主题：全球（除中国外）新冠确诊死亡数字猜想 -- 须弥一芥

机器翻译一下，有不准确的，参看原版英文。

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接受者和照料者情况说明书

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

紧急使用授权书

EMERGENCY USE AUTHORIZATION (EUA) OF

PFIZER-BIONTECH COVID-19疫苗预防冠状病毒

THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS

疾病2019（COVID-19）

DISEASE 2019 (COVID-19)

16岁及以上的个人

IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

我们将向您提供辉瑞生物技术公司的COVID-19疫苗，以预防由SARS-CoV-2引起的2019年冠状病毒病（COVID-19）。本说明书包含的信息有助于您了解辉瑞BioNTech COVID-19疫苗的风险和益处，您可能会收到该疫苗，因为目前存在COVID-19大流行。

You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.

辉瑞生物技术公司的COVID-19疫苗是一种疫苗，可能会阻止你获得COVID-19。目前还没有美国食品和药物管理局（FDA）批准的疫苗来预防COVID-19。

The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.

有关辉瑞BioNTech COVID-19疫苗的信息，请阅读本说明书。

Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.

如果有问题，请与疫苗接种提供者联系。您可以选择接受辉瑞BioNTech COVID-19疫苗。

Talk to the vaccination provider if you have questions. It is your choice to receive the Pfizer-BioNTech COVID-19 Vaccine.

辉瑞生物技术公司（Pfizer BioNTech）的COVID-19疫苗分两个剂量系列注射到肌肉中，间隔3周。

The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle.

辉瑞生物技术公司的COVID-19疫苗可能不能保护所有人。

The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

本说明书可能已更新。有关最新的情况介绍，请参阅

This Fact Sheet may have been updated. For the most recent Fact Sheet, please see

www.cvdvaccine.com.

在接种疫苗之前你需要知道什么

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

什么是COVID-19？

WHAT IS COVID-19?

COVID-19疾病是由一种名为SARS-CoV-2的冠状病毒引起的。这种冠状病毒以前从未见过。你可以通过与另一个感染病毒的人接触获得COVID-19。它主要是一种呼吸系统疾病，可影响其他器官。据报道，COVID-19患者有多种症状，从轻微症状到严重白细胞增多。症状可能在接触病毒后2至14天出现。症状可能包括：发烧或感冒；咳嗽；呼吸急促；疲劳；肌肉或身体疼痛；头痛；新的味觉或嗅觉丧失；喉咙痛；充血或流鼻涕；恶心或呕吐；腹泻。

COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory il ness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe il ness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chil s; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

什么是PFIZER-BIONTECH COVID-19疫苗？

WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?

辉瑞生物技术公司的COVID-19疫苗是一种未经批准的疫苗，可以预防COVID-19。目前还没有FDA批准的疫苗来预防COVID-19。

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

FDA已经授权辉瑞BioNTech COVID-19疫苗在紧急使用授权（EUA）下紧急使用，以防止16岁及以上的人感染COVID-19。

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).

有关EUA的更多信息，请参阅“什么是紧急使用授权（EUA）”本说明书结尾部分。

For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" section at the end of this Fact Sheet.

在接种疫苗之前，你应该向你的接种者提到什么

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE

你接种了辉瑞生物技术公司的COVID-19疫苗？

YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?

告诉疫苗接种提供者您的所有医疗状况，包括您是否：

Tell the vaccination provider about all of your medical conditions, including if you:

*有过敏症吗

* have any allergies

*发烧

* have a fever

*有出血障碍或正在使用血液稀释剂

* have a bleeding disorder or are on a blood thinner

*免疫功能受损或服用影响免疫系统的药物

* are immunocompromised or are on a medicine that affects your immune system

*怀孕或计划怀孕

* are pregnant or plan to become pregnant

*你在哺乳吗

* are breastfeeding

*已经接种了另一种COVID-19疫苗

* have received another COVID-19 vaccine

谁应该接种PFIZER-BIONTECH COVID-19疫苗？

WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?

FDA已经批准在16岁及以上的人群中紧急使用辉瑞BioNTech COVID-19疫苗。

FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.

谁不应该接种PFIZER-BIONTECH COVID-19疫苗？

WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?

如果您：

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:

*以前注射过这种疫苗后有严重的过敏反应

* had a severe allergic reaction after a previous dose of this vaccine

*对这种疫苗的任何成分都有严重的过敏反应。

* had a severe allergic reaction to any ingredient of this vaccine.

PFIZER-BIONTECH COVID-19疫苗的成分是什么？

WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?

Pfizer BioNTech COVID-19疫苗包括以下成分：mRNA、脂质（（4-羟基丁基）氮杂二烯基）双（己烷-6,1-二基）双（2-癸酸己酯）、2[（聚乙二醇）-2000]-N，N-二乙基乙酰胺、1,2-二硬脂酰-sn-甘油-3-磷酸胆碱和胆固醇）、氯化钾、磷酸二氢钾、氯化钠，二水磷酸二氢钠和蔗糖。

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

PFIZER-BIONTECH COVID-19疫苗是如何注射的？

HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?

Pfizer BioNTech COVID-19疫苗将作为肌肉注射给您。

The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle.

辉瑞BioNTech COVID-19疫苗接种系列为2剂，间隔3周接种。

The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart.

如果您接受一剂辉瑞生物技术公司的COVID-19疫苗，您应该在3周后接受第二剂同样的疫苗，以完成疫苗系列。

If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.

辉瑞生物技术公司的COVID-19疫苗以前使用过吗？

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?

辉瑞生物技术公司的COVID-19疫苗是一种未经批准的疫苗。在临床试验中，约有20000名16岁及以上的患者至少接种了一剂辉瑞生物技术公司的COVID-19疫苗。

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.

PFIZER-BIONTECH COVID-19疫苗有什么好处？

WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

在一项正在进行的临床试验中，辉瑞生物技术公司（Pfizer BioNTech）的COVID-19疫苗在间隔3周注射2剂后，已被证明可以预防COVID-19。对COVID-19的保护持续时间目前尚不清楚。

In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.

PFIZER-BIONTECH COVID-19疫苗有哪些风险？

WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

据报道，辉瑞BioNTech COVID-19疫苗的副作用包括：

Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:

*注射部位疼痛

* injection site pain

*疲倦

* tiredness

*头痛

* headache

*肌肉疼痛

* muscle pain

*寒战

* chills

*关节痛

* joint pain

*发烧

* fever

*注射部位肿胀

* injection site swelling

*注射部位发红

* injection site redness

*恶心

* nausea

*感觉不舒服

* feeling unwell

*淋巴结肿大（淋巴结病）

* swollen lymph nodes (lymphadenopathy)

辉瑞生物技术公司的COVID-19疫苗引起严重过敏反应的可能性很小。一个严重的过敏反应通常会发生在几分钟到一个小时后，获得一剂辉瑞BioNTech冠状病毒-19疫苗。因此，您的疫苗接种提供者可能会要求您留在您接种疫苗的地方，以便在接种疫苗后进行监测。严重过敏反应的症状包括：

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

*呼吸困难

* Dif iculty breathing

*你的脸和喉咙肿胀

* Swelling of your face and throat

*心跳加快

* A fast heartbeat

*全身长满了严重的皮疹

* A bad rash all over your body

*头晕无力

* Dizziness and weakness

这些可能并不是辉瑞生物技术公司（Pfizer BioNTech）COVID-19疫苗可能产生的所有副作用。可能出现严重和意外的副作用。辉瑞生物技术公司的COVID-19疫苗仍在进行临床试验研究。

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is stil being studied in clinical trials.

副作用怎么办？

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

如果你有严重的过敏反应，打9-1-1，或者去最近的医院。

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

如果您有任何副作用困扰您或不想消失，请致电疫苗接种提供者或您的医疗保健提供者。

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

完成并向VAERS在线提交报告https://vaers.hhs.gov/reportevent.html。有关向VAERS报告的更多帮助，请致电1-800-822-7967。请在报告表第18栏第一行填写“辉瑞生物技术公司COVID-19疫苗EUA”。

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. Please include "Pfizer-BioNTech COVID-19 Vaccine EUA" in the first line of box #18 of the report form.

此外，您可以通过以下联系方式向辉瑞公司报告副作用。

In addition, you can report side effects to Pfizer Inc. at the contact information provided below.

网站

Website

www.pfizersafetyreporting.com

传真号码

Fax number

1-866-635-8337

电话号码

Telephone number

1-800-438-1985

您还可以选择注册v-safe。V-safe是一个新的基于智能手机的自愿工具，它使用短信和网络调查来检查接种过疫苗的人，以确定COVID-19疫苗接种后的潜在副作用。V-safe提出的问题有助于CDC监测COVID-19疫苗的安全性。如果需要，V-safe还提供第二次剂量提醒，如果参与者报告COVID-19疫苗接种后对健康有重大影响，CDC也会进行现场电话随访。有关如何注册的更多信息，请访问：www.cdc.gov/vsafe。

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

如果我决定不接种PFIZER-BIONTECH COVID-19疫苗呢？

WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?

您可以选择是否接种辉瑞BioNTech COVID-19疫苗。

It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine.

如果你决定不接受它，它不会改变你的标准医疗保健。

Should you decide not to receive it, it wil not change your standard medical care.

除了PFIZER-BIONTECH-COVID-19疫苗之外，还有其他预防COVID-19的选择吗？

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES PFIZER-BIONTECH COVID-19 VACCINE?

目前，还没有经批准的替代疫苗可用于预防COVID-19。

Currently, there is no approved alternative vaccine available for prevention of COVID-19.

其他预防COVID-19的疫苗可在紧急使用授权下提供。

Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

我可以接受辉瑞生物技术公司的COVID-19疫苗和其他疫苗吗？

CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER VACCINES?

目前还没有关于辉瑞生物技术公司COVID-19疫苗与其他疫苗联合使用的信息。

There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

如果我怀孕或哺乳呢？

WHAT IF I AM PREGNANT OR BREASTFEEDING?

如果你怀孕或哺乳，与你的医疗保健提供者讨论你的选择。

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

辉瑞生物技术公司的COVID-19疫苗会给我COVID-19吗？

WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?

否。辉瑞生物技术公司的COVID-19疫苗不含SARS-CoV-2，不能给你提供COVID-19。

No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

留着你的接种卡

KEEP YOUR VACCINATION CARD

当你第一次注射时，你会得到一张疫苗接种卡，告诉你什么时候再注射第二剂辉瑞生物技术公司的COVID-19疫苗。回来时记得带上你的卡。

When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring your card when you return.