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FDA 对 COVID-19 疫苗的安全监测: 可能造成不良事件后果的工作清单草案
§ 吉兰-巴雷综合征
急性播散性脑脊髓炎
§ 横贯性脊髓炎
脑炎/脊髓炎/脑脊髓炎/
脑膜脑炎/脑膜炎/脑病
抽搐/癫痫发作
中风
发作性睡病和猝倒症
过敏反应
急性心肌梗塞
心肌炎/心包炎
§ 自身免疫性疾病
死亡
怀孕和分娩结果
其他急性脱髓鞘疾病
非过敏性过敏反应
§ 血小板减少症
弥散性血管内凝血
§ 静脉血栓栓塞
关节炎和关节痛/关节痛
§ 儿童川崎病
儿童多系统炎症综合征
疫苗强化疾病
FDA Safety Surveillance of COVID-19 Vaccines :
DRAFT Working list of possible adverse event outcomes
Guillain-Barré syndrome Acute disseminated encephalomyelitis Transverse myelitis Encephalitis/myelitis/ encephalomyelitis/ meningoencephalitis/meningitis/ encepholapathy Convulsions/seizures Stroke Narcolepsy and cataplexy Anaphylaxis Acute myocardial infarction Myocarditis/pericarditis Autoimmune disease Deaths Pregnancy and birth outcomes Other acute demyelinating diseases Non-anaphylactic allergic reactions Thrombocytopenia Disseminated intravascular coagulation Venous thromboembolism Arthritis and arthralgia/joint pain Kawasaki disease Multisystem Inflammatory Syndrome in Children Vaccine enhanced disease
https://www.fda.gov/media/143557/download
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