Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Laboratory test abnormal, Leukocytosis, Limb injury, Lung opacity
Clinical narrative: ACUTE KIDNEY INJURY; ATRIAL FIBRILLATION; CEREBRAL ATROPHY; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; CHRONIC KIDNEY DISEASE; DIABETES MELLITUS INADEQUATE CONTROL; DRUG USE DISORDER; HYPOKALAEMIA; MAJOR DEPRESSION; RENAL IMPAIRMENT; MYOCARDITIS; ACUTE SINUSITIS; ALANINE AMINOTRANSFERASE INCREASED; ANION GAP; ANXIETY; ASPARTATE AMINOTRANSFERASE INCREASED; BEREAVEMENT; BLOOD ALBUMIN DECREASED; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BICARBONATE DECREASED; BLOOD BILIRUBIN NORMAL; BLOOD CALCIUM NORMAL; BLOOD CHLORIDE NORMAL; BLOOD CREATININE INCREASED; BLOOD GLUCOSE NORMAL; BLOOD POTASSIUM NORMAL; BLOOD PRESSURE DECREASED; BLOOD SODIUM DECREASED; BLOOD UREA INCREASED; C-REACTIVE PROTEIN INCREASED; CONFIRMED COVID-19 INFECTION; CHEST X-RAY ABNORMAL; CHRONIC SINUSITIS; COMPUTERISED TOMOGRAM HEAD ABNORMAL; CONDITION AGGRAVATED; CONSTIPATION; CONTUSION; COUGH; CREATININE RENAL CLEARANCE DECREASED; DEPRESSION; DIZZINESS; DYSPNOEA; FALL; FIBRIN D DIMER NORMAL; FULL BLOOD COUNT; GLOMERULAR FILTRATION RATE DECREASED; GLYCOSYLATED HAEMOGLOBIN INCREASED; GOUT; GRIEF REACTION; HEAD INJURY; HYPONATRAEMIA; LABORATORY TEST ABNORMAL; LEUKOCYTOSIS; LIMB INJURY; LUNG OPACITY; METABOLIC FUNCTION TEST; PAIN; PROCALCITONIN NORMAL; PROTEIN TOTAL NORMAL; SARS-COV-2 TEST POSITIVE; SLEEP DISORDER; TREMOR; WHEEZING; WHITE BLOOD CELL COUNT INCREASED; ARTHRALGIA; PAIN IN EXTREMITY; ASTHENIA; HEADACHE; NAUSEA; VOMITING; This spontaneous report received from a health care professional by a Regulatory Authority vaccine adverse event reporting system (VAERS) (VAERS ID 2014223) concerned a 70 year old male of an unspecified race and ethnic origin. The patient's height was 1.683 cm and weight was 99 kilogram. The patient's past medical history included: acute cystitis without hematuria, cardiac arrest with ventricular fibrillation, chronic back pain and biventricular implantable cardioverter-defibrillator (ICD) in place, and concurrent conditions included: penicillin v allergy, dilaudid allergy, hyperlipidemia, acute gout of right elbow, grief reaction depression, anxiety, coronary artery disease, cardiomyopathy, chronic kidney disease, controlled type 2 diabetes mellitus without complication, essential hypertension benign heart disease, chest pain, morbid obesity, myocarditis, Non-ST elevated myocardial infarction (NSTMI), paroxysmal atrial fibrillation, pericardial effusion, polymyalgia rheumatica, pneumonia due to organism severe sepsis, sleep apnea, opioid use, myopericarditis, finger amputation no complication, shortness of breath, longstanding persistent atrial fibrillation, shortness of breath, mild nonproliferative diabetic retinopathy of both eyes without macular edema associated with type 2 diabetes mellitus, statin intolerance, and osteoarthrosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286 expiry: unknown) dose was not reported, administered on 12-MAY-2021 for an unspecified indication. Concomitant medications included diphenhydramine, doxylamine succinate, allopurinol, apixaban, clopidogrel bisulfate, atorvastatin calcium and Acetaminophen (paracetamol) for unknown indication.  On 03-JAN-2022, the patient admitted at Hospital Emergency Department with generalized weakness for 1 week. His wife passed away on holiday from sepsis and he has gradually been declining since. They were able to postpone her funeral so he did not miss it. In the ER patient tested positive for COVID although he was fully vaccinated. He noted that since the last 2 weeks he has had uncontrollable shaking and weakness. He denied fever or chills. He has had some coughing but mild and occasionally felt shortness of breath (SOB) but stated that is due to congestive heart failure and prior cardiac arrest. He denied chest pain palpitations or tachycardia. He stated he had chest pain the day his wife passed and took nitro to take care of the pain but denied pain since. He noted that his wife did not have COVID and he was unaware of any sick contacts. He stated after he had the vaccine he had myocarditis. He denied edema. He has had some falls frequently and noted he fell on the day of hospitalization and day before hospitalization. He fell 3 or 4 times. He noted that he injured his left pinky. He did hit his head day before hospitalization it did not hurt anymore. He was uncertain if he passed out when he fell He noted that he fell walking to his room and stated he told his daughter that he can't stand up and next thing he knew was he was on the floor. He denied facial droop slurred speech confusion or unilateral weakness but has noticed generalized weakness. He had body aches. He noted that his wife's funeral was on Thursday and he wanted to go but HCP told him that since he was COVID positive even if he was feeling better he should not go to the funeral and encouraged patient and daughter that they reschedule the funeral if able. He was then admitted for observation of COVID and weakness. On 03-JAN-2022, the patient experienced acute kidney injury, atrial fibrillation, cerebral atrophy, cerebral small vessel ischemic disease, chronic kidney disease, diabetes mellitus inadequate control, drug use disorder, major depression, myocarditis, renal impairment, acute sinusitis, anxiety, confirmed covid-19 infection, chronic sinusitis, condition aggravated, constipation, contusion, cough, dizziness, dyspnea, fall, gout, grief reaction, head injury, leukocytosis, limb injury, lung opacity, pain, SARS-CoV-2 test positive , sleep disorder, tremor, wheezing, arthralgia, pain in extremity, asthenia, headache, nausea, vomiting. He had several tests over there like: Alanine aminotransferase (NR: 10 - 40) with result 44 IU/L, Anion gap (NR: 9 - 18) with result 16 mmol/L, Aspartate aminotransferase (NR: 10 - 40) with result 38 IU/L, Blood albumin (NR: 35 - 50) with result 27 g/dL, Blood alkaline phosphatase (NR: 40 - 129) with result 92 IU/L, Blood bicarbonate (NR: 21 - 29) with result 20 mmol/L, Blood bilirubin (NR: 2 - 10) with result 4 mg/dL, Blood calcium (NR: 86 - 104) with result 95 mg/dL, Blood chloride (NR: 98 - 112) with result 99 mmol/L, Blood creatinine (NR: 60 - 130) with result 151 dL, Blood glucose (NR: 70 - 99) with result 115 mg/dL, Blood potassium (NR: 34 - 50) with result 38 mmol/L, Blood pressure (NR: not provided) Decrease, Blood sodium (NR: 134 - 146) with result 135 mmol/L, Blood urea (NR: 8 - 20) with result 41 mg/dL, C-reactive protein (NR: not provided) Increased, Chest X-ray which result was Abnormal (showed mildly increased hazy opacity of the left lung base which could represent developing infiltrate versus low inspiratory volumes. No focal consolidation), Computerized tomogram head which result was Abnormal (Mild atrophy, Mild moderate white matter disease and some smaller areas of volume loss likely chronic small vessel ischemic changes, Negative for acute intracranial process No acute traumatic findings status post fall, Mild acute and or chronic right sphenoid sinusitis), Creatinine renal clearance (NR: not provided) Deceased, depression, Fibrin D dimer (NR: not provided) was Normal, Full blood count (NR: not provided) Unknown, Glomerular filtration rate (NR: not provided) Decreased, Glycosylated hemoglobin (NR: not provided) Increased, Laboratory test (NR: not provided) Abnormal, Procalcitonin (NR: not provided) Normal (so likely not bacterial), Protein total (NR: 60 - 80) with result 66 g/dL, SARS-CoV-2 test (NR: not provided) Positive, and White blood cell count (NR: not provided) Increased. He was started on spironolactone 25 mg daily and Imdur was cut to 30 mg daily due to lower BP. His metolazone was held due to his acute kidney injury (AKI). He was discharged on Lasix and aldactone and metolazone was stopped. His sodium and potassium normalized and his renal function was improved. His blood pressures were stable on day of discharge. Atrial fibrillation (A Fib) was well controlled continued on his home CD implantable cardioverter-defibrillator in place. He had history of PAF bradycardia and Mobitz I, Controlled type 2 diabetes mellitus without complication with long-term current use of insulin assessment Plan was Normally on 70 30 30 units three times a day, placed on 36 units of lantus and moderate corrective insulin Continue to monitor blood sugar and adjust insulin as needed. Essential hypertension with goal blood pressure less than 130 85 assessment Plan was Metoprolol. Stopped Metolazone and lasix. Continued to monitor blood pressure, CAD coronary artery disease and ischemic cardiomyopathy sp CAGBx5 assessment Plan was ICD in placed and Continued metoprolol, Plavix, statin and Eliquis. Stopped lasix and metolazone due to AKI he could resume when able Continue Imdur. His weakness was felt to be due to his COVID. He was then admitted for observation of COVID and weakness. He was then on room air Review of Systems Constitutional: Positive for appetite change decreased he did eat some soup, chills and fatigue negative for fever, Negative for congestion rhinorrhea and sore throat, Eyes: Negative for visual disturbance, Respiratory: Positive for cough and shortness of breath, Negative for wheezing and chest tightness, Cardiovascular: Negative for chest pain palpitations and leg swelling, Gastrointestinal: Positive for nausea vomiting just a little bit that morning and constipation. Negative for abdominal pain, diarrhea and blood in stool Genito urinary: Negative for difficulty urinating dysuria and hematuria. Musculoskeletal: Positive for falls body aches all over, Neurological: Positive for headaches dizziness and weakness, Psychiatric Behavioral: Positive for depression wife recently died and sleep disturbance, Skin: Negative for rash Bruises all over Pinched left pinky in hall closet and had wound from that He denied other opened sores. Blood Pressure was 151/77, Pulse was 81, Temperature was 37 °C Oral, Resp was 18, SpO2 was 100% and BMI was 36 88 kg m² Objective. Physical Exam Vitals reviewed Constitutional: General: He was not in acute distress Appearance: He was well-developed. He was obese, He was ill-appearing Comments: Appeared fatigued laying on stretcher in the hall in the ER, Head: Normocephalic and atraumatic, Nose : Nose normal, Mouth Throat: Mouth: Mucous membranes were moist, Pharynx: Oropharynx was clear Eyes: General: Right eye: No discharge Left eye: No discharge Conjunctiva sclera: Conjunctivae normal Neck: Thyroid: No thyromegaly, Vascular: No JV D, Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm Heart sounds: No murmur heard Comments: No lower extremity edema Pulmonary: Effort: No tachypnea or respiratory distress, Breath sounds: Normal breath sounds No wheezing rhonchi or rales Comments: Lungs were fairly clear no wheezing or rhonchi, Abdominal: General: Bowel sounds are normal There is no distension Palpations: Abdomen is soft Tenderness: There is no abdominal tenderness, Musculoskeletal: General: No tenderness Normal range of motion, Cervical back: Normal range of motion and neck supple Right lower leg: No edema Left lower leg: No edema Comments: Equal grip strength and plantar flexion bilaterally but generalized weakness noted Skin: General: Skin was warm and dry Findings: No rash Comments: Abrasion to left pink bandage in place Neurological: Mental Status: He was alert and oriented to person place and time Mental status was at baseline, Cranial Nerves: No cranial nerve deficit Comments: No facial droop slurred speech confusion or unilateral weakness No pronator drift Psychiatric: Speech: Speech normal Behavior: Behavior normal Judgment: Judgment normal Comments: Pleasant but slightly depressed. PT OT recommended skilled nursing facility where he was transferred on 07-JAN-2022 to Facility. Case management had his facility ensured cost of insulin prior to leaving SAR He was needed prior authorization for the corrective insulin. Recommend that he had repeat BMP on 10-JAN-2022 to check renal function and potassium with recent medication changes. Patient was clinically improved and hemodynamically stable for discharge. He noted that he was feeling the best he had in the last few days. HCP discussed plan of care for discharge with patient including outpatient follow-up with PCP within 7 days. Patient voiced understanding and was agreeable with plan of care for discharge Consults: None Procedures: None. He then discharged on 07-JAN-2022. The number of days hospitalized was 4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute kidney injury, acute sinusitis, alanine aminotransferase increased, anion gap, anxiety, arthralgia, aspartate aminotransferase increased, asthenia, atrial fibrillation, bereavement, blood albumin decreased, blood alkaline phosphatase normal, blood bicarbonate decreased, blood bilirubin normal, blood calcium normal, blood chloride normal, blood creatinine increased, blood glucose normal, blood potassium normal, blood pressure decreased, blood sodium decreased, blood urea increased, c-reactive protein increased, confirmed covid-19 infection, cerebral atrophy, cerebral small vessel ischemic disease, chest x-ray abnormal, chronic kidney disease, chronic sinusitis, computerized tomogram head abnormal, condition aggravated, constipation, contusion, cough, creatinine renal clearance decreased, depression, diabetes mellitus inadequate control, dizziness, drug use disorder, dyspnea, fall, fibrin d dimer normal, full blood count, glomerular filtration rate decreased, glycosylated hemoglobin increased, gout, grief reaction, head injury, headache, hypokalemia, hyponatremia, laboratory test abnormal, leukocytosis, limb injury, lung opacity, major depression, metabolic function test, myocarditis, nausea, pain, pain in extremity, procalcitonin normal, protein total normal, renal impairment, confirmed clinical vaccination failure, sleep disorder, tremor, vomiting, wheezing, and white blood cell count increased. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.  Version created to amend previously reported information on 21-JAN-2022.Upon review following information was amended: Event onset date added for event depression.; Sender's Comments: V1:information is onset date for depression. :20220141678-Covid-19 vaccine ad26.cov2.s-Acute kidney injury,Atrial fibrillation,Chronic kidney disease,Blood creatinine increased,Diabetes mellitus inadequate control,Drug use disorder,Anxiety,Major depression,Renal impairment,Myocarditis, Blood urea increased,Cough,Creatinine renal clearance decreased,Dyspnoea,Depression,GFR decreased,Glycosylated haemoglobin increased,Gout,Hyponatraemia. Event is considered not related.Event has compatible/suggestive temporal relationship,is unlabeled & has unknown scientific plausibility.There are other factors more likely to be associated with event than drug.Specifically:MEDICAL HISTORY,UNDERLYING DISEASE 20220141678-Covid-19 vaccine ad26.cov2.s-Cerebral atrophy,Cerebral small vessel ischaemic disease,Hypokalaemia,Acute sinusitis,Alanine aminotransferase increased,Anion gap,Aspartate aminotransferase increased,Bereavement,Blood albumin decreased,Blood alkaline phosphatase normal,Blood bicarbonate decreased,Blood bilirubin normal,Blood calcium normal,Blood chloride normal,Blood glucose normal,Blood potassium normal,Blood pressure decreased,Blood sodium decreased, CRP increased, CONFIRMED COVID-19 INFECTION,Chest X-ray abnormal,Chronic sinusitis,Computerised tomogram head abnormal,Condition aggravated,Constipation,Contusion,Dizziness,Fall,Fibrin D dimer normal,Full blood count,Grief reaction,Head injury,Laboratory test abnormal,Leukocytosis,Limb injury,Lung opacity,Metabolic function test,Pain,Procalcitonin normal,Protein total normal,SARS-CoV-2 test positive,Sleep disorder,Tremor,Wheezing,White blood cell count increased.Event is considered unassessable.Event has compatible/suggestive temporal relationship,is unlabeled,& has unknwn scientifc plausibilty.There is no information on any other factor potentialy asscited with event 20220141678-Covid-19 vaccine ad26.cov2.sArthralgia,Painiextremity,Asthenia,Headache,Nausea,Vomiting.Event is labeled per RSI, considered potentially related; Reported Cause(s) of Death: DEATH FROM SEPSIS