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Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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FDA-CBER-2021-5683-0950948
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• are immunocompromised or are on a medicine that affects your 
immune system  
• are pregnant, plan to become pregnant, or are breastfeeding  
• have received another COVID -19 vaccine  
• have ever fainted in association with an injection  
The vaccine may not prote ct everyone.  
 
Side effects reported with the vaccine include:  
• There is a remote chance that the vaccine could cause a severe allergic 
reaction  
o A severe allergic reaction would usually occur within a few 
minutes to one hour after getting a dose of the v accine. For this 
reason, your vaccination provider may ask you to stay at the 
place where you received your vaccine for monitoring after 
vaccination  
o Signs of a severe allergic reaction can include difficulty 
breathing, swelling of your face and throat, a fast heartbeat, a 
bad rash all over your body, dizziness, and weakness  
o If you experience a severe allergic reaction, call 9 -1-1 or go to 
the nearest hospita l 
• Myocarditis (inflammation of the heart muscle) and pericarditis 
(inflammation of the lining outside the heart) have occurred in some 
people who have received the vaccine. In most of these people, 
symptoms began within a few days following receipt of the second 
dose of the vaccine. The chance of having this occur is very low. You 
should seek medical attention right away if you have any of the 
following symptoms after receiving the vaccine:  
o chest pain  
o shortness of breath  
o feelings of having a fast -beating, f luttering, or pounding heart  
• Side effects that have been reported with the vaccine include:  
o severe allergic reactions; non -severe allergic reactions such as 
rash, itching, hives, or swelling of the face; myocarditis 
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immunocompromise  
The Pfizer -BioNTech COVID -19 Vaccine has received EUA from FDA to:  
• prevent COVID -19 in individuals 12 years of age and older, a nd 
• provide a third dose to individuals 12 years of age and older who have 
been determined to have certain kinds of immunocompromise  
The FDA -approved COMIRNATY® (COVID -19 Vaccine, mRNA) and the EUA -
authorized Pfizer -BioNTech COVID -19 Vaccine have the same f ormulation 
and can be used interchangeably to provide the COVID -19 vaccination 
series. An individual may be offered either COMIRNATY® (COVID -19 Vaccine, 
mRNA) or the Pfizer -BioNTech COVID -19 Vaccine to prevent coronavirus 
disease 2019 (COVID -19) caused by SARS -CoV-2. 
The emergency use of the product has not been approved or licensed by 
FDA, but has been authorized by FDA, under an Emergency Use 
Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID -19) for use 
in individuals 12 years of age and olde r; and the emergency use of this 
product is only authorized for the duration of the declaration that 
circumstances exist justifying the authorization of emergency use of the 
medical product under Section 564(b)(1) of the FD&C Act unless the 
declaration is terminated or authorization revoked sooner. For these 
authorized uses, the vaccine has not been approved or licensed.  
Please do not respond to this e -mail. This informational email was sent to 
you in response to your friend’s request. Your personal informa tion has not 
been stored and your e -mail address will not be shared with any third 
parties. You have not been signed up to receive further information. If you 
would like to sign -up, please visit Comirnaty.com . If you would like to get in 
touch with Pfizer, visit the Contact Us  page or call 1-800-879-3477 . 
View the Pfizer Privacy Policy here . 
Pfizer  
P.O. Box 29387  
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