Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral small vessel ischaemic disease, Cerebrovascular accident, Chest X-ray, Cognitive disorder, Computerised tomogram
Clinical narrative: ACUTE KIDNEY INJURY; CAROTID ARTERIOSCLEROSIS; CAROTID ARTERY STENOSIS; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; CEREBROVASCULAR ACCIDENT; CONGENITAL CEREBROVASCULAR ANOMALY; ENCEPHALOPATHY; FACIAL BONES FRACTURE; HYPERTENSIVE EMERGENCY; VERTEBRAL ARTERY OCCLUSION; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; BACK PAIN; ATELECTASIS; EXOSTOSIS; CENTRAL VENOUS CATHETERISATION; COGNITIVE DISORDER; EYE HAEMANGIOMA; FALL; GLIOSIS; CONDITION AGGRAVATED; HYPERTENSION; INJURY; HYPERTROPHY; LUNG DISORDER; LYMPH NODE CALCIFICATION; MASS; MENTAL STATUS CHANGES; OSTEOARTHRITIS; PAIN; POSTURE ABNORMAL; SCIATICA; SOFT TISSUE SWELLING; SCOLIOSIS; SPINAL OSTEOARTHRITIS; VERTEBRAL FORAMINAL STENOSIS; VERTEBRAL OSTEOPHYTE; WHITE MATTER LESION; BLOOD CULTURE NEGATIVE; ANGIOGRAM CEREBRAL ABNORMAL; ARTERIOGRAM CAROTID ABNORMAL; ANGIOGRAM NORMAL; PERFUSION BRAIN SCAN NORMAL; COMPUTERISED TOMOGRAM SPINE; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; ELECTROENCEPHALOGRAM ABNORMAL; IMAGING PROCEDURE; INTERVERTEBRAL DISC SPACE NARROWING; MAGNETIC RESONANCE IMAGING; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; MAGNETIC RESONANCE IMAGING NECK; MAGNETIC RESONANCE IMAGING SPINAL ABNORMAL; SARS-COV-2 TEST POSITIVE; SCAN WITH CONTRAST ABNORMAL; This spontaneous report received from a other health professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1889703) concerned a 77 year old female. Initial information was processed along with the additional information received on 02-DEC-2021. The patient's height, and weight were not reported. The patient's past medical history included: diarrhea, decrease in appetite, sleep disturbance, weakness, and frequent falls, and concurrent conditions included: circulatory vertebral artery occlusion left, chronic kidney disease stage 2, benign paroxysmal positional vertigo, pulmonary embolism, hypothyroidism, anxiety, depression, nervous peripheral neuropathy, restless legs syndrome, sciatica, back pain, and etoh abuse. The patient was previously treated with hydralazine for hypertension, nicardipine for hypertension; and experienced agitation when treated with codeine. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total administered on left arm on 18-MAR-2021 for an unspecified indication. Concomitant medications included fosfomycin for chronic kidney disease, amlodipine besilate and Lisinopril for hypertension, acetylsalicylic acid, atorvastatin, atorvastatin calcium, levothyroxine sodium, salbutamol, salbutamol sulfate for unknown indication.  On 10-NOV-2021, the patient fell while walking down the stairs to do laundry. She was referred to emergency room after being found down by her son. She was worked up for the fall with no acute findings on imaging. Her son states that after the fall patient had no facial bruising. She was noted to had an acute kidney injury (AKI) at that time and possible urinary tract infection (UTI) and was given a dose of fosfomycin. Since that fall she was doing fine. She had lot of pain because she was unable to get her usual injection (unspecified) for back pain with sciatica that she normally gets. She was found to be extremely hypertensive and was given hydralazine with no improvement and eventually was started on a nicardipine drip. The head computed tomography (CT) was done to rule out intracerebral brain hemorrhage (ICH) and Computed Tomography Perfusion (CTP) and computed tomography angiography (CTA) of head were done that ruled out ischemic stroke. CTA did show an occlusion of the left cervical vertebral artery of unknown chronicity. She was also found to have an acute kidney injury and be COVID positive. Her pulse oxygen was stable on room air. She was placed on NC due to encephalopathy, Encephalopathy unclear etiology and she had Continuous electroencephalogram (cEEG0 with presence of generalized periodic discharges with triphasic morphology was suggestive of an underlying encephalopathy which was nonspecific but typically seen in the setting of toxic or metabolic dysfunction. The Neck magnetic resonance imaging (MRI) was negative for fracture. The COVID infection did not meet protocol for remdesivir and Decadron The hypertensive emergency was not well controlled. The cardine drip was stopped and started on oral blood pressure medications including Lisinopril Norvasc and Hydrochlorothiazide. On 12-NOV-2021, the patient tested positive for sars-cov (severe acute respiratory syndrome coronavirus)-2 test and experienced confirmed clinical vaccination failure and covid-19, acute kidney injury, carotid arteriosclerosis, carotid artery stenosis, cerebral small vessel ischemic disease, cerebrovascular accident, congenital cerebrovascular anomaly, encephalopathy, facial bones fracture, hypertensive emergency, vertebral artery occlusion, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, blood culture negative, central venous catheterization, cognitive disorder. The following events were also reported computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, electroencephalogram abnormal, exostosis, eye hemangioma, fall, gliosis, hypertension, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion. Patient discharged after inpatient 6 day stay on 18-NOV-2021.  Laboratory data included: Angiogram (NR: not provided) Normal, Angiogram cerebral (NR: not provided) was performed at 17:09 and there is no evidence of intracranial aneurysm or other vascular lesion was found, Arteriogram carotid (NR: not provided) was performed at 18:03 and there is occlusion of the left cervical vertebral artery proximally found, Blood culture (NR: not provided) negative, Computerized tomogram abdomen (NR: not provided) abnormal, Computerized tomogram head (NR: not provided) abnormal, Computerized tomogram thorax (NR: not provided) abnormal, Computerized tomography (NR: not provided) No acute fracture dislocation, Normal, Electroencephalogram (NR: not provided) abnormal, Imaging procedure (NR: not provided) not specified, Magnetic resonance imaging (NR: not provided) not specified, Magnetic resonance imaging head (NR: not provided) abnormal, Magnetic resonance imaging neck (NR: not provided) negative, Magnetic resonance imaging spinal (NR: not provided) abnormal, Perfusion brain scan (NR: not provided) was performed at 17:19 and there is no regional abnormality of relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), Infarct core volume CBF greater than 30percent : 0 mL and Critical hypoperfusion volume Tmax less than 6 sec was found, and Scan with contrast (NR: not provided) abnormal, Magnetic resonance imaging spine cervical with and without contrast performed at 15:14 and no discrete lesion was found in the cervical spinal cord Vertebrae, Magnetic resonance imaging brain with and without contrast performed at 15:06 and had no evidence of acute infarction, Computerized tomography chest, abdomen and pelvis with contrast in which There is no lymph node, heart has a normal size and No contusion Pleural Space. The pancreas is normal Spleen. The stomach and small bowel are normal with no obstruction or inflammation. Computerized tomography interpret spine lumbar with contrast performed at 18:23 Lumbar spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography interpret spine thoracic with contrast at 18:20. Thoracic spine scoliosis and degeneration and no acute fracture dislocation was found. Computerized tomography spine cervical with contrast at 18:16. No acute fracture dislocation was found. Computerized tomography maxillofacial without iv contrast performed 18:07 and there is a nondisplaced acute left nasal bone fracture was found. Single view chest was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute kidney injury, angiogram cerebral abnormal, angiogram normal, arteriogram carotid abnormal, atelectasis, back pain, blood culture negative, carotid arteriosclerosis, carotid artery stenosis, central venous catheterization, cerebral small vessel ischemic disease, cerebrovascular accident, cognitive disorder, computerized tomogram abdomen abnormal, computerized tomogram head abnormal, computerized tomogram spine, computerized tomogram thorax abnormal, condition aggravated, congenital cerebrovascular anomaly, electroencephalogram abnormal, encephalopathy, exostosis, eye haemangioma, facial bones fracture, fall, gliosis, hypertension, hypertensive emergency, hypertrophy, imaging procedure, injury, intervertebral disc space narrowing, lung disorder, lymph node calcification, magnetic resonance imaging, magnetic resonance imaging head abnormal, magnetic resonance imaging neck, magnetic resonance imaging spinal abnormal, mass, mental status changes, osteoarthritis, pain, perfusion brain scan normal, posture abnormal, sars-cov-2 test positive, scan with contrast abnormal, sciatica, scoliosis, soft tissue swelling, spinal osteoarthritis, vertebral artery occlusion, vertebral foraminal stenosis, vertebral osteophyte, white matter lesion, covid-19, confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint: 90000205225 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 21-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This version updates PQC, previous causality assessment retained. 20211201324-Covid-19 vaccine ad26.cov2.s-Acute kidney injury, vertebral artery occlusion, Sciatica. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORYCovid-19 vaccine ad26.cov2.s- Angiogram cerebral abnormal,angiogram normal,arteriogram carotid abnormal,atelectasis,back pain,blood culture negative,carotid arteriosclerosis,carotid artery stenosis, central venous catheterization,cerebral small vessel ischemic disease,cerebrovascular accident, cognitive disorder,CT abdomen abnormal,CT head abnormal,CT spine,CT thorax abnormal,condition aggravated,congenital cerebrovascular anomaly,EEG abnormal,encephalopathy,exostosis, eye haemangioma,facial bones fracture,fall, gliosis,HTN,hypertensive emergency,hypertrophy,imaging procedure,injury,intervertebral disc space narrowing,lung disorder,lymph node calcification,MRI,MRI head abnormal,MRI neck,MRI spinal abnormal,mass,mental status changes,osteoarthritis,pain,perfusion brain scan normal,posture abnormal,sars-cov-2 test positive, scan with contrast abnormal,scoliosis,soft tissue swelling,spinal osteoarthritis,vertebral foraminal stenosis,vertebral osteophyte,white matter lesion,covid-19.This event is considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, have unknown scientific plausibility.There is no information on any other factors potentially associated with the events.Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure.This event is considered not related.The event has a compatible/suggestive temporal relationship,is unlabeled, has unknown scientific plausibility.There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS