The COVID-19 vaccine has been shrouded in a wave of doubt and controversy. For starters, the vaccine has been linked to the deaths of more than 10,000 Americans, more than 40,000 hospitalizations, and at least 600,000 adverse reports. So, what are the “hidden clauses” in the Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine Disclaimer? In this blog, we’ve transcribed the disclaimer for you so that you can understand why this can’t be played on the commercials on your TV or radio. And how many people will get to know about this call?

Before we begin, beware that the words and organization of sentences will be slightly different with every call as a way of throwing you off board.

Here we go…Beep… Beep!!

Thank you for calling the customer service center for Pfizer-BioNTech COVID-19 vaccine also known as COMIRNATY (COVID-19 Vaccine, mRNA). The licensed COMIRNATY COVID-19 Vaccine has the same formulation as the authorized vaccine Pfizer-BioNTech COVID-19 vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact effect safety or effectiveness.

Before we continue, I need to share the following important information with you:

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  1. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.
  2. It is also authorized under EUA to be administered to:
  • Prevent COVID-19 in individuals 12 through 15 years, and
  • Provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:

  1. Prevent COVID-19 in individuals 12 years of age and older, and
  2. Provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

An individual may be offered either the COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA authorized Pfizer-BioNTech vaccine to prevent COVID-19 for youth and individuals of 12 years of age and older.

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 56(4)(b)(1) of the DNC Act.

Unless the declaration is terminated or authorized revoked sooner, you should not get the Pfizer-BioNTech COVID-19 vaccine.

You should not get the Pfizer-BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of this vaccine or had a severe allergic reaction to any ingredient of this vaccine.

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

  • Have any allergies;
  • Have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart);
  • Have a fever;
  • Have a bleeding disorder or on a blood thinner;
  • Are immunocompromised or on a medicine that affects your immune system;
  • Are pregnant, planning to become pregnant, or are breastfeeding;
  • Have received another COVID-19 vaccine;
  • Have ever fainted in association with an injection.

The vaccine may not protect everyone;

Side effects reported with the vaccine include:

There was a remote chance that the vaccine could cause a severe allergic reaction. Such a severe reaction would usually occur within a few minutes to one hour after getting a dose of the 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:

  • Difficulty breathing;
  • Swelling of your face & throat;
  • A fast heartbeat;
  • A bad rash all over your body;
  • Dizziness;
  • Weakness.

(If you experience a severe allergic reaction, call 911 or go to the nearest hospital).

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 the receipt of the second dose of the vaccine. However, the chance of having this is every low.

You should seek medical attention right away if you have the following symptoms after receiving the vaccine:

  • Chest pain;
  • Shortness of breath;
  • Feelings of having a fast-beating, fluttering, or pounding heart.

Side effects that have been reported with the vaccine include severe and/or non-severe allergic reactions such as:

  • Rash;
  • Itching;
  • Hives or swelling of the face;
  • Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart);
  • Injection site pain;
  • Tiredness;
  • Headache;
  • Muscle pain;
  • Chills;
  • Joint pain;
  • Fever;
  • Injection site swelling;
  • Injection site redness;
  • Nausea;
  • Feeling unwell;
  • Swollen lymph nodes;
  • Lymph adenopathy;
  • Diarrhea;
  • Vomiting;
  • Arm pain.

These MAY NOT be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine IS STILL BEING STUDIED for clinical trials.

Under the EUA, it is your choice to receive or not receive the vaccine. Should you
decide not to receive it, it will not change your standard medical care.

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

There is NO INFORMATION on the use if this vaccine with other vaccines;

Patients should always ask their healthcare provider for medical advice about adverse events report, negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html.

Stay tuned for more guidance, enlightenment, and counsel. In the interim, if there are any questions or comments, please let us know at the Contact Us page!