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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