2 decreased,chest x-ray abnormal,condition aggravated,drug trough level,fibrin d dimer,full blood count abnormal,hemofiltration, Hb decreased,heart transplant,immunosuppressant drug therapy,infection,INR increased,LFT normal,lung assist device therapy,lung opacity,mean cell volume normal,neutrophil count,platelet count decreased,platelet-large cell ratio,PET,PT prolonged,right ventricular dysfunction,sars-cov-2 test positive,tachycardia,troponin,urinary sediment,urine analysis,wbc count decreased,asthenia,chills,dyspnea,pneumonia,exposure to sars-cov-2,pyrexia,respiratory failure, sepsis,covid-19. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, &has unknown scientific plausibility. There is no information on any other factors potentially associated with the event 20220100199-COVID-19 VACCINE AD26.COV2.S-cardiac sarcoidosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled,& has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY [Sarcoidosis] 20220100199-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, & has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS