Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Creatinine renal clearance decreased, Depression, Echocardiogram, Echocardiogram abnormal
Clinical narrative: ALANINE AMINOTRANSFERASE INCREASED; ANION GAP NORMAL; BLOOD ALBUMIN DECREASED; BLOOD ALKALINE PHOSPHATASE NORMAL; BLOOD BICARBONATE NORMAL; BLOOD BILIRUBIN NORMAL; BLOOD CALCIUM DECREASED; BLOOD CHLORIDE NORMAL; BLOOD CREATININE NORMAL; BLOOD GLUCOSE INCREASED; BLOOD POTASSIUM NORMAL; BLOOD SODIUM NORMAL; BLOOD UREA NORMAL; ASPARTATE AMINOTRANSFERASE INCREASED; CREATININE RENAL CLEARANCE DECREASED; MEAN CELL HAEMOGLOBIN CONCENTRATION NORMAL; MEAN CELL HAEMOGLOBIN NORMAL; MEAN CELL VOLUME NORMAL; MEAN PLATELET VOLUME INCREASED; METABOLIC FUNCTION TEST; METABOLIC FUNCTION TEST ABNORMAL; FULL BLOOD COUNT ABNORMAL; GLOMERULAR FILTRATION RATE NORMAL; HAEMATOCRIT DECREASED; HAEMOGLOBIN DECREASED; PLATELET COUNT ABNORMAL; PROTEIN TOTAL NORMAL; RED BLOOD CELL COUNT DECREASED; RED BLOOD CELL NUCLEATED MORPHOLOGY; RED CELL DISTRIBUTION WIDTH NORMAL; WHITE BLOOD CELL COUNT DECREASED; HYPOAESTHESIA; SCAN WITH CONTRAST ABNORMAL; SWALLOW STUDY; MAGNETIC RESONANCE IMAGING HEAD NORMAL; NIH STROKE SCALE SCORE INCREASED; NEUROLOGICAL EXAMINATION; ECHOCARDIOGRAM ABNORMAL; ATRIOVENTRICULAR BLOCK FIRST DEGREE; ELECTROCARDIOGRAM PR PROLONGATION; ELECTROCARDIOGRAM QRS COMPLEX; ELECTROCARDIOGRAM QT INTERVAL; ELECTROCARDIOGRAM ABNORMAL; CARDIAC TELEMETRY; COMPUTERISED TOMOGRAM HEAD NORMAL; EXPOSURE TO SARS-COV-2; ANTICOAGULANT THERAPY; DEPRESSION; MUCOSAL HYPERTROPHY; CONDITION AGGRAVATED; ANGIOGRAM CEREBRAL ABNORMAL; CEREBRAL ARTERY STENOSIS; VERTEBRAL ARTERY ARTERIOSCLEROSIS; CAROTID ARTERIOSCLEROSIS; CARDIO-RESPIRATORY ARREST; TRANSIENT ISCHAEMIC ATTACK; BELL'S PALSY; CEREBRAL ATROPHY; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; FACIAL PARALYSIS; TYPE 2 DIABETES MELLITUS; BUNDLE BRANCH BLOCK LEFT; SINUS BRADYCARDIA; WHITE MATTER LESION; CHEST PAIN; COVID-19; CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; ANXIETY; THROMBOCYTOPENIA; EJECTION FRACTION DECREASED; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: watchman left atrial appendage closure device, transient ischemic attack, and motor vehicle accident, and concurrent conditions included: roator cuff tear, ankylosing spondylitis, elevated liver enzymes, post-concussion syndrome, venous insufficiency of both lower extremities, chronic obstructive pulmonary disease, iron deficiency, calcification of abdominal aorta (Without abdominal aortic aneurysm), asthma, morbid obesity with body mass index of 50 or higher, diabetes mellitus type ii, nonischemic cardiomyopathy, left bundle branch block, chronic combined systolic and diastolic congestive heart failure, coronary artery disease with angina pectoris, bell's palsy, obstructive sleep apnea (on CPAP(Continuous positive airway pressure therapy)), hyperlipidemia, fatty liver, hypertension, and strawberry allergy (anaphylaxis and hives). The patient experienced drug allergy and renal failure when treated with sulfa drugs, and drug allergy, nausea and vomiting when treated with morphine, and drug allergy and leg cramps when treated with atorvastatin, and drug allergy and dyspnea when treated with duloxetine hydrochloride, drug allergy and insomnia when treated with dexamethasone, and drug allergy and throat swelling when treated with citalopram hydrobromide. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-JUN-2021 for an unspecified indication. Concomitant medications included acetylsalicylic acid for coronary artery disease, sertraline hydrochloride for depression, venlafaxine hydrochloride for depression, ezetimibe for hyperlipidaemia, rosuvastatin calcium for hyperlipidaemia, heparin for hyperlipidemia, lisinopril for hypertension, metoprolol for hypertension, insulin for type 2 diabetes mellitus, amiodarone hydrochloride, ascorbic acid, colecalciferol, docusate sodium, ferrous sulfate, salbutamol, and warfarin sodium.  On 07-SEP-2021, the patient experienced ejection fraction decreased. Laboratory data included: Echocardiogram (NR: not provided) abnormal, congestive heart failure (CHF): Systolic and diastolic: ejection fraction (EF): 45%. On 12-NOV-2021, the patient experienced thrombocytopenia and chest pain. On the same day, the patient was tested positive for COVID due to family members with COVID symptoms (covid-19, confirmed clinical vaccination failure, sars-cov-2 test positive). He has been very anxious since he tested positive. The patient is fully vaccinated. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 13-NOV-2021 08:21, Laboratory data included: Electrocardiogram (NR: not provided) not reported. On 15-NOV-2021, the patient presented to the emergency department after developing sudden onset of right facial droop (facial paralysis) and right facial numbness and left-sided facial numbness (hypoaesthesia). Someone thought he might have facial weakness but by the time he was seen in the emergency department no facial weakness was noted. Full neurological exam was normal (neurological examination), RA stroke scale was 1 (RA stroke scale score increased), computerised tomography (CT) of the head and magnetic resonance imaging (MRI) brain were negative for stroke (computerised tomogram head normal and magnetic resonance imaging head normal). Symptoms thought to be likely due to his Bell's palsy or anxiety. On the same day, the patient also experienced vertebral artery arteriosclerosis, type 2 diabetes mellitus, transient ischaemic attack, cerebral small vessel ischaemic disease, cerebral atrophy, cerebral artery stenosis, carotid arteriosclerosis, cardio-respiratory arrest, bell's palsy, depression, angiogram cerebral abnormal, exposure to sars-cov-2, anticoagulant therapy, atrioventricular block first degree, bundle branch block left, cardiac telemetry, condition aggravated, echocardiogram abnormal, electrocardiogram PR prolongation, electrocardiogram QRS complex, electrocardiogram QT interval, electrocardiogram abnormal, mucosal hypertrophy, scan with contrast abnormal, sinus bradycardia, swallow study, and white matter lesion. Laboratory data included: Swallow study (NR: not provided) Not reported. On 15-NOV-2021 13:14, Laboratory data included: Computerised tomogram head (NR: not provided) Approximately 50% short segment narrowing of the intracranial right internal carotid artery just above the skull base unchanged since 2020, 2 Approximately 50% atherosclerotic narrowing of the mid portion of the supraclinoid right internal carotid artery also unchanged 3 Severe short segment narrowing of the intracranial left internal carotid artery just above the skull base approximately 80% which is new since the prior exam in 2020 This may be due to age indeterminant dissection atherosclerosis or a combination of these 4 Approximately 50% atherosclerotic narrowing of the supraclinoid left internal carotid artery 5 Approximately 50% short segment atherosclerotic narrowing of the proximal intracranial left vertebral artery (normal); On 15-NOV-2021 13:42, Laboratory data included: Electrocardiogram (NR: not provided) Diagnosis Sinus bradycardia with 1st degree AV block Left bundle branch block (Abnormal). On 15-NOV-2021 18:05, Laboratory data included: Magnetic resonance imaging head (NR: not provided) No acute infarct 2 Chronic findings including intracranial volume loss and mild-to-moderate chronic small vessel ischemic changes (normal). On 16-NOV-2021, the patient experienced anion gap normal, alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, blood alkaline phosphatase normal, blood bicarbonate normal, blood bilirubin normal, blood calcium decreased, blood chloride normal, blood creatinine normal, blood glucose increased, blood potassium normal, blood sodium normal, blood urea normal, creatinine renal clearance decreased, full blood count abnormal, glomerular filtration rate normal, haematocrit decreased, haemoglobin decreased, mean cell haemoglobin concentration normal, mean cell haemoglobin normal, mean cell volume normal, mean platelet volume increased, metabolic function test. On 16-NOV-2021, the patient experienced metabolic function test abnormal, platelet count abnormal, protein total normal, red blood cell count decreased, red blood cell nucleated morphology, red cell distribution width normal, white blood cell count decreased. On 16-NOV-2021 06:26, Laboratory data included: Laboratory data included: Anion gap 10 mmol/L, Alanine aminotransferase 60 IU/L, Alkaline phosphatase 93 IU/L, Aspartate aminotransferase 36 IU/L, Blood albumin 3.2 g/dL, Blood bicarbonate 26 mmol/L, Blood bilirubin 0.6 mg/dL, Blood calcium 8.6 mg/dL, Blood chloride 100 mmol/L, Blood creatinine 0.89 mg/dL, Blood glucose 139 mg/dL, Blood potassium 3.8 mmol/L, Blood sodium 136 mmol/L, Blood urea 12 mg/dL, and Glomerular filtration rate normal. On 16-NOV-2021 12:45, Laboratory data included: Full blood count (NR: not provided) abnormal. On 16-NOV-2021 14:06, Laboratory data included: Haematocrit 36.9 %, Haemoglobin 12.5 g/dL, Mean cell haemoglobin 30.2 pg, Mean cell haemoglobin concentration 33.9 g/dL, Mean cell volume 89.1 fL, Mean platelet volume 12.7 fL, Metabolic function test Abnormal, Platelet count abnormal, Protein total 6.4 g/dL, Red blood cell count 4.14 10*6/uL, Red cell distribution width 12.9 %, and White blood cell count 3.73 10*3/uL. On the same day, the patient was scheduled for rotator cuff repair full tear but was cancelled due to COVID. The patient did receive monoclonal antibody for his COVID infection. The patient was hospitalized for 2 days due to the events (admission and discharge dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertebral artery arteriosclerosis, type 2 diabetes mellitus, transient ischaemic attack, cerebral small vessel ischaemic disease, thrombocytopenia, cerebral atrophy, cerebral artery stenosis, carotid arteriosclerosis, cardio-respiratory arrest, bell's palsy, facial paralysis, chest pain, covid-19, anxiety, depression, alanine aminotransferase increased, angiogram cerebral abnormal, anion gap normal, exposure to sars-cov-2, anticoagulant therapy, aspartate aminotransferase increased, atrioventricular block first degree, blood albumin decreased, blood alkaline phosphatase normal, blood bicarbonate normal, blood bilirubin normal, blood calcium decreased, blood chloride normal, blood creatinine normal, blood glucose increased, blood potassium normal, blood sodium normal, blood urea normal, bundle branch block left, cardiac telemetry, computerised tomogram head normal, condition aggravated, creatinine renal clearance decreased, echocardiogram abnormal, ejection fraction decreased, electrocardiogram PR prolongation, electrocardiogram QRS complex, electrocardiogram QT interval, electrocardiogram abnormal, full blood count abnormal, glomerular filtration rate normal, haematocrit decreased, haemoglobin decreased, hypoaesthesia, magnetic resonance imaging head normal, mean cell haemoglobin concentration normal, mean cell haemoglobin normal, mean cell volume normal, mean platelet volume increased, metabolic function test, metabolic function test abnormal, mucosal hypertrophy, RA stroke scale score increased, neurological examination, platelet count abnormal, protein total normal, red blood cell count decreased, red blood cell nucleated morphology, red cell distribution width normal, sars-cov-2 test positive, scan with contrast abnormal, sinus bradycardia, swallow study, white blood cell count decreased, and white matter lesion, 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: 90000205232. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the RI evaluation/investigation performed.  Additional information received from RA department on 09-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: RA:This version updates RA report, causality retained as in Version 0 . 20211202158-covid19 vaccine-Type2DM,TIA,bell's palsy,block 1st degree,LBBB,ALT increased,AST increased,Alb decreased,blood glucose increased.This event considered not related Event has a compatible/suggestive temporal relationship,unlabeled,unknown scientific plausibility,There are other factors more likely to be associated with event than drug SpecificallyMEDICAL HISTORY Vertebral artery arteriosclerosis,cerebral small vessel ischaemic disease,thrombocytopenia,cerebral artery stenosis,carotid arteriosclerosis,Anxiety,depression,cerebral atrophy,CR arrest,facial paralysis,covid19,chest pain,condition aggravated,mucosal hypertrophy,sars-cov2 positive,sinus bradycardia,angio cerebral abnormal,anion gap normal,exposure to sars-cov2,anticoagulant therapy,ALP normal,HCO3 normal,bili normal,Ca decreased,Cl normal,Cr normal,K normal,Na normal,BU normal,cardiac telemetry,CT head normal,Cr renal clearance decreased,ECG abnormal,EF decreased,PR prolongation,QRS complex,QT interval,FBC abnormal,GFR normal,HCT decreased,HB decreased,MRI head normal,MCHC normal,MCH normal,MCV normal,MPV increased,metabolic function test,metabolic function test abnormal,RA stroke score increased,neurological examination,platelet count abnormal,protein total normal,RBC decreased,RBC nucleated morphology,RDW normal,scan contrast abnormal,swallow study,WBC decreased,white matter lesion.This event considered unassessable,compatible/suggestive temporal relationship,unlabeled,unknown scientific plausibility,There is no information on other factors potentially associated with event Confirmed clinical Vaccination failure.This event is considered not related Event has compatible/suggestive temporal relationship,unlabeled,unknown scientific plausibility There are other factors more likely to be associated with event than drug.Specifically:SPECIAL SITUATIONS Hypoesthesia:This event is labeled per RA is considered potentially related.