Sex: U
Vaccine: COVID19
Symptoms: Ischaemic stroke, Multiple sclerosis, Multiple sclerosis relapse, Myasthenia gravis, Myelitis
Clinical narrative: ISCHEMIC STROKE; ENCEPHALOPATHY; ENCEPHALITIS; MYELITIS; BRAIN TUMOR; PARKINSON DISEASE; OPTIC NEURITIS; IDIOPATHIC INTRACRANIAL HYPERTENSION; MYASTHENIA GRAVIS; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS FLARES; BELLS PALSY; This solicited report received from a health care professional from literature. This report concerned six patients of an unspecified age, sex, race and ethnicity were enrolled in a non-company sponsored study. The purpose of the study was to monitor for vaccine related adverse events, they prospectively identified patients hospitalized for prespecified neurologic conditions who received mRNA or adenovirus COVID-19 vaccines and assessed cases for potential risk factors and alternative etiologies of the adverse event. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: metabolic derangement, hypertension, diabetes, hyperlipidemia, cardiovascular disease, atrial fibrillation, hypercoagulable state, systemic infection, organ failure, alzheimer disease, parkinson disease, autoimmune encephalitis, hypertensive encephalopathy, lupus encephalitis, mild cognitive impairment, normal pressure hydrocephalus, seizures, wernicke encephalitis, nonalcoholic steatohepatitis, and pneumonitis. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, expiry date and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. They identified prespecified neurologic conditions in hospitalized (date unspecified) individuals within 6 weeks of receipt of a dose of any COVID-19 vaccination between 11-DEC-2020, and 22-JUN-2021. Among 3,830 individuals screened for COVID-19 vaccination status and neurologic conditions, 138 (3.6 percent) cases were included in this study (126 after mRNA and 6 after Janssen vaccines). All 138 cases (100 percent) had 1 or more risk factors and/or evidence for established causes.  In this study, 138 (3.6 percent) of the initially assessed population of 3,830 patients had a diagnosis of a neurologic adverse events of special interest (AESIs). Ischemic stroke (52, 37.7 percent) and encephalopathy (45, 32.6 percent) were the predominant neurologic conditions. There were 5 cases (3.6 percent) of encephalitis, 4 cases (2.9 percent) of multiple sclerosis (MS) 2 new diagnoses and 2 flares (multiple sclerosis flares), 3 cases (2.2 percent) of Bell palsy, 2 cases (1.4 percent) of myelitis, myasthenia gravis (1, 0.7 percent), optic neuritis (1, 0.7 percent), idiopathic intracranial hypertension (1, 0.7 percent), brain tumor (4, 2.9) percent, parkinson disease (1, 0.7 percent). There were 9 patients (6.5 percent) who died during acute hospitalization. Of these, 3 were diagnosed with stroke, 4 with encephalopathy. Fifty-six (43.1 percent) of the 130 patients discharged from hospital were subsequently readmitted within 6 months, and 9 (16.1 percent) of these readmitted patients died during their readmission. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of ischemic stroke and encephalopathy on an unspecified date, and the outcome of encephalitis, multiple sclerosis, bells palsy, myelitis, myasthenia gravis, optic neuritis, brain tumor, idiopathic intracranial hypertension, parkinson disease and multiple sclerosis flares was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and ischemic stroke, encephalopathy, encephalitis, myelitis, brain tumor, parkinson disease, optic neuritis, idiopathic intracranial hypertension, myasthenia gravis, multiple sclerosis, and multiple sclerosis flares was not related, and between covid-19 vaccine ad26.cov2.s, and bells palsy was related.   It was concluded that, the small number of patients vaccinated with Janssen limited our ability to draw conclusions regarding clinically serious neurologic outcomes for this vaccine, however, no unusual or unexpected patterns were observed. In the setting of a pandemic vaccination program, detailed clinical reviews of adverse events may help compliment the findings from more traditional epidemiologic surveillance systems. This study adds to the growing body of evidence that mRNA COVID-19 vaccines are safe for neurologic outcomes. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20231140901-ischemic stroke, encephalopathy, encephalitis, multiple sclerosis, multiple sclerosis flare, myelitis, myasthenia gravis, optic neuritis, brain tumor, idiopathic intracranial hypertension, parkinson disease. The event 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. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE. Therefore, this event is considered inconsistent with vaccine administration. 20231140901-bells palsy. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: STROKE; ENCEPHALOPATHY