Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood osmolarity decreased, Blood potassium, Blood potassium normal, Blood pressure increased, Blood pressure measurement
Clinical narrative: AST ALT RATIO; HEPATIC CANCER; ALANINE AMINOTRANSFERASE INCREASED; HEPATITIS C; ANION GAP; INTESTINAL ISCHAEMIA; BASOPHIL COUNT DECREASED; GASTROINTESTINAL OEDEMA; BASOPHIL PERCENTAGE DECREASED; NEPHROLITHIASIS; BILIRUBIN CONJUGATED INCREASED; DRUG ABUSE; BLOOD ALBUMIN DECREASED; AST ALT RATIO; BLOOD ALKALINE PHOSPHATASE NORMAL; ABDOMINAL DISCOMFORT; BLOOD BILIRUBIN INCREASED; ABDOMINAL DISTENSION; BLOOD CALCIUM DECREASED; ABDOMINAL PAIN; BLOOD CHLORIDE NORMAL; ALANINE AMINOTRANSFERASE INCREASED; BLOOD CREATININE NORMAL; ALCOHOL ABUSE; BLOOD GLUCOSE NORMAL; ANION GAP; BLOOD OSMOLARITY DECREASED; ANTICOAGULANT THERAPY; BLOOD POTASSIUM NORMAL; ARTERIOSCLEROSIS; BLOOD SODIUM DECREASED; AUSCULTATION; BLOOD UREA INCREASED; BASOPHIL COUNT DECREASED; BLOOD UREA NITROGEN CREATININE RATIO; BASOPHIL PERCENTAGE DECREASED; ASPARTATE AMINOTRANSFERASE INCREASED; BRADYCARDIA; CARBON DIOXIDE DECREASED; BLOOD ALKALINE PHOSPHATASE NORMAL; CREATININE RENAL CLEARANCE; BLOOD OSMOLARITY DECREASED; EOSINOPHIL COUNT NORMAL; BLOOD PRESSURE INCREASED; EOSINOPHIL PERCENTAGE; BLOOD SODIUM DECREASED; GLOMERULAR FILTRATION RATE NORMAL; CARBON DIOXIDE DECREASED; GRANULOCYTE PERCENTAGE; CHOLELITHIASIS; HAEMATOCRIT DECREASED; COMPUTERISED TOMOGRAM THORAX ABNORMAL; HAEMOGLOBIN NORMAL; CONSTIPATION; IMMATURE GRANULOCYTE COUNT; GRANULOCYTE PERCENTAGE; MEAN CELL HAEMOGLOBIN CONCENTRATION NORMAL; INFUSION; MEAN CELL HAEMOGLOBIN NORMAL; LABORATORY TEST; MEAN CELL VOLUME NORMAL; LIVER DISORDER; MEAN PLATELET VOLUME NORMAL; LYMPHOCYTE COUNT NORMAL; MONOCYTE COUNT INCREASED; LYMPHOCYTE PERCENTAGE DECREASED; MONOCYTE PERCENTAGE; MALNUTRITION; NEUTROPHIL COUNT INCREASED; MEAN CELL VOLUME NORMAL; NEUTROPHIL PERCENTAGE INCREASED; MEAN PLATELET VOLUME NORMAL; PROTEIN TOTAL DECREASED; PAIN; RED BLOOD CELL COUNT NORMAL; PLATELET COUNT DECREASED; RED CELL DISTRIBUTION WIDTH; PLEURAL EFFUSION; RED CELL DISTRIBUTION WIDTH INCREASED; PROTEIN TOTAL DECREASED; LYMPHOCYTE COUNT NORMAL; HYPOPHAGIA; LYMPHOCYTE PERCENTAGE DECREASED; IMMATURE GRANULOCYTE COUNT; NUCLEATED RED CELLS; MONOCYTE PERCENTAGE; PLATELET COUNT DECREASED; NUCLEATED RED CELLS; TRANSAMINASES INCREASED; VARICES OESOPHAGEAL; WHITE BLOOD CELL COUNT INCREASED; NAUSEA; VOMITING; NAUSEA; MEAN CELL HAEMOGLOBIN CONCENTRATION NORMAL; VARICES OESOPHAGEAL; WHITE BLOOD CELL COUNT INCREASED; PLEURAL EFFUSION; OSTEOARTHRITIS; OSTEOARTHRITIS; NEUTROPHIL COUNT INCREASED; PAIN; NEUTROPHIL PERCENTAGE INCREASED; MALNUTRITION; INFLAMMATORY MARKER TEST; SARS-COV-2 TEST POSITIVE; RED CELL DISTRIBUTION WIDTH; SPLENOMEGALY; SUBSTANCE USE; TOBACCO ABUSE; TRANSAMINASES INCREASED; NORMOCYTIC ANAEMIA; MONOCYTE COUNT INCREASED; INFLAMMATORY MARKER TEST; GYNAECOMASTIA; INFUSION; HAEMATOCRIT DECREASED; LABORATORY TEST; HEPATIC MASS; LIVER DISORDER; HYPONATRAEMIA; HEPATIC MASS; EOSINOPHIL COUNT NORMAL; HYPONATRAEMIA; FLATULENCE; HYPOPHAGIA; GLOMERULAR FILTRATION RATE NORMAL; GYNAECOMASTIA; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; BLOOD CHLORIDE NORMAL; CONSTIPATION; BLOOD CREATININE NORMAL; CORONARY ARTERY DISEASE; BLOOD GLUCOSE NORMAL; ESSENTIAL HYPERTENSION; BLOOD UREA INCREASED; FLATULENCE; BLOOD UREA NITROGEN CREATININE RATIO; CHOLELITHIASIS; BLOOD BILIRUBIN INCREASED; AUSCULTATION; PERITONITIS BACTERIAL; COVID-19; BLOOD ALBUMIN DECREASED; BLOOD PRESSURE INCREASED; ASPARTATE AMINOTRANSFERASE INCREASED; ANTICOAGULANT THERAPY; ASCITES; ARTERIOSCLEROSIS; SEPSIS; ALCOHOL ABUSE; HYPERBILIRUBINAEMIA; ABDOMINAL DISCOMFORT; THROMBOCYTOPENIA; ABDOMINAL DISTENSION; HEPATIC CIRRHOSIS; ABDOMINAL PAIN; REGENERATIVE SIDEROTIC HEPATIC NODULE; PERITONITIS BACTERIAL; NORMOCYTIC ANAEMIA; HEPATIC CANCER; CORONARY ARTERY DISEASE; SEPSIS; RED CELL DISTRIBUTION WIDTH INCREASED; HEPATIC CIRRHOSIS; CREATININE RENAL CLEARANCE; THROMBOCYTOPENIA; TOBACCO ABUSE; SMALL INTESTINAL OBSTRUCTION; SARS-COV-2 TEST POSITIVE; INTESTINAL ISCHAEMIA; HAEMOGLOBIN NORMAL; HEPATITIS C; EOSINOPHIL PERCENTAGE; BRADYCARDIA; BILIRUBIN CONJUGATED INCREASED; ASCITES; SMALL INTESTINAL OBSTRUCTION; GASTROINTESTINAL OEDEMA; COVID-19; HYPERBILIRUBINAEMIA; ESSENTIAL HYPERTENSION; REGENERATIVE SIDEROTIC HEPATIC NODULE; RED BLOOD CELL COUNT NORMAL; NEPHROLITHIASIS; MEAN CELL HAEMOGLOBIN NORMAL; DRUG ABUSE; BLOOD POTASSIUM NORMAL; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; BLOOD CALCIUM DECREASED; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2399106) on 12-AUG-2022 and concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: drug abuse (methamphetamine use, Marijuana use), hypertensive disorder/hypertension, alcohol user (Drank for 47 years and quit in 2019, sober for 3 years), and tobacco abuse, and concurrent conditions included: viral hepatitis c, and arthritis, and other pre-existing medical conditions included: The patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 29-DEC-2021 for an unspecified indication. Age at time of vaccination 57 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 26-JUL-2022, the patient experienced suspected small bowel obstruction. On presentation to hospital patient was found to be covid-19 positive (covid-19 infection without hypoxia). The internal medicine team was consulted in the care of patient for his continued abdominal complaints despite treatment complicated by his covid-19 positive status. Patient was hospitalized on an unspecified date for 6 days. Patient attempted to consume a full liquid diet but did not tolerate. Patient had significant abdominal pain overnight requiring Dilaudid. Patient experienced a lot of abdominal cramping and discomfort. The pain was primarily in the lower quadrants of the abdomen and any pressure in the lower quadrants made the pain worse. The Dilaudid helped the and patient was able to sleep overnight with the pain medication. No stool was been passed recently at time of report. It was reported that some gas was passed but was minimal. Patient did not have any episodes of emesis. Patient denied fever, chills, palpitations, chest pain, lower extremity edema, dyspnea, cough, sputum production, nausea, vomiting, constipation, diarrhea, dysuria or hematuria and headache or dizziness. Abdominal pain was reported.  Patient appeared older than stated age, acutely and chronically ill and was in no acute distress at the time of report. Cardiovascular examination showed: Regular rate and rhythm without murmur gallop or rub. No edema present in the lower extremities. Radial pulses intact 2 plus bilaterally. Respiratory examination showed: Lungs were clear to auscultation bilaterally no wheezing no rhonchi no rales. No accessory muscle uses no respiratory distress. Patient was currently on room air. Gastrointestinal examination showed: The patient refused an abdominal examination. Abdomen appeared distended. Psychiatric examination: Patient responded appropriately to questions and displayed flat affect. His responses were short and appeared to have good judgment. It was reported that the patient experienced hepatic cancer, hepatic cirrhosis, siderotic hepatic nodule hepatitis c, thrombocytopenia, hyperbilirubinaemia, intestinal ischaemia, ascites, sepsis, small intestinal obstruction, bradycardia, peritonitis bacterial, gastrointestinal oedema, nephrolithiasis, drug abuse, abdominal discomfort, abdominal distension, abdominal pain, alcohol abuse, anticoagulant therapy, arteriosclerosis, auscultation, blood pressure increased, covid-19 (sars-cov-2 test was positive), cholelithiasis, constipation, coronary artery disease, essential hypertension, flatulence, gynaecomastia, hepatic mass, hyponatraemia, hypophagia, infusion, liver disorder, malnutrition, normocytic anaemia, osteoarthritis, pain, pleural effusion, splenomegaly, substance use, tobacco abuse, varices oesophageal, vomiting and nausea. Laboratory data included: Blood pressure increased, Computerised tomogram thorax abnormal, Inflammatory marker test unknown.  Severe sepsis due to spontaneous bacterial peritonitis. Possible underlying enteritis due to COVID-19 infection vs transient bowel ischemia secondary to methamphetamine use vs bowel wall edema from 3rd spacing leading to SBP. COVID-19 infection without hypoxia. Abdominal pain with Constipation possible ileus. Hepatitis C not previously treated. Essential hypertension unknown control. Normocytic anemia uncertain chronicity. Suspected chronic liver disease, coronary artery disease, Right sided pleural effusion, Hyperbilirubinemia Indirect, Osteoarthritis, Elevated transaminases (now improving). Thrombocytopenia (which was now improving).  Mild protein calorie malnutrition. Marijuana use, methamphetamine use, chronic tobacco abuse. Patient had been somewhat bradycardic. The physician discussed that without treatment patient will have the risk of developing hepatic failure and hepatocellular carcinoma. Physician continued to trend his inflammatory markers.  On an unspecified date in JUL-2022, Laboratory data included: Computerised tomogram Abdomen - Abnormal, Moderate ascites, Splenomegaly, Esophageal varices, Abdominal atherosclerosis, and Cirrhosis of the liver was seen with nodules appreciated malignancy vs regeneration secondary to alcohol abuse vs hepatitis c - Cholelithiasis, Nephrolithiasis, and Gynecomastia was seen. Computerised tomogram thorax was abnormal.  On 01-AUG-2022 04:30, Laboratory data included: Blood pressure 136/89, Body temperature 97.9, Heart rate 58, Oxygen saturation 99, and Respiratory rate 16. On 01-AUG-2022 05:05, Laboratory data included: AST/ALT ratio AST/ALT 1.1, Alanine aminotransferase increased, Anion gap 13.6, Aspartate aminotransferase increased, Basophil count decreased, Basophil percentage decreased, Bilirubin conjugated increased (TBILI 1.3 DBILI 0.4), Blood albumin 2.0 (decreased), Blood alkaline phosphatase 79 (normal), Blood bilirubin 1.3 (increased), Blood calcium 7.4 (decreased), Blood chloride 100 (normal), Blood creatinine 0.8 (normal), Blood glucose 124 (normal), Blood osmolarity 272.1 (decreased), Blood potassium 4.5 (normal), Blood sodium 132 (decreased), Blood urea 30 (increased), Blood urea nitrogen/creatinine ratio BUN/CRE 37.5, Carbon dioxide 22.9 (decreased), Creatinine renal clearance unknown, Eosinophil count normal, Eosinophil percentage 1.5, Glomerular filtration rate 99 (normal), Granulocyte percentage not provided, Haematocrit 41.3 (decreased), Haemoglobin 14.3 (normal), Immature granulocyte count unknown, Lymphocyte count normal, Lymphocyte percentage 10 (decreased), Mean cell haemoglobin normal, Mean cell haemoglobin concentration normal, Mean cell volume 86.2 (normal), Mean platelet volume 10. 4 (normal), Monocyte count increased, Monocyte percentage 8.0, Neutrophil count increased, Neutrophil percentage 78.2 (increased), Platelet count decreased, Protein total 6.3 (decreased), Red blood cell count normal, Red cell distribution width increased, Transaminases increased, and White blood cell count increased. On 01-AUG-2022 06:46, Laboratory data included: Blood pressure 160/86, Body temperature 97.8, Heart rate 53, Oxygen saturation 100, and Respiratory rate 16. Laboratory data (dates unspecified) included: Cardiovascular examination Regular rate and rhythm without murmur gallop or rub, Pain scale 7-10, and Physical Examination Patient appeared older than stated age acutely and chronically ill.  Treatment medications (dates unspecified) included: labetalol hydrochloride, ondansetron hydrochloride, hydromorphone hydrochloride, guaifenesin, gabapentin, acetylsalicylic acid, famotidine, promethazine hydrochloride, ceftriaxone, spironolactone, sodium chloride, dexamethasone, propranolol hydrochloride, tramadol hydrochloride, amlodipine besilate, benzonatate, furosemide, enoxaparin, docusate sodium, loratadine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aspartate aminotransferase increased, sepsis, and thrombocytopenia, and the outcome of ast alt ratio, abdominal discomfort, abdominal distension, abdominal pain, alanine aminotransferase increased, alcohol abuse, anion gap, anticoagulant therapy, arteriosclerosis, ascites, auscultation, basophil count decreased, basophil percentage decreased, bilirubin conjugated increased, blood albumin decreased, blood alkaline phosphatase normal, blood bilirubin increased, blood calcium decreased, blood chloride normal, blood creatinine normal, blood glucose normal, blood osmolarity decreased, blood potassium normal, blood pressure increased, blood sodium decreased, blood urea increased, blood urea nitrogen creatinine ratio, bradycardia, covid-19, carbon dioxide decreased, cholelithiasis, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, constipation, coronary artery disease, creatinine renal clearance, drug abuse, eosinophil count normal, eosinophil percentage, essential hypertension, flatulence, gastrointestinal oedema, glomerular filtration rate normal, granulocyte percentage, gynaecomastia, haematocrit decreased, haemoglobin normal, hepatic cancer, hepatic cirrhosis, hepatic mass, hepatitis c, hyperbilirubinaemia, hyponatraemia, hypophagia, immature granulocyte count, inflammatory marker test, infusion, intestinal ischaemia, laboratory test, liver disorder, lymphocyte count normal, lymphocyte percentage decreased, malnutrition, mean cell haemoglobin concentration normal, mean cell haemoglobin normal, mean cell volume normal, mean platelet volume normal, monocyte count increased, monocyte percentage, nausea, nephrolithiasis, neutrophil count increased, neutrophil percentage increased, normocytic anaemia, nucleated red cells, osteoarthritis, pain, peritonitis bacterial, platelet count decreased, pleural effusion, protein total decreased, red blood cell count normal, red cell distribution width, red cell distribution width increased, regenerative siderotic hepatic nodule, sars-cov-2 test positive, small intestinal obstruction, splenomegaly, substance use, tobacco abuse, transaminases increased, varices oesophageal, vomiting and white blood cell count increased was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint (PQC): 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 Vigilance department on 18-AUG-2022. The following information was updated and incorporated into the case narrative: PQC result added.; Sender's Comments: V1:PQC result added Peritonitis bacterial,Sepsis,Small intestinal obstruction,Nephrolithiasis,Cholelithiasis,Gastrointestinal oedema,Intestinal ischaemia,Abdominal discomfort,Abdominal distension,Abdominal pain,Nausea,Vomiting,Pain,Flatulence,Constipation,Pulmonary effusion,Bradycardia,Anticoagulant therapy,Arteriosclerosis,Auscultation,Basophil count decreased,Basophil percentage decreased,Hyponatraemia,Blood Ca decreased,Blood Na decreased,Blood osmolarity decreased,BUNcreatinine ratio,Covid-19,CO2decreased,Anion gap,CTabdomen abnormal,CTthorax abnormal,Creatinine renal clearance,Eosinophil percentage,Granulocyte percentage,Immature granulocyte count,Inflammatory marker,infusion,Lymphocyte percentage decreased,Monocyte count increased,Monocyte percentage,Neutrophil count increased,Neutrophil percentage increased,Nucleated red cells,Sars-cov-2 test positive,WBCcount increased-events have a compatible/suggestive temporal relationship,is unlabeled,and has unknown scientific plausibility.There is no information on any other factors potentially associated with the events.Therefore,this event is considered unassessable  Essential hypertension,BP increased,Coronary artery disease,Osteoarthritis,Drug abuse,Substance use,Tobacco abuse,Hepatic cancer,Hepatic mass,Hepatitis c,Liver disorder,Hepatic cirrhosis,Regenerative siderotic hepatic nodule,Alcohol abuse,Ascites,Gynaecomastia,Thrombocytopenia,Malnutrition,Splenomegaly,Normocytic anaemia,HCTdecreased,RDWincreased,Transaminases increased,Varices oesophageal,ALTincreased,ASTincreased,Hyperbilirubinaemia,Hypophagia,Bilirubin conjugated increased,Blood Alb decreased,Platelet count decreased,Protein total decreased,Blood bilirubin increased,Blood urea increased-events have a compatible/suggestive temporal relationship,is unlabeled,and has unknown scientific plausibility.There are other factors more likely to be associated with the events than the drug.Specifically:MEDICAL HISTORY.Therefore,this event is considered not related