Transcend The ‘Vaccine’

Healthcare providers are required to report to VAERS the following adverse events after COVID-19 vaccination [under Emergency Use Authorization (EUA)], and other adverse events if later revised by CDC:

• Vaccine administration errors, whether or not associated with an adverse event (AE)
• Serious AEs regardless of causality. Serious AEs per FDA are defined as:
  1. Death;
     
  2. A life-threatening AE;
  3. Inpatient hospitalization or prolongation of existing hospitalization;
  4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
  5. A congenital anomaly/birth defect;
  6. An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
• Cases of Multisystem Inflammatory Syndrome
• Cases of COVID-19 that result in hospitalization or death
  More details here: https://vaers.hhs.gov/faq.html
  

The VAERS website provides a downloadable PDF (Reportable Events Table) on what adverse events are relative to each type of vaccine. However, the PDF appears to be from 2017 and not updated since. Their FAQ page does state this however:

"We encourage you to report any clinically important medical event or health problem that occurs after vaccination. Report the adverse event even if you are not sure if it was a result of vaccination. Healthcare professionals are required by law to report certain adverse events." (emphasis added)

The Reportable Events Table includes this note pertaining to events reportable according to law: "including conditions found in the manufacturer package insert". See below for what a Package Insert is.

Also reportable is "An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine"... See below for what a contraindication is.

Manufacturers of vaccines are required to identify what is in a vaccine. 

"The 1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions on foods, drugs, cosmetics, and medical devices." - Source

For examples of Package Inserts in the 'approved' vaccines, see below:

1. https://www.vaccinesafety.edu/package_inserts.htm
2. https://vaccines.procon.org/vaccine-ingredients-and-manufacturer-information/
   

A contraindication is a specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the person.

There are two types of contraindications:

1. Relative contraindication means that caution should be used when two drugs or procedures are used together. (It is acceptable to do so if the benefits outweigh the risk.)
2. Absolute contraindication means that event or substance could cause a life-threatening situation. A procedure or medicine that falls under this category must be avoided.
   

Source: https://medlineplus.gov/ency/article/002314.htm

"Anyone can submit a report to VAERS, including parents and patients." - you can report online here or download a PDF form to complete manually here. Instructions on the site are in English and Spanish.  

Do you know of anyone who has been affected? Can you tell them about the VAERS database and who can report?

Important:

1.  Anyone can report an adverse event to VAERS
2. Healthcare professionals are required to report certain adverse events
3. Vaccine manufacturers are required to report all adverse events that come to their attention

What if you wrote to your healthcare provider and asked a few questions?

1. Are you aware of VAERS?
2. Do you know about the legal requirements and reportable events pertaining to VAERS?
   
3. Are you following the law? Are you reporting all adverse events to VAERS?
   
4. Have you made the vaccine manufacturer aware of any adverse events?

For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination. This is accomplished by providing an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content to vaccine information statements (VISs) for licensed vaccines but differs in that the EUA Fact Sheet is specific to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by the FDA.

There is no VIS for COVID-19 vaccines authorized under an EUA. Instead, the FDA-issued EUA Fact Sheet for Recipients and Caregivers for each COVID-19 vaccine must be used.

Source; with links to each Fact Sheet below: https://www.cdc.gov/vaccines/covid-19/eua/index.html

• COVID-19 Pfizer BioNTech Vaccine EUA Fact Sheet for Recipients
• COVID-19 Moderna Vaccine EUA Fact Sheet for Recipients
• COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients
• COVID-19 Janssen Vaccine EUA Fact Sheet for Recipients
  

Extract from the Phizer Fact Sheet:

The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.

The EUA is dependent on their being no "adequate, approved, available alternatives" - meaning even if there are available adequate alternatives, if it is not approved, then an EUA may be granted.

Also note, that it is based on the benefits outweighing the risks... ans thus the importance of reporting to VAERS all adverse events.

21 US code BBB - 3 (Print it and use it) Https://www.law.Cornell.edu/uscode/text/21/360bbb-3
Federal law that pertains to people’s right to accept or REFUSE emergency use authorized products, which include masks, PCR tests, and Covid vaccines:
Scroll down to
(e) Conditions of Authorization
   (1) Unapproved Product
      (A) Required Conditions
       ...
            (ii) Appropriate conditions designed to ensure that individuals to whom the product are administered are informed -
   ...
                   (II) of the significant known and potential benefits AND RISKS of use, and of the extent to which such benefits and risks are UNKNOWN; and
     
                   (III) of the option to accept OR REFUSE administration of the product, of the consequences, if any of refusing administration of the product, and of alternatives to the product that are available and if their benefits and risks.

Extract from the Phizer Fact Sheet:

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
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:
• severe allergic reactions
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• diarrhea
• vomiting
• arm pain
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 still being studied in clinical trials.

What is unknown is the duration side effects may take before becoming evident.