Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Mental status changes, NIH stroke scale score increased, Neurological examination abnormal, Perfusion brain scan normal
Clinical narrative: AORTIC VALVE INCOMPETENCE; CEREBRAL ISCHEMIA (SUBSUMED APHASIA, CEREBROVASCULAR ACCIDENT, GAZE PALSY, HEMIPARESIS, MENTAL STATUS CHANGE, WHITE MATTER LESION); VERTEBRAL ARTERY STENOSIS; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1126402) an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fish allergy, milk allergy, codeine allergy, penicillin allergy, dementia, parkinsons, asthma, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: unknown) route of administration, dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included gabapentin 100 mg BID, levothyroxine 100 mcg daily, mirtazapine 15 mg daily, rivastigmine 3 mg TID, montelukast 10 mg daily, pimavanserin 44 mg daily, vortioxetine 5 mg daily, magnesium oxide 250 mg daily, multivitamin 1. On 22-MAR-2021, patient experienced aortic valve incompetence, aphasia, cerebral ischaemia, cerebrovascular accident, gaze palsy, hemiparesis, mental status changes, vertebral artery stenosis, and white matter lesion. It was reported that patient developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was administered 65 mg intravenous piggyback alteplase on 22-MAR-2021 at 12:45 with last known well 10:00. Patient was usual state of health prior to stroke with no illnesses. It was reported that angiogram cerebral abnormal, arteriogram carotid was normal, echocardiogram abnormal, magnetic resonance imaging head abnormal, neurological examination abnormal, perfusion brain scan normal, and stroke scale score increased. On 22-Mar-2021, Brain CT was negative for hemorrhage. On 22-Mar-2021, Brain CT showed apparent decreased cerebral blood flow and volume along the left parietal region, expected location of the posterior branch of the left middle cerebral artery. On 22-Mar-2021, neck CT showed no stenosis in the carotid arteries, severe stenosis of the proximal right vertebral artery. On 22-Mar-2021, CT of perfusion cerebral was negative. On 22-Mar-2021, MRI of brain without contrast showed punctate diffusion signal intensity within the right frontal periventricular white matter. No corresponding adc focus. This could represent t2 shine through of chronic white matter disease or a very small focus of ischemia. Correlate with neurologic assessment. Otherwise there was age compatible chronic microvascular change without additional site of potential acute disease. On 23-Mar-2021, an echocardiogram showed systolic function normal with ef 55-60%, moderate aortic valve regurgitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aortic valve incompetence, cerebral ischemia (subsumed aphasia, cerebrovascular accident, gaze palsy, hemiparesis, mental status change, white matter lesion), vertebral artery stenosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage). This case is duplicate of 20210442034.  Additional information was received from on 06-MAY-2021. It was determined that Manufacturer Report Number [20210442034] was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Report Number [20210437169]. Upon review, the following information was amended: Patient race, ethinicity.; Sender's Comments: V1: Information updated in this version includes patient's race and ethnicity. This information doesn't change the causality of previously reported events. V0:  This 82-year-old female of unspecified ethnicity was found to have aortic valve incompetence, cerebral ischemia, and vertebral artery stenosis 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.   The patient has concurrent food and drug allergies, dementia, Parkinson's, asthma, and hypothyroidism; with concomitant medications of gabapentin, levothyroxine, mirtazapine, rivastigmine, montelukast, pimavanserin, vortioxetine, magnesium oxide.  It was reported that the patient developed altered mental status, right sided weakness, right sided gaze, aphasia.  Cerebral angiogram showed decreased cerebral blood flow and volume along the left parietal region and severe stenosis of the proximal right vertebral artery; brain CT scan was negative for hemorrhage; echocardiogram showed systolic function normal with EF 55-60%, moderate aortic valve regurgitation.  No other laboratory/diagnostic tests reported.  No other details reported.  The short latency, the abnormal cardiac function, and the advance age of the patient confounded the event.  The events are considered not related.