新型冠状病毒疫苗接种知情同意书
【疾病介绍】
新型冠状病毒肺炎（新冠肺炎，COVID-19）为新发急性呼吸道传染病。临床主要表现是发热、干咳、乏力，少数患者伴有鼻塞、流涕、咽痛、 结膜炎、肌痛和腹泻等症状。多数患者预后良好，少数患者病情危重。随着疫情的蔓延，对全球公众健康构成严重威胁。根据当前新冠肺炎防控需要，为适龄人群开展新型冠状病毒疫苗接种。
【疫苗介绍】
当前获批了附条件上市或者获准了紧急使用的苗有三种灭活疫苗、一种腺病毒载体疫苗、一种重组蛋白疫苗。
【疫苗作用】
接种新型冠状病毒疫苗可刺激机体产生抗新型冠状病毒的免疫力，用于预防新型冠状病毒引起的疾病。
【接种禁忌】
疫苗接种禁忌参照产品说明书。通常接种疫苗的禁忌包括：（1）对疫苗或疫苗成分过敏者；（2）患急性疾病者；（3）处于慢性疾病的急性发作期者；（4）正在发热者；（5）妊娠期妇女。
【不良反应】
接种疫苗后发生局部不良反应以接种部位疼痛为主，还包括局部瘙痒、肿胀、硬结和红晕等，全身不良反应以疲劳乏力为主，还包括发热、肌肉痛、头痛、咳嗽、腹泻、恶心、厌食和过敏等（具体详见疫苗说明书）。
如经调查诊断或鉴定，结论为异常反应或不能排除，可按程序进行相关补偿。
【注意事项】
1、接种后留观30分钟，无任何不适方可离开接种现场。
2、未按照疫苗说明书程序完成接种者，建议尽早接种。免疫程序无需重新开始，补种完成相应剂次即可。
3、现阶段暂不推荐加强免疫。暂不推荐与其他疫苗同时接种。
4、现阶段建议用同一个疫苗产品完成接种。如遇疫苗无法继续供应、受种者异地接种等特殊情况，无法用同一个疫苗产品完成接种时，可以采用相同种类的其他生产企业的疫苗产品完成接种。
5、在疫苗接种前无需开展新冠病毒核酸及抗体检测；接种后也不建议常规检测抗体作为免疫成功与否的依据。
6、如接种后出现不适应及时就医，并报告接种单位。
7、与其他疫苗一样，接种本疫苗可能无法对所有受种者产生100%的保护效果。
受种者姓名： 性别： 出生日期： 年 月 日
以下问题可以帮助受种者本次是否可以接种本疫苗。如果对任何问题的回答为 “是”，并不表示受种者不应接种本疫苗，而只是表示还需要询问其他问题。如果对有些问题不清楚，可要求医务人员说明。请您在相应栏目上进行选择（用打“√”表示），并在签名处签字确认。
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健康状况 |
是或否 |
备注 |
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1、近几天有发热、腹泻等不舒服吗？ |
是□ |
否□ |
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2、是否对食物、药物等过敏？ |
是□ |
否□ |
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3、是否对疫苗成分过敏或者曾经在接种疫苗后出现过严重反应？ |
是□ |
否□ |
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4、是否有癫痫、惊厥、脑病或其他神经系统疾病？ |
是□ |
否□ |
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5、是否患有癌症、白血病、艾滋病或其他免疫系统疾病？ |
是□ |
否□ |
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6、在过去三个月内，是否使用过可的松、强的松、其他类固醇或抗肿瘤药物，或进行过放射性治疗？ |
是□ |
否□ |
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7、有哮喘、肛周脓肿、肠套叠、肺部疾病、心脏疾病、肾脏疾病、代谢性疾病（如糖尿病）或血液系统疾病吗？ |
是□ |
否□ |
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8、在过去一年内，是否接受过输血或血液制品或使用过免疫球蛋白？ |
是□ |
否□ |
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9、在过去一个月内是否接种过减毒活疫苗？ |
是□ |
否□ |
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10、是否怀孕或有可能3个月内怀孕？（仅问育龄妇女） |
是□ |
否□ |
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11、其他： |
是□ |
否□ |
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医学建议：1.建议接种□；2.推迟接种□；3.不宜接种□。
对不宜接种者，具体建议
医疗卫生人员签名： 日期： 年 月 日
本人或受种者监护人已接受健康询问，同意医学建议。
受种者/监护人签名： 日期： 年 月 日
监护人与受种者的关系：○母亲 ○父亲 ○其他(请注明)________
Informed Consent for Vaccination in Novel Coronavirus
[Introduction to diseases]
Novel coronavirus (COVID-19, covid-19) is a new acute respiratory infectious disease.
The main clinical manifestations are fever, dry cough and fatigue, and a few patients are accompanied by nasal congestion, runny nose, sore throat, conjunctivitis, myalgia and diarrhea. Most patients have a good prognosis, while a few patients are in critical condition. With the spread of the epidemic, it poses a serious threat to the global public health.
According to the current needs of prevention and control in Covid-19, novel coronavirus vaccination should be carried out for the age-appropriate population.
[Introduction to Vaccine]
At present, there are three kinds of inactivated vaccines, one kind of adenovirus vector vaccine and one kind of recombinant protein vaccine which have been approved for conditional marketing or emergency use.
[Vaccine effect]
Vaccination with novel coronavirus vaccine can stimulate the body's immunity against novel coronavirus, and can be used to prevent diseases caused by novel coronavirus.
[Vaccination contraindications]
Vaccination contraindications refer to product specifications. Usually, the taboos of vaccination include: (1) those who are allergic to vaccines or vaccine components; (2) Patients suffering from acute diseases; (3) Those who are in the acute stage of chronic diseases; (4) Those who are heating up; (5) Pregnant women.
[Adverse reactions]
The local adverse reactions after vaccination mainly include local itching, swelling, induration and blush, while the systemic adverse reactions mainly include fever, muscle pain, headache, cough, diarrhea, nausea, anorexia and allergy (see the vaccine manual for details).
In case of abnormal reaction after investigation, diagnosis or identification, or can not be ruled out, relevant compensation can be made according to the procedure.
[Precautions]
1. Stay under observation for 30 minutes after inoculation, and leave the inoculation site without any discomfort.
2. Those who fail to complete vaccination according to the vaccine instructions are advised to get vaccinated as soon as possible. The immunization program does not need to be restarted, and the corresponding dose can be replanted.
3. Strengthening immunization is not recommended at this stage. Concurrent vaccination with other vaccines is not recommended for the time being.
4. At this stage, it is suggested to complete vaccination with the same vaccine product. In case of special circumstances, such as the vaccine can not be supplied continuously, and the recipients cannot be vaccinated in different places, the vaccine products of other manufacturers of the same kind can be used to complete the vaccination.
5. There is no need to carry out Covid-19 nucleic acid and antibody detection before vaccination; Routine detection of antibodies after vaccination is not recommended as the basis for successful immunization.
6. Such as vaccination does not adapt to the timely medical treatment, and report the vaccination unit.
7. Like other vaccines, vaccination with this vaccine may not produce 100% protective effect on all recipients.
Name of the recipient: gender: date of birth: YY MM DD
The following questions can help the recipients whether they can be vaccinated this time. If the answer to any question is "Yes", it does not mean that the recipient should not be vaccinated, but only that other questions need to be asked. If some problems are unclear, you can ask the medical staff to explain. Please make a selection on the corresponding column (marked with "√"), and sign at the signature place for confirmation.
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state of health |
Yes |
or no |
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remarks |
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1. Do you feel uncomfortable with fever and diarrhea in recent days? |
Yes |
□ |
No |
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2. Are you allergic to food and drugs? |
Yes |
□ |
No |
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3. Are you allergic to vaccine ingredients or have you ever had a serious reaction after vaccination? |
Yes |
□ |
No |
□ |
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4. Is there epilepsy, convulsion, encephalopathy or other nervous system diseases? |
Yes |
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No |
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5. Do you have cancer, leukemia, AIDS or other immune system diseases? |
Yes |
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No |
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6. In the past three months, have you ever used cortisone, prednisone, other steroids or anti-tumor drugs, or received radiotherapy? |
Yes |
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No |
□ |
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7. Do you have asthma, perianal abscess, intussusception, lung disease, heart disease, kidney disease, metabolic disease (such as diabetes) or blood system disease? |
Yes |
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No |
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8. Have you received blood transfusion or blood products or used immunoglobulin in the past year? |
Yes |
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No |
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9. Have you been vaccinated with live attenuated vaccine in the past month? |
Yes |
□ |
No |
□ |
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10. Are you pregnant or may be pregnant within 3 months? (only ask women of childbearing age) |
Yes |
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No |
□ |
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11. Others: |
Yes |
□ |
No |
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Medical advice: 1. Suggest vaccination□ ; 2. Delaying vaccination□;
3. Not suitable for inoculation □.
Specific recommendations for those who are not suitable for vaccination
Signature of medical and health personnel: Date: YY MM DD
I or the guardian of the recipient has accepted the health inquiry and agreed to the medical advice.
Signature of the recipient/guardian: Date: YY MM DD
Relationship between guardian and recipient: ○ mother ○ father ○ other (please specify) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _