Vaccine Information Statements
VACCINE INFORMATION STATEMENTS
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Vaccine Information Statements
There are 3 Official documents that everyone taking a Vaccine has the right to view:
Vaccine Emergency Use Authorization Fact Sheet – (Covid as of May 2025 for children 6 mos - 11)
Vaccine Information Statement
Vaccine Package Insert
Vaccine Information Statements must be shown or given to patients prior to receiving a vaccine. It is Federal Law.
Federal Law requires a healthcare professional to provide a copy of the current Vaccine Information Statements or VIS to an adult patient or to a child’s parent or legal representative before vaccinating an adult or child with a dose of the following vaccines1:
Diphtheria - DTaP and Tdap
Tetanus -- DTaP and Tdap
Pertussis -- DTaP and Tdap
Measles -- MMR
Mumps -- MMR
Rubella -- MMR
Hepatitis A
Hepatitis B
Haemophilus Influenzae type b (Hib),
Human Papillomavirus - (HPV)
Meningococcal – MenACWY & MenB
Pneumococcal Conjugate
Polio
Rotavirus
Varicella - Chickenpox
Yes, it is legally required.
This is stated under the 1986 National Childhood Injury Act.
Other vaccines are not required by Federal Law to issue Vaccine Information Statements, UNLESS they have been purchased under CDC contract.
The CDC does recommend that Vaccine Information Statements be used for all vaccines.
When administering a Vaccine under Emergency Use Authorization (EUA), an EUA Fact Sheet must be used.
FACTS:
Vaccine Information Statements can be given to patients in Paper form or by Electronic Media.
VIS’s are required in both Public and Private Healthcare facilities.
A Patient MUST be provided a VIS by a Healthcare Worker BEFORE a Vaccine is Administered.
Healthcare Workers MUST provide a VIS for EACH Dose of Vaccine Administered.
Healthcare Workers MUST provide a VIS for Combination Vaccines.
VIS’s must be given in a language the patient understands.
Federal Law does NOT require Signed Consent.
Verification: Providers MUST Verify that a VIS was given for each vaccine or combo vaccines in the Patient’s Medical Record or Permanent Office Log or File the following Information:
A. The edition date of the VIS (found on the back at the right bottom corner).
B. The date the VIS is provided (i.e., the date of the visit when the vaccine is administered).
C. The office address and name and title of the person who administers the vaccine.
D. The Date the vaccine is administered.
E. The vaccine manufacturer and LOT NUMBER
As of January 31, 2025, the most recent versions of the VISs are:
Adenovirus – 1/8/2020
Anthrax – 1/8/2020
COVID-19 – 1/31/2025 – *Emergency Use Authorized
Cholera – 1/31/2025
Dengue – 1/31/2025
DTaP – 8/6/2021
Ebola – 1/31/2025
Hepatitis A – 1/31/2025
Hepatitis B – 1/31/2025
Hib – 8/6/2021
HPV – 8/6/2021
Influenza – 1/31/2025
Japanese Encephalitis – 8/15/2019
MenACWY – 1/31/2025
MenB -- 1/31/2025
MMR – 1/31/2025
MMRV -- 1/31/2025
|
Multi-Vaccine – 7/24/2023
PCV – 5/12/2023
PPSV23 – 10/30/2019
Polio – 1/31/2025
Rabies – 6/2/2022
RSV Antibody – 9/25/2023
RSV Vaccine – 1/31/2025
Rotavirus – 10/15/2021
Smallpox / Monkeypox – 1/31/2025
Td – 8/16/2021
TDaP – 1/31/2025
Tick Borne Encephalitis – 12/7/2023
Typhoid – 10/30/2019
Varicella – (Chickenpox) – 1/31/2025
Yellow Fever – 4/1/202
Zoster -- 2/4/2022 |
Example of the new 1/31/2025 COVID-19 Vaccine Information Statement2:
COVID-19 Vaccine: What You Need to Know
1. Why Get Vaccinated? |
2. COVID-19 Vaccine |
COVID-19 vaccine can prevent COVID-19 disease. Vaccination can help reduce the severity of COVID-19 disease if you get sick.
COVID-19 is caused by a coronavirus called SARS-CoV-2 that spreads easily from person to person. COVID-19 can be mild to moderate, lasting only a few days, or it can be severe, requiring hospitalization, intensive care, or a ventilator to help with breathing. COVID-19 can also result in death.
COVID-19 symptoms may appear 2 to 14 days after exposure to the virus. A person can have mild, moderate, or severe symptoms.
Symptoms can include fever; chills; cough; shortness of breath or difficulty breathing; fatigue (tiredness); muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea; vomiting; and diarrhea.
More serious symptoms can include trouble breathing; persistent pain or pressure in the chest; new confusion; inability to wake or stay awake; and pale, gray, or blue colored skin, lips, or nail beds (depending on skin tone).
Older adults and people of any age with certain underlying medical conditions (like heart or lung disease or diabetes) are more likely to get very sick with COVID-19.
After COVID-19 illness, some people get Long COVID, a chronic condition with symptoms lasting 3 months or longer. Symptoms of Long COVID may get better, get worse, or stay the same.
People who are up to date with COVID-19 vaccination have a lower risk of severe illness, hospitalization, and death from COVID-19 than people who are not up to date. COVID-19 vaccination is the best way to prevent Long COVID.
Getting a COVID-19 vaccine helps the body learn how to defend itself from the disease and reduces the risk for severe illness and complications.
Additionally, COVID-19 vaccines can offer added protection to people who have already had COVID-19, including protection against being hospitalized if they become infected with COVID-19 again. |
Updated 2024–2025 COVID-19 vaccine is recommended for everyone 6 months of age and older. This includes women who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future.
2024–2025 COVID-19 vaccines for infants and children 6 months through 11 years of age are available under Emergency Use Authorization from the U. S. Food and Drug Administration (FDA). Please refer to the Fact Sheets for Recipients and Caregivers for more information.
For people 12 years of age and older, 2024–2025 COVID-19 vaccines, manufactured by ModernaTX, Inc. or Pfizer, Inc., are approved by FDA.
Novavax COVID-19 Vaccine Adjuvanted (2024–2025 Formula) vaccine is available under Emergency Use Authorization from FDA for people 12 years and older. Please refer to the Fact Sheet for Recipients and Caregivers for more information.
Everyone 6 months of age and older is recommended to receive an age-appropriate FDA-approved or authorized updated 2024–2025 COVID-19 vaccine.
Certain people, such as those who have medical conditions or are taking medications that affect the immune system, may need additional doses of COVID-19 vaccine. Your health care provider can advise you |
3. Talk with your Healthcare Provider |
4. Risks of a Vaccination Reaction |
Tell your vaccination provider if the person getting the vaccine:
Has had an allergic reaction after a previous dose of COVID-19 vaccine or has any severe, life-threatening allergies
Has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside of the heart).
Has had multisystem inflammatory syndrome (called MIS-C in children and MIS-A in adults).
In some cases, your health care provider may decide to postpone COVID-19 vaccination until a future visit.
People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill, including with COVID-19, should usually wait until they recover.
COVID-19 vaccine may be given at the same time as other vaccines |
Pain, swelling, and redness where the shot is given, fever, tiredness (fatigue), headache, chills, muscle pain, joint pain, nausea, vomiting, and swollen lymph nodes can happen after COVID-19 vaccination.
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been seen rarely after COVID-19 vaccination.
These risks have been observed most frequently in adolescent and young adult males. The chance of this occurring is low.
People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears.
As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.
V-Safe is a safety monitoring system that lets you share with CDC how you, or your dependent, feel after getting COVID-19 vaccine.
You can find information and enroll in V-Safe at vsafe.cdc.gov |
5. What if there is a Serious Problem? |
6. Countermeasures Injury Compensation Program |
An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness), call 9-1-1 and get the person to the nearest hospital.
Seek medical attention right away if the vaccinated person experiences chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after COVID-19 vaccination. These could be symptoms of myocarditis or pericarditis.
For other signs that concern you, call your health care provider
Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at www.vaers.hhs.gov or call 1-800-822-7967. VAERS is only for reporting reactions, and VAERS staff do not give medical advice. |
T he Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit the program’s website at www.hrsa.gov/cicp, or call 1-855-266-2427. |
7. How Can I Learn More?
Ask your health care provider.
Call your local or state health department.
Visit the website of the Food and Drug Administration (FDA) for COVID-19 Fact Sheets, package inserts, and additional information at www.fda.gov/emergency preparedness-and-response/coronavirus-disease-2019 covid-19/covid-19-vaccines.
Contact the Centers for Disease Control and Prevention (CDC):- Call 1-800-232-4636 (1-800-CDC-INFO) or- Visit CDC’s COVID-19 vaccines website at www.cdc.gov/covid/vaccines/index.html. |
An FDA Approval means that there has been a FULL Review and Determination that the Vaccine is Safe & Effective for it’s intended use3.
FDA “Authorization” means the Vaccine is being allowed to be marketed under Emergency Use Authorization, which allows the product to be used during a “Public Health Emergency” without a full approval process.
The COMIRNATY Pfizer Vaccine was approved on August 23, 20214.
The Pfizer COVID-19, the Moderna Spikevax and the Novavax Covid-19 on the CDC Children’s Vaccination Schedule for 2025, beginning at SIX Months of age until age 12 are not approved.
These are NOT FDA Approved but they are under EUA – Emergency Use Authorization. This is information up to date as of May 2025.
For recipients who are 12 or older receiving Pfizer or Moderna vaccine, a provider may use the COVID-19 Vaccine Information Statement (VIS) because there was FDA Approval granted for this age group.
FACT SHEETS – for Vaccines that have been Emergency Use Authorized
Providers are required by law to provide Emergency Use Authorized Fact Sheets to vaccine recipients or their caregivers for all uses when Novavax, Moderna or Pfizer vaccines are given to children 6 months through 11 years of age. These are NOT FDA Approved VaccinesThis is valid as of May of 2025.
This can be confusing because PRIOR to Age 12, a child will receive the Pfizer-BioNTech COVID-19 Vaccine – which providers must provide the EMERGENCY USE AUTHORIZED FACT SHEET.
When a child turns 12, they will receive COMIRNATY – which somehow did receive FDA approval in August of 2021.
The Pfizer Covid Vaccine for children UNDER age 12 is called Pfizer-BioNTech Covid-19 Vaccine and the Vaccine when a child is 12 is called COMIRNATY, as it has full FDA approval for that age group.
As per the Vaccine Package Insert for COMIRNATY:
“COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.”
To Summarize what could be very Confusing for Parents:
Providers are required by law to provide Emergency Use Authorized Fact Sheets to vaccine recipients or their caregivers for all uses when Novavax, Moderna or Pfizer vaccines are given to children 6 months through 11 years of age. This is valid as of May of 2025.
The Novavax Covid-19 vaccine, Moderna's Spikevax jab and Pfizer-BioNTech's Covid-19 vaccines are NOT FDA Approved but still under Emergency Use Authorization.
This means that EUA Fact Sheets MUST be given to Parents.
It is also wise to request to view the VIS - Vaccine Information Statements and the Vaccine Package Inserts for each vaccine.
It is FEDERAL LAW that a Provider MUST give Vaccine Information Statements to a Parent BEFORE Administering ANY Vaccine under the National Childhood Injury Act of 1986 or ANY Vaccine under CDC Contract.
My question is this: “The Covid Public Health Emergency for the USA ended on May 11, 20235 – so how in the world can the CDC recommend a product that has not been approved for children aged 6 months to 12 years?”
The Secretary of Health and Human Services, Robert Kennedy Jr. has the authority to decide if an Emergency Use Authorization is appropriate6.
About EUA’s:
“Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, the FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.”
“The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.”
According to a Yale Medicine article by Carrie Macmillan7:
“An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks.”
“An EUA also only lasts as long as the public health emergency for which it was declared7.”
History of an EUA: “The FDA established its EUA program in 2004 in response to threats of bioterrorist attacks, including anthrax. Later, it was used for H1N1 (swine flu), Ebola, avian flu, and Middle Eastern Respiratory Syndrome (MERS).
The Public Health Emergency ended in May 11, 2023, so why is this EUA still on the CDC Children’s Schedule as of May 2025?
A drug like Ivermectin has been successfully used off label to treat Covid, Cancer and many other conditions.
Merck’s Ivermectin patent expired in 1996, so why doesn’t Merck try to apply for a “New Use” for Ivermectin?
Because that may lead to discover that it can be used to treat many other conditions and in the long-run, it would be bad for all of Big Pharma’s. They love new patented drugs for each labeled medical condition.
It is obviously more about money and much less about health.
Have you ever noticed that once a drug loses it’s patent that it loses promotion from the FDA and CDC? There’s no money in it. They are in bed together.
It is crystal clear as to how RFK Jr. views the mRNA Covid Vaccines for children, so why he hasn’t acted on this?
It could be that there are legality issues and red tape regarding “other treatment options” and also because he will be severely attacked by the Industry and they would just get it FDA approved ASAP even if he did something now, as of May 2025.
Anyway, it is better to be safe than sorry. Ask for as much information as you can receive.
Vaccine Fact Sheets, Vaccine Information Statements and Vaccine Package Inserts all have different pieces of important data. It may be wise to suggest to have all 3 of these if available, but the Vaccine Information Fact Sheets are Federal Law.
Doctors seem to frown on a patient when they request a “Vaccine Insert Package” as they believe that is for their eyes only and the patients receive a Vaccine Information Statement.
Get BOTH and for sure be aware that doctors are required to give these the vaccines listed above.
Also – be aware that for any vaccine that has received Emergency Use Authorization by the FDA, the provider is required to go over a Fact Sheet discussing the risks of using a vaccine that has not been approved by the FDA.
Become Educated.
Become an Expert.
Sources:
1. Centers for Disease Control and Prevention (CDC). Vaccine Information Statements (VISs). 31 Jan. 2025, www.immunize.org/wp-content/uploads/catg.d/p2027.pdf. *Note: These Vaccine Information Statements - VIS’s are Required by Federal Law to be issued to parents prior to be administered to children and adults prior to their vaccinations.
2. “Vaccine Information Statement: COVID-19 Vaccine.” U.S. Centers For Disease Control And Prevention, 31 Jan. 2025, www.cdc.gov/vaccines/hcp/current-vis/downloads/vis.zip. Accessed 11 May 2025. *Note: This is the link to access ALL the Vaccine Information Statements, including COVID-19 Vaccine.
3. U.S. Food and Drug Administration. “Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19.” U.S. Food And Drug Administration, 13 Apr. 2023, www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventative-and-therapeutic-drugs-covid-19. *Note: Defining FDA Approval vs EUA.
4. U.S. Food and Drug Administration. “FDA Approves First COVID-19 Vaccine.” U.S. Food And Drug Administration, 23 Aug. 2021, www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
5. End of the Federal COVID-19 Public Health Emergency (PHE) Declaration | CDC. archive.cdc.gov/www_cdc_gov/coronavirus/2019-ncov/your-health/end-of-phe.html.
*Note: Public Health Emergency Ended on May 11, 2023, but Vaccines will still be available. Kind of sounds that was an Agenda to get mRNA’s in the door and gain momentum for the vaccine platform of the future.
6. Office of the Commissioner. “Emergency Use Authorization.” U.S. Food And Drug Administration, 23 Dec. 2024, www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. *Note: Information about EUA - Emergency Use Authorization, Secretary of HHS declares if an EUA is appropriate. RFK Jr can decide.
7. MacMillan, Carrie. “Emergency Use Authorization Vs. Full FDA Approval: What’s the Difference?” Yale Medicine, 7 Mar. 2022, www.yalemedicine.org/news/what-does-eua-mean. *Notes: An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. An EUA also only lasts as long as the public health emergency for which it was declared. Also goes through FDA Approval and EUA process.
© Jeff Linke
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