SUSPECTED CLINICAL VACCINATION FAILURE; COMPUTERISED TOMOGRAM ABDOMEN; ECHOCARDIOGRAM; NORMOCYTIC ANAEMIA; PLATELET COUNT NORMAL; CONDITION AGGRAVATED; DYSPHAGIA; DYSURIA; HAEMATURIA; FEEDING DISORDER; LUNG OPACITY; OEDEMA PERIPHERAL; PLEURAL EFFUSION; URINARY TRACT INFECTION; CONFUSIONAL STATE; VOMITING; NAUSEA; PROTEINURIA; ANISOCYTOSIS; CULTURE URINE POSITIVE; HAEMOGLOBIN DECREASED; HYPOMAGNESAEMIA; LEFT VENTRICULAR END-DIASTOLIC PRESSURE; LEFT VENTRICULAR END-DIASTOLIC PRESSURE INCREASED; LYMPHOCYTE COUNT DECREASED; LYMPHOPENIA; PULMONARY ARTERIAL PRESSURE ABNORMAL; RED BLOOD CELL SCHISTOCYTES; ULTRASOUND DOPPLER ABNORMAL; WHITE BLOOD CELL COUNT DECREASED; BLOOD CREATININE INCREASED; BLADDER CATHETERISATION; DEEP VEIN THROMBOSIS; THROMBOCYTOPENIA; ANTICOAGULANT THERAPY; ACUTE KIDNEY INJURY; CARDIAC FAILURE; CHRONIC KIDNEY DISEASE; URINARY RETENTION; TRICUSPID VALVE INCOMPETENCE; MITRAL VALVE INCOMPETENCE; TOXIC ENCEPHALOPATHY; HEMIPARESIS; HYPOXIA; LEUKOPENIA; PNEUMONIA KLEBSIELLA; COVID-19 PNEUMONIA; COVID-19; This spontaneous report received from a health care professional via a Regulatory Authority  [ reference number 1689665] concerned a 75 year old female (historian) of unknown race and ethnicity. Initial information was processed along with the additional information received from on 29-SEP-2021. The patient's height, and weight were not reported. The patient's past medical history included: stroke/cerebrovascular accident (was in rehabilitation), mastectomy, thyroidectomy (was admitted to hospital from 24th July to 6th August, year unspecified) and had poor oral intake, nauseous, intermittent emesis while in the rehabilitation, frequent urinary tract infection, and concurrent conditions included: anxiety disorder unspecified, breast cancer, chronic kidney disease, disease of thyroid gland, essential primary hypertension, gastroesophageal reflux disease, hearing loss, hyperlipidemia, major depressive disorder, obesity, polyneuropathy unspecified, peripheral neuropathy, thyroid nodule, type 2 diabetes mellitus without complications, osteoarthritis, arthritis, right sided weakness, diabetic nephropathy, and t12 compression fracture. The patient had no known drug allergies (NKDA) and was in rehabilitation. The patient was recently discharged from hospital with concern to urinary retention and urinary tract infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-APR-2021 for an unspecified indication. The drug start period was 132 days. Concomitant medications included thiamine for delerium precaution, venlafaxine hydrochloride for depression and anxiety, carvedilol for hypertension, isosorbide dinitrate for hypertension, nifedipine for hypertension, insulin (basal bolus while inpatient), and Tradjenta (resume at home) for type 2 diabetes mellitus, acetylsalicylic acid (aspirin), atorvastatin, linagliptin, calcium carbonate, cholecalciferol, cyanocobalamin, lidocaine, macrogol 3350 (miralax), ondansetron, and paracetamol (Tylenol).  On 25-JUL-2021, Laboratory data included: HbA1C (NR: not provided) 8.5 percent. On 26-JUL-2021, Laboratory data included: Iron analysis (NR: not provided) suggestive of anemia of chronic disease (AOCD). On 18-AUG-2021, the patient was presented to Emergency Department concerned for toxic encephalopathy, hypoxia to 85 percent in triage which required nasal cannula (NC), dysuria and urinary retention. The patient was found to be covid positive and was hospitalized on 18-AUG-2021 at 05:20 pm.  The patient experienced deep vein thrombosis, thrombocytopenia, acute hypoxic respiratory failure likely covid-19 pneumonia, chronic bilateral pleural effusions right greater than left, acute kidney injury, cardiac failure/heart failure with midrange ejection fraction (HFmREF), chronic kidney disease, urine analysis showed proteinuria, pyuria and hematuria, confusional state regarding which the family in the room has been concerned, and reported that the patient was more confused recently, urinary tract infection, tricuspid valve incompetence, anisocytosis, anticoagulant therapy, condition aggravated, dysphagia, feeding disorder, haemoglobin decreased, hemiparesis, hypomagnesaemia, left ventricular end-diastolic pressure increased, leukopenia, lung opacity, lymphocyte count decreased, lymphopenia, mitral valve incompetence, normocytic anaemia, oedema peripheral, pleural effusion, pneumonia Klebsiella pulmonary arterial pressure abnormal, red blood cell schistocytes, ultrasound doppler abnormal, urinary retention and was bladder catheterization multiple times a day with Foley's insertion, vomiting and nausea. Laboratory data included: Blood creatinine (NR: not provided) increased, Chest X-ray (NR: not provided) Bilateral effusions right greater than left, creatinine (NR: not provided) 1.53, Culture urine (NR: not provided) positive, echocardiogram (NR: not provided) not reported, Hemoglobin (NR: not provided) 9.3 (unit unspecified), decreased, Lymphocyte count (NR: not provided) decreased, 0.68 (unit unspecified), NT-proBNP (N-terminal pro brain-type natriuretic peptide) (NR: not provided) 3609, Platelet count (NR: not provided) normal, 155 (unit unspecified), and White blood cell count (NR: not provided) decreased, 3.29 (units unspecified). On 19-AUG-2021, the patient was treated with dexamethasone, and remdesivir for covid-19 for 9 and 4 days respectively. On 20-AUG-2021, Laboratory data included: Magnesium (NR: not provided) 1.4 (unit unspecified). On 21-AUG-2021, Laboratory data included: White blood cell count (NR: not provided) 1.81 (units unspecified). On 23-AUG-2021, the patient had a computerised tomogram abdomen without evidence of hydronephrosis or obstruction, Lymphocyte count (NR: not provided) 0.25 (unit unspecified), NT-proBNP (NR: not provided) 03764, and Transthoracic echocardiogram (TTE) (NR: not provided) Ejection fraction (EF) of 40-50 percentage with mild to moderate mitral regurgitation (MR) and signs of increased Left ventricular end-diastolic pressure (LVEDP) mild Tricuspid regurgitation (TR) with ePASP of 35-50 mm Hg. On 24-AUG-2021, Laboratory data included: Creatinine (NR: not provided) 2.14. On 25-AUG-2021, Laboratory data included: Platelet count (NR: not provided) 128 (unit unspecified). On 26-AUG-2021, Laboratory data included: Magnesium (NR: not provided) 2.0 (unit unspecified). On 01-SEP-2021, Laboratory data included: Chest X-ray (NR: not provided) improved aeration of right effusion and decreased right sided effusion, Hemoglobin (NR: not provided) stable at 8.9 (unit unspecified), Lymphocyte count (NR: not provided) 1.34 (unit unspecified), Platelet count (NR: not provided) 159 (unit unspecified), Urine culture (NR: not provided) growing Klebsiella pneumonia and was planned to Continue Cefdinir for 7 days course, and White blood cell count (NR: not provided) 5.61 (units unspecified). On 03-SEP-2021, Laboratory data included: Creatinine (NR: not provided) 1.60, improved almost back to baseline and Urine protein/creatinine ratio (NR: not provided) 5.0 (unit not reported), suggestive of nephrotic range proteinuria. On an unspecified date, the patient experienced suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Blood smear test (NR: not provided) Leukopenia including neutropenia, Folate (NR: not provided) normal, Vitamin B12 (NR: not provided) normal and Venous Duplex (NR: not provided) negative for deep vein thrombosis. Additional treatment medications (dates unspecified) included: morniflumate (Flomax) which was stopped as there was no evidence of clinical benefit with Flomax for urinary retention in females. The patient was weaned off from nasal cannula and was sitting well at room air since last few days also the mental status was back to baseline. It was reported that there wasn't a need for isolation on discharge given clinical symptomatic improvement and that the patient had no fever for a while as it was greater than 10 days since the patient was tested positive. Per sister, the patient sees urology as outpatient and reportedly had prior issues with urination and that the patient would try voiding trial again prior discharge otherwise would plan to discharge with Foley's with outpatient urology follow up which has an appointment scheduled on 08/SEP/2021. The patient was advised to monitor creatinine as outpatient, repeat protein-creatinine ratio in 1 month, follow up with nephrology as outpatient, to start Lantus 5 U daily and increased dose of Coreg (Carvedilol) 25 BID (bis in die) on discharge. The patient was on mechanical soft diet as per speech-language pathologist (SLP). The physical therapy and occupational Therapy (PT OT) recommended acute rehabilitation but was denied by insurance, hence the patient was discharged to Skilled Nursing Facility (SNF). The patient was discharged on 03-SEP-2021, and duration of hospitalization was 16 days.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep vein thrombosis, thrombocytopenia, covid-19, covid-19 pneumonia, acute kidney injury, cardiac failure, chronic kidney disease, proteinuria, confusional state, toxic encephalopathy, urinary tract infection, tricuspid valve incompetence, anisocytosis, anticoagulant therapy, bladder catheterisation, blood creatinine increased, computerised tomogram abdomen, condition aggravated, culture urine positive, dysphagia, dysuria, echocardiogram, feeding disorder, haematuria, haemoglobin decreased, hemiparesis, hypomagnesaemia, hypoxia, left ventricular end-diastolic pressure, left ventricular end-diastolic pressure increased, leukopenia, lung opacity, lymphocyte count decreased, lymphopenia, mitral valve incompetence, normocytic anaemia, oedema peripheral, platelet count normal, pleural effusion, pneumonia klebsiella, pulmonary arterial pressure abnormal, red blood cell schistocytes, ultrasound doppler abnormal, urinary retention, white blood cell count decreased, vomiting, and nausea, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with a product quality complaint 90000195222. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 05-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:PQC inv result added.This does not alter causality of previously reported events. 20210949528-covid-19 vaccine ad26.cov2.s- acute kidney injury,CKD,Urinary retention,hemiparesis,Dysuria,Hematuria,Edema peripheral,UTI,Vomiting,Nausea, Proteinuria,Culture urine positive,Hb decereased,Hypomagnesemia,blood creatinine increased,Normocytic anemia,bladder catheterization.This event(s) is considered not related.The event(s) has a compatible/suggestive temporal relationship,is unlabeled,&has unknown scientific plausibility.There are other factors more likely to be associated with the event(s) than the drug.Specifically:MEDICAL HISTORY,UNDERLYING DISEASE 20210949528-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship,is unlabeled & has unknown scientific plausibility There are other factors more likely to be associated with the event(s) than the drug.Specifically:SPECIAL SITUATIONS 20210949528-covid-19 vaccine ad26.cov2.s-cardiac failure,tricuspid valve incompetence,mitral valve incompetence,toxic encephalopathy,Hypoxia,Leucopenia, Pneumonia klebsialla,COVID19 pneumonia,COVID19,Condition aggravated,Dysphagia,Feeding disorder,Lung opacity,Pleural effusion,Confusional state, Anicocytosis,left ventricular end-diastolic pressure,left ventricular end-diastolic pressure increase,lympho count decrease,Lymphopenia,pulmonary arterial pressure abnormal,RBC schistocytes, ultrasound doppler abnormal,WBC decrease,CT abdomen,Echocardiogram,PLTcount normal.This events are considered unassessable. The event(s) has compatible/suggestive temporal relationship,is unlabeled,and has unknown scientific plausibility.There is no information on any other factors potentially associated with the event(s) 20210949528-covid-19 vaccine ad26.cov2.s-Deep vein thrombosis,thrombocytopenia, anticoagulant therapy.This event(s) is labeled per RSI & is therefore considered potentially related