Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Computerised tomogram head abnormal, Computerised tomogram thorax normal, Confusional state, Cough
Clinical narrative: CAROTID ARTERY OCCLUSION; CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; METABOLIC ENCEPHALOPATHY; THALAMIC INFARCTION; HAEMATURIA; COGNITIVE DISORDER; CONFUSIONAL STATE; MUSCULAR WEAKNESS; ECHOCARDIOGRAM NORMAL; URINE ANALYSIS ABNORMAL; ANGIOGRAM CEREBRAL ABNORMAL; BLOOD URINE PRESENT; COMPUTERISED TOMOGRAM HEAD ABNORMAL; COMPUTERISED TOMOGRAM THORAX NORMAL; SARS-COV-2 TEST POSITIVE; ANGIOGRAM PULMONARY NORMAL; ULTRASOUND DOPPLER NORMAL; ASTHENIA; COUGH; DECREASED APPETITE; COVID-19; CEREBROVASCULAR ACCIDENT; ACUTE RESPIRATORY FAILURE; ATRIAL FIBRILLATION; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2572152); concerned a 92 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer, bladder cancer, and hypertension. On 2019, Laboratory data included: Urine analysis not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacture) (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date for an unspecified indication. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacture). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-NOV-2021 for an unspecified indication. Age at time of vaccination 92 years old. No concomitant medications were reported.   On 2021, Laboratory data included: Computerised tomogram which showed bladder mass.  On 26-DEC-2022, the patient experienced weakness (asthenia), cough, poor appetite (decreased appetite) on date of admission and found to have Covid-19, respiratory failure (acute), hypoxia and possible acute CVA (cerebrovascular accident), acute hypoxic respiratory failure (dose number in series 2) and was hospitalized. The patient was hospitalized for 12 days. In setting of COVID-19 Requiring 2L NC, on admission CTPA (Computed tomographic pulmonary angiography) negative for PE (pulmonary embolism) (angiogram pulmonary normal) and No deep vein thrombosis on ultrasound dopplers (normal), Antitussive/mucolytic, prn albuterol, mobilize. On 2-3L NC, wean as tolerated; may need some more time to wean as SNF (sic) pulmonary followed covid-19 virus infection. On 28-DEC-2022, patient had CT of chest (computerised tomogram thorax) which showed no infiltrate (normal) and was tested positive for covid-19 (sars-cov-2 test positive) (dose number in series 2). Oxygen requirements on admission was 2L, Current oxygen requirements was 2L, Medical therapy included remdesivir completed, continued dexamethasone. Consultants following: pulmonary. Anticipated special isolation end date was 06-JAN-2023. On an unspecified date in 2023, patient had confusion (confusional state), slight L (left) arm weakness (muscular weakness), subacute right thalmic stroke (thalamic infarction), likely small vessel disease (cerebral small vessel ischaemic disease). Patient had CTH (computed tomography head) which showed indeterminant infarct R thalamus (abnormal), CTA (Computed Tomography Angiography) (angiogram cerebral abnormal) showed chronic right-ICA (internal carotid artery) occlusion at the level of skull base with distal reconstitution at the cavernous segment, Neurology signed off PT/OT/SLP. Patient had Atrial fibrillation with RVR (rapid ventricular rate), spontaneously converted to NSR (Normal sinus rhythm). Started on low dose Lopressor, had TTE (transthoracic echocardiogram) which was unremarkable. Will need eliquis but had significant hematuria with bladder cancer. Patient had acute metabolic encephalopathy, cognitive (cognitive disorder), decline Aox1 on arrival, family reports suspicion of early dementia not diagnosed, worse confusion in recent days. (dose number in series 2) PTA (Percutaneous transluminal angioplasty) Due to COVID positive, CVA contribution Delirium precautions; Otherwise as above alert to self, Added trazadone for sleep at night, gross hematuria bladder mass. Urine analysis (UA) showed large blood (abnormal) (blood urine present). Patient followed with an outside urologist doctor and had consistently expressed he did not want this treated further. Monitor for gross hematuria with addition of antiplatelet, urology consult if needed.  Treatment medications (dates unspecified) included: acetylsalicylic acid, apixaban, trazodone, salbutamol, oxygen, remdesivir, metoprolol tartrate, and dexamethasone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute respiratory failure, angiogram cerebral abnormal, angiogram pulmonary normal, asthenia, atrial fibrillation, blood urine present, covid-19, carotid artery occlusion, cerebral small vessel ischaemic disease, cerebrovascular accident, cognitive disorder, computerised tomogram head abnormal, computerised tomogram thorax normal, confusional state, cough, decreased appetite, echocardiogram normal, haematuria, metabolic encephalopathy, muscular weakness, sars-cov-2 test positive, thalamic infarction, ultrasound doppler normal and urine analysis abnormal was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed.  Additional information was received from Complaint department on 17-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up adds information about  Product quality complaint investigation result. This does not alter previous causality assessment of the reported events.   20230228510- Atrial Fibrillation, Carotid Artery Occlusion, Cerebral Small Vessel Ischaemic Disease, Cerebrovascular Accident, Metabolic Encephalopathy, Thalamic Infarction, Haematuria,  Cognitive Disorder, Confusional State,  Decreased Appetite, Muscular Weakness, Urine Analysis Abnormal, Angiogram Cerebral Abnormal, Blood Urine Present, Computerised Tomogram Head Abnormal, Asthenia. The Event Shows An Incompatible Temporal Relationship. Therefore, This Event Is Considered Inconsistent With Vaccine Administration.  20230228510-Acute Respiratory Failure, Covid-19, Sars-Cov-2 Test Positive, Cough,. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.   20230228510-Echocardiogram Normal, Ultrasound Doppler Normal, Angiogram Pulmonary Normal, Computerised Tomogram Thorax Normal. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.