Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Anaemia
Clinical narrative: Urinary tract infection; Sepsis; falls at home; Back pain; Unsteady on his feet; Right upper quadrant (RUQ) pain; Hypotensive; Acute chronic anemia; Hypophosphatemia; Pleural effusion; increased sputum production/ cough; focal mild active colitis; Enlarging supraclavicular; Acute kidney injury; Deep vein thrombosis; This spontaneous case was reported by a physician and describes the occurrence of SEPSIS (Sepsis), URINARY TRACT INFECTION (Urinary tract infection), ACUTE KIDNEY INJURY (Acute kidney injury) and DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Basosquamous carcinoma of skin (on face) in 2017, Rash in August 2020, Nausea in August 2020, Pyrexia in August 2020 and Barrett's oesophagus. Concurrent medical conditions included Sleep apnoea syndrome since 2016, Fatigue since 2016, Dyspnoea since 2017, Vomiting since 2017, Oedema lower limb (lower extremity edema) since 2019, Constipation since 10-Aug-2020, Atrial fibrillation paroxysmal (controlled) since August 2020, Hypokalaemia since 04-Sep-2020, Gastrooesophageal reflux disease, Hypertension, Obesity, Anxiety and Mesothelioma (locally advanced mesothelioma of right lung pleura) since 28-Sep-2017. Concomitant products included DILTIAZEM from 20-Feb-2016 to an unknown date, FLECAINIDE from 11-Mar-2016 to an unknown date, LORAZEPAM from 24-Oct-2017 to an unknown date, LOSARTAN from 29-Sep-2017 to an unknown date, ONDANSETRON from 28-Sep-2017 to an unknown date, POTASSIUM CHLORIDE, PROCHLORPERAZINE from 11-Jun-2019 to an unknown date, WARFARIN from 30-Jan-2016 to an unknown date, LIDOCAINE, PRILOCAINE (LIDOCAINE/PRILOCAINE), VANCOMYCIN from 09-Dec-2020 to an unknown date, POTASSIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC, SODIUM PHOSPHATE MONOBASIC (ANHYDROUS) (K-PHOS NEUTRAL) from 09-Dec-2020 to an unknown date, OXYCODONE from 28-Jan-2021 to an unknown date and APIXABAN from 17-Feb-2021 to an unknown date for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 22-Feb-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), FALL (falls at home), BACK PAIN (Back pain), GAIT DISTURBANCE (Unsteady on his feet), ABDOMINAL PAIN UPPER (Right upper quadrant (RUQ) pain), HYPOTENSION (Hypotensive), ANAEMIA (Acute chronic anemia), HYPOPHOSPHATAEMIA (Hypophosphatemia), PLEURAL EFFUSION (Pleural effusion), PRODUCTIVE COUGH (increased sputum production/ cough), COLITIS (focal mild active colitis) and LYMPHADENOPATHY (Enlarging supraclavicular). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 milligram once a day; CEFEPIME HYDROCHLORIDE (MAXIPIME) (intravenous) at a dose of 2000 milligram once a day; CELECOXIB (CELEBREX) (oral) for Back pain, at a dose of 200 milligram twice a day and CEFEPIME at an unspecified dose and frequency. At the time of the report, SEPSIS (Sepsis), URINARY TRACT INFECTION (Urinary tract infection), DEEP VEIN THROMBOSIS (Deep vein thrombosis), FALL (falls at home), BACK PAIN (Back pain), GAIT DISTURBANCE (Unsteady on his feet), ABDOMINAL PAIN UPPER (Right upper quadrant (RUQ) pain), HYPOTENSION (Hypotensive), ANAEMIA (Acute chronic anemia), HYPOPHOSPHATAEMIA (Hypophosphatemia), PLEURAL EFFUSION (Pleural effusion), PRODUCTIVE COUGH (increased sputum production/ cough), COLITIS (focal mild active colitis) and LYMPHADENOPATHY (Enlarging supraclavicular) outcome was unknown and ACUTE KIDNEY INJURY (Acute kidney injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood albumin (5.0-3.5 gram per decilitre): 3.1 gram per decilitre. On 22-Feb-2021, Blood alkaline phosphatase (39-117 U/L): 135 U/L. On 22-Feb-2021, Blood bilirubin (1.3-0.1 milligram per decilitre): 1.4 milligram per decilitre. On 22-Feb-2021, Blood calcium (10.2-8.4 milligram per decilitre): 8.1 milligram per decilitre. On 22-Feb-2021, Blood glucose (99-70 milligram per decilitre): 109 milligram per decilitre. On 22-Feb-2021, Blood phosphorus (5.0-2.5 milligram per decilitre): 1.4 milligram per decilitre. On 22-Feb-2021, C-reactive protein: 188.1 milligram per litre. On 22-Feb-2021, Carbon dioxide (22-30 millimole per litre): 21 millimole per litre. On 22-Feb-2021, Chest X-ray: single view showed Improved patchy opacity at the right lung base with improved small right-sided pleural effusion. On 22-Feb-2021, Haematocrit (53.0-40.8 %): 25.8 %. On 22-Feb-2021, Haemoglobin (18.1-13.4 gram per decilitre): 8.4 gram per decilitre. On 22-Feb-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.4 billion per litre. On 22-Feb-2021, Mean cell haemoglobin (36.0-32.0 gram per decilitre): 31.3 gram per decilitre. On 22-Feb-2021, Red blood cell count (4.41-6.07 10^12/L): 2.68 10^12/L. On 22-Feb-2021, Red cell distribution width (15.1-10.9 %): 18.7 %. On 22-Feb-2021, Urine analysis: protein 30 mg/dL (reference range = negative), blood trace (reference range negative) thought to be secondary to gemcitabine, and mucus trace microscopic (HPF) (reference range = negative/HPF). On 24-Feb-2021, Blood culture: (Negative) Negative. On 24-Feb-2021, Haematocrit (53.0-40.8 %): 21.7 %. On 24-Feb-2021, Vital signs measurement: were blood pressure 102/54 mmHg, pulse 71 bpm, temperature 36 degrees Celsius, respiratory rate 20, breaths/min, and SpO2 93 %. On 27-Feb-2021, Bilirubin conjugated (0.2-0.0 milligram per decilitre): 0.5 milligram per decilitre. On 27-Feb-2021, Blood albumin (5.0-3.5 gram per decilitre): 2.3 gram per decilitre. On 27-Feb-2021, Blood calcium (10.2-8.4 milligram per decilitre): 7.2 milligram per decilitre. On 27-Feb-2021, Blood chloride (98-108 millimole per litre): 109 millimole per litre. On 27-Feb-2021, Blood creatinine (1.30-0.70 milligram per decilitre): 1.53 milligram per decilitre. On 27-Feb-2021, Blood iron (45-160 microgram per decilitre): 23 microgram per decilitre. On 27-Feb-2021, Blood lactic acid (0.5-2.2 millimole per litre): 3.3 millimole per litre. On 27-Feb-2021, Blood phosphorus (5.0-2.5 milligram per decilitre): 1.6 milligram per decilitre. On 27-Feb-2021, Blood urea (25-7 milligram per decilitre): 57 milligram per decilitre. On 27-Feb-2021, Brain natriuretic peptide (1-100 picogram per decilitre): 138 picogram per decilitre. On 27-Feb-2021, Carbon dioxide (22-30 millimole per litre): 20 millimole per litre. On 27-Feb-2021, Chest X-ray: Cardiomediastinal silhouette and right IJ Mediport catheter unchanged. No significant change in loculated appearing right pleural effusion and sub-pleural right lower lung lobe report from 21-Feb-2021. No pneumothorax. Negative upper abdomen. On 27-Feb-2021, Granulocyte count (0.05-0.0 billion per litre): 0.2 billion per litre. On 27-Feb-2021, Haematocrit (53.0-40.8 %): 20.8 %. On 27-Feb-2021, Haemoglobin (18.1-13.4 gram per decilitre): 6.8 gram per decilitre. On 27-Feb-2021, International normalised ratio: 3.5. On 27-Feb-2021, Iron binding capacity total (284-507 microgram per decilitre): 120 microgram per decilitre. On 27-Feb-2021, Iron binding capacity unsaturated (124-462 microgram per decilitre): 97 microgram per decilitre. On 27-Feb-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.6 billion per litre. On 27-Feb-2021, Polymerase chain reaction: (Negative) Negative. On 27-Feb-2021, Protein total (8.9-6.4 gram per decilitre): 5.3 gram per decilitre. On 27-Feb-2021, Prothrombin time (12.2-14.1 Second): 34.0 Second. On 27-Feb-2021, Red blood cell count (4.41-6.07 10^12/L): 2.24 10^12/L. On 27-Feb-2021, Red cell distribution width (15.1-10.9 %): 19.1 %. On 27-Feb-2021, Reticulocyte count (1.8-0.5 %): 1.9 %. On 27-Feb-2021, Reticulocyte haemoglobin equivalent (30.0-38.5 picogram): 25.8 picogram. On 27-Feb-2021, Troponin: 57.4 ng/L. On 27-Feb-2021, Urine analysis: slightly cloudy (normal clear) protein urine 100 mg/dL (normal negative), hyaline casts 11-30 (normal range 0-5/LPF) and granular casts 11-30 (normal range none seen/LPF). On 27-Feb-2021, Vital signs measurement: Vital signs at discharge were blood pressure 131/60 mmHg, pulse 80 bpm, temperature 37 degrees Celsius, respiratory rate 20 breaths/min, and SpO2 92 %. On 28-Feb-2021, Blood urea (25-7 milligram per decilitre): 42 milligram per decilitre. On 28-Feb-2021, Granulocyte count (0.05-0.0 billion per litre): 0.2 billion per litre. On 28-Feb-2021, Haematocrit (53.0-40.8 %): 22.8 %. On 28-Feb-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.5 gram per decilitre. On 28-Feb-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.7 billion per litre. On 28-Feb-2021, Polymerase chain reaction: (Negative) Negative. On 28-Feb-2021, Red blood cell count (4.41-6.07 10^12/L): 2.45 10^12/L. On 28-Feb-2021, Red cell distribution width (15.1-10.9 %): 18.6 %. On 01-Mar-2021, Activated partial thromboplastin time (23.2-34.7 Second): 39.9 Second. On 01-Mar-2021, Bilirubin conjugated (0.2-0.0 milligram per decilitre): 0.7 milligram per decilitre. On 01-Mar-2021, Blood albumin (5.0-3.5 gram per decilitre): 2.2 gram per decilitre. On 01-Mar-2021, Blood alkaline phosphatase (39-117 U/L): 127 U/L. On 01-Mar-2021, Blood calcium (10.2-8.4 milligram per decilitre): 8.1 milligram per decilitre. On 01-Mar-2021, Blood chloride (98-108 millimole per litre): 11 millimole per litre. On 01-Mar-2021, Blood fibrinogen (400-150 milligram per decilitre): 834 milligram per decilitre. On 01-Mar-2021, Blood lactate dehydrogenase (124-271 U/L): 662 U/L. On 01-Mar-2021, Blood urea (25-7 milligram per decilitre): 28 milligram per decilitre. On 01-Mar-2021, Echocardiogram: showed the left ventricle was normal in size, thickness and function was within normal limits, calculated biplane ejection fraction (EF) was 63.1%. There were no regional wall abnormalities noted. There was no evidence of left ventricular diastolic dysfunction. The left atrium was normal in size, left atrial pressure was normal. On 01-Mar-2021, Fibrin D dimer: 3100 3100 FEU. On 01-Mar-2021, Granulocyte count (0.05-0.0 billion per litre): 0.4 billion per litre. On 01-Mar-2021, Haematocrit (53.0-40.8 %): 23.3 %. On 01-Mar-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.6 gram per decilitre. On 01-Mar-2021, Haptoglobin (195-36 milligram per decilitre): 324 milligram per decilitre. On 01-Mar-2021, International normalised ratio: 2.1. On 01-Mar-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.9 billion per litre. On 01-Mar-2021, Protein total (8.9-6.4 gram per decilitre): 5.5 gram per decilitre. On 01-Mar-2021, Prothrombin time (12.2-14.1 Second): 22.8 Second. On 01-Mar-2021, Red blood cell count (4.41-6.07 10^12/L): 2.53 10^12/L. On 01-Mar-2021, Red cell distribution width (15.1-10.9 %): 18.8 %. On 01-Mar-2021, Reticulocyte count (1.8-0.5 %): 39.1 %. On 01-Mar-2021, Reticulocyte haemoglobin equivalent (30.0-38.5 picogram): 26.1 picogram. On 05-Mar-2021, Blood culture: (Negative) Negative. On 05-Mar-2021, Chest X-ray: Stable right chest wall chemotherapy port. Stable cardiomediastinal silhouette. Loculated right pleural effusion and right basilar scarring/pleural thickening were unchanged. Left lung was clear. Stable osseous structures. On 05-Mar-2021, Culture urine: (Negative) Negative. On 05-Mar-2021, Echocardiogram: ECG abnormal, sinus or ectopic atrial rhythm, ventricular premature complex, borderline left axis deviation, IVCD considered atypical RBBB, significant change in rhythm. On 05-Mar-2021, Granulocyte count (0.05-0.0 billion per litre): 0.3 billion per litre. On 05-Mar-2021, Haematocrit (53.0-40.8 %): 24.9 %. On 05-Mar-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.4 gram per decilitre. On 05-Mar-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.8 billion per litre. On 05-Mar-2021, Mean cell haemoglobin (36.0-32.0 gram per decilitre): 29.7 gram per decilitre. On 05-Mar-2021, Neutrophil count (6.6-1.8 billion per litre): 8.8 billion per litre. On 05-Mar-2021, Polymerase chain reaction: (Negative) Negative. On 05-Mar-2021, Red blood cell count (4.41-6.07 10^12/L): 2.61 10^12/L. On 05-Mar-2021, Red cell distribution width (15.1-10.9 %): 18.4 %. On 05-Mar-2021, Urine analysis: urine turbid (normal clear), protein urine greater than 500 mg/dL (normal negative), urobilinogen urine 4.0 EU/dL (normal range <2.0), white blood cells in urine 6-10/ HPF (normal range 0-5), bacteria urine many/HPF (normal none seen/HPF), hyaline casts 11-30 (normal range 0-5/LPF) and granular casts 6-10 (normal range none seen/LPF). On 06-Mar-2021, Blood calcium (10.2-8.4 milligram per decilitre): 8.0 milligram per decilitre. On 06-Mar-2021, Blood culture: (Negative) Negative. On 06-Mar-2021, Blood lactate dehydrogenase (124-271 U/L): 531 U/L. On 06-Mar-2021, Blood magnesium (2.6-1.6 milligram per decilitre): 1.5 milligram per decilitre. On 06-Mar-2021, Blood phosphorus (5.0-2.5 milligram per decilitre): 2.2 milligram per decilitre. On 06-Mar-2021, Computerised tomogram: Extensive right pleural abnormalities consistent with known mesothelioma, with fluid and soft tissue components appearing slightly increased as compared with February 2000 2021. No suggestion of empyema. Interval development tiny left pleural effusion. Interval enlargement in likely metastatic supraclavicular and mediastinal nodes. Previously seen non-occlusive deep vein thrombosis confluence left subclavian and internal jugular veins appears resolved. Indeterminate small splenic hypodensity appeared somewhat increased. On 06-Mar-2021, Granulocyte count (0.05-0.0 billion per litre): 0.2 billion per litre. On 06-Mar-2021, Haematocrit (53.0-40.8 %): 24.3 %. On 06-Mar-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.7 gram per decilitre. On 06-Mar-2021, Haptoglobin (195-36 milligram per decilitre): 379 milligram per decilitre. On 06-Mar-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.4 billion per litre. On 06-Mar-2021, Mean cell haemoglobin (36.0-32.0 gram per decilitre): 31.7 gram per decilitre. On 06-Mar-2021, Neutrophil count (6.6-1.8 billion per litre): 8.2 billion per litre. On 06-Mar-2021, Red blood cell count (4.41-6.07 10^12/L): 2.33 10^12/L. On 06-Mar-2021, Reticulocyte count (1.8-0.5 %): 28.7 %. On 06-Mar-2021, Reticulocyte haemoglobin equivalent (30.0-38.5 picogram): 26.3 picogram. On 06-Mar-2021, White blood cell count (11.1-4.0 billion per litre): 11.5 billion per litre. On 07-Mar-2021, Blood magnesium (2.6-1.6 milligram per decilitre): 1.4 milligram per decilitre. On 07-Mar-2021, Blood phosphorus (5.0-2.5 milligram per decilitre): 2.3 milligram per decilitre. On 07-Mar-2021, Blood potassium (3.5-5.1 millimole per litre): 3.2 millimole per litre. On 07-Mar-2021, Granulocyte count (0.05-0.0 billion per litre): 0.2 billion per litre. On 07-Mar-2021, Haematocrit (53.0-40.8 %): 24.7 %. On 07-Mar-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.7 gram per decilitre. On 07-Mar-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.8 billion per litre. On 07-Mar-2021, Neutrophil count (6.6-1.8 billion per litre): 9.9 billion per litre. On 07-Mar-2021, Red cell distribution width (15.1-10.9 %): 18.8 %. On 07-Mar-2021, Reticulocyte count (1.8-0.5 %): 3.1 %. On 07-Mar-2021, White blood cell count (11.1-4.0 billion per litre): 11.8 billion per litre. On 08-Mar-2021, Alanine aminotransferase (7-52 U/L): 6 U/L. On 08-Mar-2021, Blood albumin (5.0-3.5 gram per decilitre): 2.2 gram per decilitre. On 08-Mar-2021, Blood alkaline phosphatase (39-117 U/L): 128 U/L. On 08-Mar-2021, Blood creatinine (1.30-0.70 milligram per decilitre): 0.60 milligram per decilitre. On 08-Mar-2021, Blood phosphorus (5.0-2.5 milligram per decilitre): 2.3 milligram per decilitre. On 08-Mar-2021, Haematocrit (53.0-40.8 %): 22.4 %. On 08-Mar-2021, Haemoglobin (18.1-13.4 gram per decilitre): 7.1 gram per decilitre. On 08-Mar-2021, International normalised ratio: 1.8. On 08-Mar-2021, Lymphocyte count (3.8-0.8 billion per litre): 0.8 billion per litre. On 08-Mar-2021, Mean cell haemoglobin (36.0-32.0 gram per decilitre): 31.7 gram per decilitre. On 08-Mar-2021, Neutrophil count (6.6-1.8 billion per litre): 7.3 billion per litre. On 08-Mar-2021, Protein total (8.9-6.4 gram per decilitre): 5.4 gram per decilitre. On 08-Mar-2021, Prothrombin time (12.2-14.1 Second): 20.0 Second. On 08-Mar-2021, Red cell distribution width (15.1-10.9 %): 18.6 %. On 08-Mar-2021, Ultrasound Doppler: evidence of deep vein thrombosis in either the right or the left lower extremity. On 08-Mar-2021, Viral test: positive for cytomegalovirus (CMV) IgM antibody test, parvovirus lgM and Epstein Barr virus acute panel test IgG. In March 2021, Blood calcium (10.2-8.4 milligram per decilitre): 7.6 milligram per decilitre. In March 2021, C-reactive protein: 108 milligram per litre. In March 2021, Faecal calprotectin: (Positive) Positive. In March 2021, Gamma-glutamyltransferase: Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 17Mar21, physical examination indicated the Pt was chronically ill-appearing, fatigued, and in no apparent distress with edema. On the same day, the Pt was discharged from the hospital in stable condition. Final diagnoses included fever, the Pt had had a broad work up, including infectious disease (ID) consult mostly negative: blood exam, urine culture, GI PCR, CT C/A/P, flexible sigmoidoscopy. The Pt did have positive CMV lgM, parvovirus lgM so could have had a viral illness vs false positive, very elevated rheumatoid factor. The Pt had completed a 5-day course of ceftriaxone and metronidazole. Erythrocyte sedimentation rate (ESR) 73, CRP 108. Suspected tumor fever vs possible granulomatous process. The Pt had enlarging supraclavicular (SC), mediastinal lymph nodes (LNs), splenic lesion, and prior splenic granuloma. Also, with enlarged liver, rising AP, so may also have hepatic involvement of this process. Interventional radiology (IR) referral was placed for outPt biopsy. Diarrhea, flexible sigmoidoscopy showed focal mild active colitis. GI PCR negative. Could be post infectious from prior C. difficile in Dec/2020. Positive fecal calprotectin. Fecal elastase normal. Fecal fat and celiac panel pending. Deconditioning, physical therapy (PT)/ occupational therapy (OT) following on deconditioning, recommended home therapies. Vitamin A deficiency, unusual, stool studies negative for pancreatic insufficiency. Could be related to liver process as vitamin A is stored in the liver. Depleting vitamin A for 14 days. Elevated AP/ gamma-glutamyltransferase (GGT), liver enlarged to 24 cm on CT but with normal texture. No masses, no biliary obstruction on ultrasound and CT. No new medications except vitamin supplements. Suspect possible granulomatous or infiltrative liver disease. Would need LFT check in a week. Vitamin D deficiency continue ergocalciferol. Anemia due to chronic disease (CD); ferritin 1646, prolonged hospitalization with frequent phlebotomy.  The symptoms of sepsis included Fatigue and Pyrexia, Tachycardia, Dyspnoea, Malaise, asthenia, Myalgia, Confusional state, Lethargy, Decreased appetite. The patient's laboratory findings included aneurysm, Splenic lesion, splenic granuloma, Spondyloarthropathy, Tricuspid valve incompetence, Hepatomegaly. The symptoms of Colitis included Diarrhoea. The symptoms of Urinary tract infection included Dysuria. The Patient experience high blood pressure in 90's. Patient also experience Immunization reaction, Inflammation, feeling abnormal, Discomfort, Illness. The patient's diagnosis includes  intraabdominal infection and neutropenic fever. The symptoms of Acute kidney injury included Dyspnoea, Dyspnoea exertional, Oedema peripheral, Tachypnoea, and Orthopnea. On 20-Feb-2021, received fourth dose of mRNA-1273, to change fourth dose to second dose.  Company comment: This spontaneous case concerns a 71-year-old male patient, with relevant medical history of dyspnea, lower extremity edema, paroxysmal AF-controlled, GERD, hypertension, obese, hypokalemia, Barrett esophagus, obstructive sleep apnea syndrome, fatigue, and anxiety, with concomitant Vancomycin and Losartan, enrolled in the study and in the treatment at the time of the events, who experienced the unexpected serious medically significant AESI of Sepsis that occurred 2 days, AESIs Acute kidney injury and Deep vein thrombosis 7 days , and Urinary tract infection after receiving the 2nd dose of mRNA-1273 vaccine. Patient was enrolled in the study and in treatment at the time of the events. Patient received 2nd dose of the mRNA-1273 vaccine on 20-Feb-2021. On 22-Feb-2021, patient had fatigue and fever. In ER, patient complaint of fatigue, dyspnea, and body aches, and tachycardic above 100 bpm, dyspnea with exertion, with temperature 102.2 °F, BP high 90's, which met the criteria for sepsis. Relevant laboratory test showed decreased hemoglobin, hematocrit, elevated protein in urine, elevated C-reactive protein (CRP), SARS-CoV-2 test negative, Chest X-ray showed improved patchy opacity at the right lung base with improved small right-sided pleural effusion. Subsequently admitted to the hospital and started on Tylenol, Maxipime and vancomycin. On 23-Feb, reported worsening back pain increased with walking. A plan to discontinue his empiric antibiotics and monitor his blood cultures was made and his last dose of vancomycin was on (23-Feb), which he had been taking orally for 6 total weeks of treatment. And was discharged after 2 days of hospitalization. On 27-Feb, had fever, fatigue, and fall and re-admitted for treatment. Reported right upper quadrant abdominal pain that started overnight. On admission, patient was hypotensive, tachypneic, dyspneic on exertion and orthopneic, and with lower extremity edema and was found to have acute chronic anemia and acute kidney injury. The AKI resolved overnight after IVF and 1unit PRBC transfusion. Repeat hemolysis test and labs showed elevated haptoglobin, lactate dehydrogenase (LDH) fibrinogen and D-dimer, with recent deep vein thrombosis and started on anticoagulants. Lab tests showed decreased hemoglobin hematocrit, cloudy urine with elevated protein, low eGFR. On March1, patient was discharged feeling a bit better, and quite weak. The subject was following up for treatment after his recent discharge. The treating MD sent him to the emergency department to be evaluated for his continuing fever and fatigue. And was admitted on 05-March, presented with back pain, difficulty urinating, fatigue and concern for a sepsis alert and being worked up for active infections. PE findings included tachypnea, diminished breath sounds in the bases, mild abdominal TTP without rebound or guarding, trace lower extremities edema, rash. Patient was admitted to Medical Oncology with differential diagnoses of sepsis, UTI, intraabdominal infection, medication reaction, neutropenic fever. Lab test showed, turbid urine with signs of infection, with elevated protein; blood cultures were negative. On 07-March, subject was improving, while on antibiotics. Lab tests: Blood and urine cultures negative; gastrointestinal panel test normal, positive CMV IgM antibody test and EBV acute panel test IgG; given preliminary positive HIV and possible active CMV, no evidence of DVT in doppler, subject underwent a flexible sigmoidoscopy, thoracentesis. On 17-March, discharged from the hospital in stable condition and completed a 5-day course of Ceftriaxone and Metronidazole. Multiple co-morbidities could be considered as risk factors and concomitant Vancomycin and Losartan remain as confounders for acute kidney injury. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-607859 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old male patient, with relevant medical history of dyspnea, lower extremity edema, paroxysmal AF-controlled, GERD, hypertension, obese, hypokalemia, Barrett esophagus, obstructive sleep apnea syndrome, fatigue, and anxiety, with concomitant Vancomycin and Losartan, enrolled in the study and in the treatment at the time of the events, who experienced the unexpected serious medically significant AESI of Sepsis that occurred 2 days, AESIs Acute kidney injury and Deep vein thrombosis 7 days , and Urinary tract infection after receiving the 2nd dose of mRNA-1273 vaccine. Patient was enrolled in the study and in treatment at the time of the events. Patient received 2nd dose of the mRNA-1273 vaccine on 20-Feb-2021. On 22-Feb-2021, patient had fatigue and fever. In ER, patient complaint of fatigue, dyspnea, and body aches, and tachycardic above 100 bpm, dyspnea with exertion, with temperature 102.2 °F, BP high 90's, which met the criteria for sepsis. Relevant laboratory test showed decreased hemoglobin, hematocrit, elevated protein in urine, elevated C-reactive protein (CRP), SARS-CoV-2 test negative, Chest X-ray showed improved patchy opacity at the right lung base with improved small right-sided pleural effusion. Subsequently admitted to the hospital and started on Tylenol, Maxipime and vancomycin. On 23-Feb, reported worsening back pain increased with walking. A plan to discontinue his empiric antibiotics and monitor his blood cultures was made and his last dose of vancomycin was on (23-Feb), which he had been taking orally for 6 total weeks of treatment. And was discharged after 2 days of hospitalization. On 27-Feb, had fever, fatigue, and fall and re-admitted for treatment. Reported right upper quadrant abdominal pain that started overnight. On admission, patient was hypotensive, tachypneic, dyspneic on exertion and orthopneic, and with lower extremity edema and was found to have acute chronic anemia and acute kidney injury. The AKI resolved overnight after IVF and 1unit PRBC transfusion. Repeat hemolysis test and labs showed elevated haptoglobin, lactate dehydrogenase (LDH) fibrinogen and D-dimer, with recent deep vein thrombosis and started on anticoagulants. Lab tests showed decreased hemoglobin hematocrit, cloudy urine with elevated protein, low eGFR. On March1, patient was discharged feeling a bit better, and quite weak. The subject was following up for treatment after his recent discharge. The treating MD sent him to the emergency department to be evaluated for his continuing fever and fatigue. And was admitted on 05-March, presented with back pain, difficulty urinating, fatigue and concern for a sepsis alert and being worked up for active infections. PE findings included tachypnea, diminished breath sounds in the bases, mild abdominal TTP without rebound or guarding, trace lower extremities edema, rash. Patient was admitted to Medical Oncology with differential diagnoses of sepsis, UTI, intraabdominal infection, medication reaction, neutropenic fever. Lab test showed, turbid urine with signs of infection, with elevated protein; blood cultures were negative. On 07-March, subject was improving, while on antibiotics. Lab tests: Blood and urine cultures negative; gastrointestinal panel test normal, positive CMV IgM antibody test and EBV acute panel test IgG; given preliminary positive HIV and possible active CMV, no evidence of DVT in doppler, subject underwent a flexible sigmoidoscopy, thoracentesis. On 17-March, discharged from the hospital in stable condition and completed a 5-day course of Ceftriaxone and Metronidazole. Multiple co-morbidities could be considered as risk factors and concomitant Vancomycin and Losartan remain as confounders for acute kidney injury. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.