Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure, White matter lesion
Clinical narrative: DYSARTHRIA; SOMNOLENCE; HEMIPLEGIA; ISCHAEMIC STROKE; EMBOLIC STROKE; TRANSIENT ISCHAEMIC ATTACK; HYPERCOAGULATION; OROPHARYNGEAL PAIN; RHINORRHOEA; MALAISE; SARS-COV-2 TEST POSITIVE; SPINAL NERVE STIMULATOR IMPLANTATION; LYMPHOCYTE COUNT DECREASED; C-REACTIVE PROTEIN INCREASED; NIH STROKE SCALE; PROCALCITONIN; SERUM FERRITIN; ECHOCARDIOGRAM NORMAL; FIBRIN D DIMER; ENDOTRACHEAL INTUBATION; PNEUMONIA ASPIRATION; INTENSIVE CARE; COMPUTERISED TOMOGRAM HEAD ABNORMAL; FACIAL PARALYSIS; ARTERIOSCLEROSIS CORONARY ARTERY; CEREBELLAR INFARCTION; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; LACUNAR INFARCTION; HYPOVENTILATION; ARTERIOSCLEROSIS; MUCOSAL HYPERTROPHY; WHITE MATTER LESION; COMPUTERISED TOMOGRAM NECK; SCAN WITH CONTRAST; ANGIOGRAM; BLOOD GLUCOSE NORMAL; NEUROLOGICAL EXAMINATION ABNORMAL; COUGH; MOVEMENT DISORDER; EMPHYSEMA; SINUS CONGESTION; PYREXIA; ASTHENIA; ATELECTASIS; SPINAL OSTEOARTHRITIS; RIB FRACTURE; HYPOPERFUSION; COVID-19; CARDIOMEGALY; UNRESPONSIVE TO STIMULI; CONFIRMED CLINICAL VACCINATION FAILURE; CEREBROVASCULAR ACCIDENT; CONDITION AGGRAVATED; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1708967 and 1716357) concerned a 68 year old male. Initial information was processed with the additional information received on 06-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: dysphagia, hip pain, low back pain, pain in limb, pressure injury of right ankle stage 2, pressure injury of sacral region stage 2, COVID-19, and hospital(hospitalization), and concurrent conditions included: essential hypertension benign, chronic obstructive pulmonary disease, acute ischemic stroke, chronic kidney disease stage 3, avoidant personality disorder, schizoaffective disorder, dyslipidemia, arthritis chronic pain disorder, lumbar spondylosis, urinary tract infection, indwelling urethral catheter, penicillin anaphylaxis allergy (throat swelling and was given Antihistamines), generalized weakness, urinary retention, aspiration pneumonia of left lower lobe, peanut/peanut oil allergy, sulfa allergy, and micronized NSAIDs/ NSAID allergy. The patient experienced confusion when treated with duloxetine hydrochloride, and tramadol for drug used for unknown indication, and drug allergy when treated with diphenhydramine, ibuprofen for drug used for unknown indication, and rash when treated with codeine for drug used for unknown indication. Laboratory data included: Glomerular filtration rate (NR: not provided) 30-59 ml min.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A) dose was not reported, 1 total, administered on right arm on 04-JUN-2021 for an unknown indication. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, amlodipine besilate for drug used for unknown indication, ascorbic acid for drug used for unknown indication, atorvastatin calcium for drug used for unknown indication, calcium/colecalciferol for drug used for unknown indication, clozapine for drug used for unknown indication, and paracetamol for drug used for unknown indication. The patient was admitted with aspiration pneumonia left lower lob on 26-AUG-2021 (pneumonia aspiration) and was discharged back to AFC (adult foster care) home and unfortunately required more assistance than they could provide and required 2-3 personal assistant (condition aggravated). On 07-SEP-2021, the patient had COVID symptoms reported. The COVID testing was negative on 08-SEP-2021.The patient was negative two days ago and was fully vaccinated per report. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. On 09-SEP-2021, the patient was presented to emergency room to hospital admission as patient experienced significant weakness (asthenia) for the past couple days. The patient was admitted for evaluation by physical therapy-occupational therapy (PT OT) for recommendations for rehab placement. He had complaints of cough, sinus congestion, nasal drainage (rhinorrhoea), and sore throat (oropharyngeal pain).Patient developed a fever (pyrexia) on presentation as well. The COVID testing was repeated on admission on 09-SEP-2021, which was positive COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive and confirmed clinical vaccination failure), however, he remained stable on room air with plans for monoclonal antibody treatment. The patient had malaise, could not lift right upper or lower extremity (movement disorder). It was reported that the patient had cerebrovascular accident, emphysema, hypoperfusion, hypoventilation, and was unresponsive to stimuli. The patient underwent several laboratory examinations which included blood glucose normal (NR: not provided) 102, blood pressure (NR: not provided) 142/67, Neurological examination (NR: not provided) abnormal, and Chest scan (NR: not provided) which (indicated streaky left basilar opacities favored to represent atelectasis. No new focal airspace opacity. No pneumothorax or pulmonary edema. There was unchanged mild cardiomegaly, chronic bilateral rib fractures. Degenerative changes of the spine are present, intrathecal stimulator lead with tip in the mid thoracic spine (spinal osteoarthritis) and small left pleural effusion was unchanged). On 10-SEP-2021, the patient was hospitalized. The chief complaint reason for admission was Acute ischemic stroke (embolic stroke) status post tissue plasminogen activator (TPA). As per neurology, the patient had acute ischemic stroke status post tissue plasminogen activator, suspect embolic atherosclerosis (arteriosclerosis) versus hypercoagulable state (hypercoagulation) in the setting of COVID plus transient ischemic attack(TIA). On 10-SEP-2021, the patient underwent computerized tomogram angiogram of head with IV contrast stroke which indicated (flow was identified within the basilar artery and proximal PCAs. There was a fetal origin of the right PCA (posterior cerebral artery) and no evidence of stenosis), computerized tomogram angiogram of neck with IV contrast which indicated (aortic arch: conventional three vessel anatomy, moderate calcified plaque, right common and internal carotid arteries: Common carotid artery was patent without significant stenosis. There was moderate largely calcified plaque at the proximal internal carotid artery which produces at least mild and potentially moderate stenosis (arteriosclerosis coronary artery), not definitively flow-limiting, left common and internal carotid arteries: scattered plaque along the common carotid artery course without flow-limiting stenosis. Calcified plaque at the bifurcation and carotid bulb with no evidence of more than mild proximal ICA (internal carotid artery) narrowing, vertebral arteries: Left vertebral artery was developmentally dominant. No more than mild narrowing of the left vertebral artery origin and no evidence of significant right ostial stenosis), computerized tomogram of head without IV contrast which indicated (small chronic infarction in the right cerebellum (Cerebellar infarction) and there appeared an interval new small infarct at the upper left cerebellum (lacunar infarct at left thalamus and small left cerebellar infarct), patchy low attenuation in the periventricular and other supra tentorial white matter compatible (white matter lesion), with at least moderate chronic small vessel ischemic disease (cerebral small vessel ischaemic disease) and probable superimposed tiny chronic lacunar infarctions. Congenital abnormality of the tentorium, calcified atherosclerotic plaque noted and posterior calvarial defect again noted. The orbital contents were intact. There was ethmoidal mucosal thickening (mucosal hypertrophy) and clear mastoid cells. No acute cranial hemorrhage, mass effect, or evidence of large acute territorial infarct) and computerized Tomogram perfusion of brain with IV contrast (No CT perfusion evidence of infarct core or ischemic tissue at risk). The case was discussed with neurologist, and if there were no evidence of acute bleed recommended TPA (tissue plasminogen activator) and if there were no large vessel occlusion, then would plan for transfer to stroke ICU (intensive care unit).  On the evening of 16-SEP-2021, he was last known well (LKW). At 22:30 hours, upon reevaluation he had acute onset right facial droop (facial paralysis), right upper extremity and right lower extremity (RUE and RLE) plegia (hemiplegia) and then dysarthria(was unable to answer questions) at 00:44 hours of 17-SEP-2021. A stroke code was initiated. The blood pressure was 142/67 mmHg. A head computerized tomogram (CT) was negative for acute hemorrhage yet revealed a new acute subacute lacunar infarct at the left thalamus and small left cerebellar infarct (computerised tomogram head abnormal, cerebellar infarction, lacunar infarction). The computed tomography angiography (CTA) was significantly degraded by motion vessels visualized were negative for large vessel occlusion (LVO), Computed Tomography Perfusion (CTP)with no hypoperfusion or core. Accordingly, Tissue plasminogen activator (TPA) was administered at 02:17 and the patient was transferred to Intensive Care Unit (intensive care)for further evaluation. Upon arrival to the ICU, he was drowsy (somnolence) and dysarthric and followed simple commands. His strength appeared generalized and minimally worse on right. The lacunar workup would be completed and his COVID for potential respiratory compromise would be followed. A review of systems (ROS)was difficult secondary to dysarthria. He denied chest pain, abdominal pain and was unable to obtain complaints due to dysarthria.  From 16-SEP-2021, the assessment plan was given as acute ischemic stroke, stable CT head showed acute subacute lacunar infarct at the left thalamus and a small left cerebellar infarction. The tissue plasminogen activator (tPA) given with no complications with some improvement of symptoms. They were unable to perform magnetic resonance imaging (MRI) brain due to implanted low back stimulator (spinal nerve stimulator implantation). Repeat computed tomography head(CTH) had been stable with no evidence of bleed or new infarcts. The echocardiogram (ECHO) was normal. The patient was continued on statin. The physical therapy, occupational therapy (PT OT), speechlanguage pathologist (SLP) consulted and was recommended sub-acute rehab (SAR) and dysphagia diet. The normal BP goal was given. The discharge planned to subacute rehab. The COVID-19 Assessment Plan was given as improving Current oxygen requirement: SpO2: 92 percentage, oxygen flow Rate per minute: 2 liters min, Lymphocyte count: 0.75 (lymphocyte count decreased), C-reactive protein: 28.5 (C-reactive protein increased), fibrin D-dimer and serum ferritin: No results provided, Procalcitonin: 0.07 and dexamethasone 6 mg per day was given. On day 6, the Venous thromboembolism (VTE) prophylaxis with enoxaparin and escalating oxygen support up to and including intubation (endotracheal intubation).  In SEP-2021, Laboratory data included: NIH (National Institutes of Health)stroke scale (NR: not provided) Not reported, Oxygen saturation (NR: not provided) 92 percentage, and Procalcitonin (NR: not provided) 0.07. On 17-SEP-2021, Laboratory data included: Blood pressure (NR: not provided) 142/67 mmHg, CT angiography (NR: not provided) Negative, Angiogram (NR: not provided) no evidence of stenosis Computerised tomogram neck (NR: not provided) without significant stenosis, and Scan with contrast (NR: not provided) no perfusion evidence, no evidence of stenosis, computerised tomogram head (NR: not provided) Abnormal. Treatment medications (dates unspecified) included: dexamethasone and enoxaparin. The number of days hospitalized was reported as 8 days for events transient ischaemic attack, spinal nerve stimulator implantation, serum ferritin, somnolence, pneumonia aspiration, procalcitonin, rhinorrhoea, lymphocyte count decreased, malaise, NIH (National Institutes of Health )stroke scale, hypercoagulation, ischaemic stroke, fibrin D dimer, hemiplegia, echocardiogram normal, embolic stroke, endotracheal intubation, dysarthria and c-reactive protein increased and 11 days of hospitalization was reported for arteriosclerosis, asthenia, covid-19, cerebellar infarction, computerised tomogram head abnormal, condition aggravated, cough, facial paralysis, intensive care, lacunar infarction, oropharyngeal pain sars-cov-2 test positive, angiogram, arteriosclerosis coronary artery, atelectasis, blood glucose normal, cardiomegaly, cerebral small vessel ischaemic disease, cerebrovascular accident, computerised tomogram neck, emphysema, hypoperfusion, hypoventilation, movement disorder, mucosal hypertrophy, neurological examination abnormal, pyrexia, rib fracture, scan with contrast, sinus congestion, spinal osteoarthritis, unresponsive to stimuli and white matter lesion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arteriosclerosis, asthenia, c-reactive protein increased, covid-19, cerebellar infarction, computerised tomogram head abnormal, condition aggravated, cough, dysarthria, echocardiogram normal, embolic stroke, endotracheal intubation, facial paralysis, fibrin d dimer, hemiplegia, hypercoagulation, intensive care, ischaemic stroke, lacunar infarction, lymphocyte count decreased, malaise, NIH (National Institutes of Health)stroke scale, oropharyngeal pain, pneumonia aspiration, procalcitonin, rhinorrhoea, sars-cov-2 test positive, serum ferritin, somnolence, spinal nerve stimulator implantation, and transient ischaemic attack, and the outcome of confirmed clinical vaccination failure, angiogram, arteriosclerosis coronary artery, atelectasis, blood glucose normal, cardiomegaly, cerebral small vessel ischaemic disease, cerebrovascular accident, computerised tomogram neck, emphysema, hypoperfusion, hypoventilation, movement disorder, mucosal hypertrophy, neurological examination abnormal, pyrexia, rib fracture, scan with contrast, sinus congestion, spinal osteoarthritis, unresponsive to stimuli and white matter lesion was not reported. This report was associated with product quality complaint: 90000196324 and 90000197039 This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20211008977.  Additional information was received on 03-NOV-2021. It was determined that Manufacturer Case Number (20211008977) was a duplicate of this case. All relevant information regarding this case(20211008977) will be submitted under Manufacturer Case Number (20211009378).; Sender's Comments: V1: Additional information updated in this version include: It was determined that Manufacturer Case Number (20211008977) was a duplicate of this case. All relevant information regarding this case(20211008977) will be submitted under Manufacturer Case Number (20211009378). This updated information does not alter the causality of previously reported events. 20211009378-covid-19 vaccine ad26.cov2.s -cerebellar infarction, embolic stroke, facial paralysis, hemiplegia, ischaemic stroke, lacunar infarct, transient ischaemic attack, arteriosclerosis, dysarthria. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211009378-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, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211009378-covid-19 vaccine ad26.cov2.s -pneumonia aspiration, COVID-19, Cough, malaise, asthenia, condition aggravated, hypercoagulation, C reactive protein increased, Oropharyngeal pain, Rhinorrhoea, SARS CoV-2 test positive, Serum ferritin, lymphocyte count decreased, Echocardiogram normal, Somnolence, endotracheal intubation, fibrin d dimer, procalcitonin, intensive care, spinal nerve stimulator implantation, NIH stroke scale, computerised tomogram head abnormal. This event(s) is considered unassessable. The event(s) has a 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).