Know the Risks – National Vaccine Information Center (NVIC)

The non-profit (501c3) charity National Vaccine Information Center (NVIC) was established in 1982 by parents of DPT vaccine injured children to prevent vaccine injuries and deaths through public education. NVIC co-founders worked with Congress to secure vaccine safety informing, recording, reporting and research provisions in the National Childhood Vaccine Injury Act of 1986. ¹NVIC does not make vaccine use recommendations. NVIC advocates for protection of human rights, including the right to autonomy and freedom of thought, speech and conscience, and supports the ethical principle of informed consent to medical risk taking. ^{2 3 4 5}  NVIC works to secure informed consent protections, including flexible medical, religious and conscientious belief exemptions to vaccination, in public health policies and laws. ⁶ NVIC supports adoption of the precautionary principle based on the Hippocratic “first, do no harm” approach to public health policymaking. ^{7 8}To encourage well-informed and voluntary vaccine decision-making, NVIC sponsors national vaccine education campaigns. In 2011, NVIC sponsored a digital vaccine education billboard in New York City’s Times Square on New Year’s Eve and produced a flu prevention video for Delta Airline’s in-flight programming. In 2013, NVIC launched a national vaccine education billboard and ad campaign that featured billboards on highways and buses New Jersey, Pennsylvania, Oregon, Washington, Arizona, Illinois, Texas, Georgia and Colorado, Vermont and other states. In 2015 and 2016, NVIC’s message advocating for vaccine education and choice was up in Times Square, as well.

NVIC’s “Vaccination: Know the Risks and Failures” and “No Forced Vaccination” animated digital message was up in Times Square between February and April 2019. After the New York state legislature eliminated the religious exemption to vaccination in June 2019 and state health officials also effectively eliminated the medical exemption, NVIC is once again displaying our “No Forced Vaccination” message on a giant 56 foot by 29 foot electronic screen in the heart of Times Square Plaza at 1500 Broadway (where the ball drops on New Year’s Eve).

More than one million people pass through Times Square daily. NVIC’s 10-second spot (as seen at the top of this screen – click on it to view) will be broadcast a minimum of three times per hour for 20 hours per day from 6 a.m. to 2 a.m. from Oct. 14, 2019 through Jan. 31, 2020, which includes the Thanksgiving Day parade and New Year’s Eve events.

U.S. Congress and Institute of Medicine Confirm Government Licensed and Recommended Vaccines Can Cause Injury and Death

Like prescription drugs, vaccines are commercial pharmaceutical products that carry two risks: a risk the vaccine product will fail to work ^{9 10} and a risk the vaccine product will cause harm. ^{11 12} However, unlike with prescription and over the counter drugs, manufacturers of vaccines and doctors who administer vaccines have no liability when a person is injured or dies after being given a recommended childhood vaccine licensed by the U.S. Food and Drug Administration (FDA) as safe and effective.

In 1986, Congress passed the National Childhood Vaccine Injury Act and codified into law government acknowledgement that federally licensed and  recommended and state mandated vaccines can and do unpredictably cause injury and death.  The Act created a federal vaccine injury compensation program (VICP) alternative to a vaccine injury lawsuit against drug companies. ¹³ By 2019, the VICP had awarded more than $4 billion in federal compensation to vaccine injured children and adults. ¹⁴

Learn more about how to file a claim in the federal vaccine injury compensation program.

In 2011 in a split decision in Bruesewitz v. Wyeth, the US Supreme Court majority ruled that vaccines are “unavoidably unsafe” and effectively removed all liability from drug companies, even if there was evidence a drug company could have made a vaccine safer. ^{15 16}

In a series of reports published between 1991 and 2013, the Institute of Medicine affirmed that scientific evidence demonstrates that vaccines can cause injury and death and that some people are genetically, biologically and environmentally at higher risk for being harmed by vaccines but doctors do not know how to identify who they are before vaccination. ^{17 18 19 20 21}  Even so, federal health officials have narrowed contraindications to vaccination and eliminated almost all health conditions from qualifying for a medical exemption to vaccination. ²²

When liability free pharmaceutical products can cause injury and death, especially when some people are biologically more vulnerable to suffering harm but doctors do not know how to predict who they are, protection of the human right to informed consent to medical risk taking becomes even more important. ²³ The legal right to exercise flexible medical, religious and conscientious belief exemptions to vaccination ensures that human rights are protected in public health policies and laws. ²⁴

VACCINATIONS: KNOW THE RISKS

Like the first vaccine for smallpox, ²⁵ every vaccine licensed by the U.S. Food and Drug Administration (FDA) and recommended by Centers for Disease Control (CDC) officials and medical trade associations carries a risk for serious complications, such as brain inflammation, which can lead to chronic brain and immune system damage or death. ^{26 27 28 29 30}   

There is a wide spectrum of vaccine complications, which have been identified and acknowledged in the medical literature and by the Institute of Medicine (IOM), National Academy of Sciences, including:  ³¹

• Brain Inflammation/Acute Encephalopathy
• Chronic Nervous System Dysfunction
• Anaphylaxis
• Febrile Seizures
• Guillain Barre Syndrome (GBS)
• Brachial Neuritis;
• Acute and Chronic Arthritis
• Thrombocytopenia
• Smallpox, polio, measles and varicella zoster vaccine strain infection
• Death (smallpox, polio and measles vaccine)
• Shock and “unusual shock-like state”
• Protracted, inconsolable crying
• Syncope
• Deltoid Bursitis

Individual Susceptibility to Vaccine Reactions

In 2012, the IOM published a report, Adverse Effects of Vaccines: Evidence and Causality, ³² and acknowledged there are genetic, biological and environmental high risk factors not yet identified that can increase “individual susceptibility” to vaccine reactions but most of the time doctors cannot predict who is at risk:

“Both epidemiologic and mechanistic research suggests that most individuals who experience an adverse reaction to vaccines have a pre-existing susceptibility. These predispositions can exist for a number of reasons – genetic variants (in human or microbiome DNA), environmental exposures, behaviors, intervening illness or developmental stage, to name just a few, all of which can interact. Some of these adverse reactions are specific to the particular vaccine, while others may not be. Some of these predispositions may be detectable prior to the administration of vaccine; others, at least with current technology and practice, are not.” – Institute of Medicine ³³ 

Gaps in Knowledge About Individual Risks

In 2013, the IOM published another report, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies, ³⁴ which studied the scientific evidence regarding the safety of the CDC’s recommended vaccine schedule for children from birth to age six. The IOM committee evaluating the evidence stated that there are significant gaps in scientific knowledge about children, who are biologically at higher risk for suffering vaccine injury and death:

“ The committee found that evidence assessing outcomes in subpopulations of children, who may be potentially susceptible to adverse reactions to vaccines (such as children with a family history of autoimmune disease or allergies or children born prematurely), was limited and is characterized by uncertainty about the definition of populations of interest and definitions of exposures or outcomes.” – Institute of Medicine ³⁵

Current Early Childhood Vaccine Schedule: More Testing Needed

The CDC’s childhood vaccine schedule recommends all children receive 69 doses of 16 vaccines with 50 doses of 14 vaccines given between the day of birth and age 18. ³⁶  The majority of children in the U.S. today receive three times as many vaccinations as children received in 1983. ³⁷

The 2013 IOM Committee, which examined the safety of the current federally recommended early childhood vaccine schedule found that it had not been fully scientifically evaluated:

 “Most vaccine-related research focuses on the outcomes of single immunizations or combinations of vaccines administered at a single visit. Although each new vaccine is evaluated in the context of the overall immunization schedule that existed at the time of review of that vaccine, elements of the schedule are not evaluated once it is adjusted to accommodate a new vaccine. Thus, key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines – have not been systematically examined in research studies;” – Institute of Medicine ³⁸

Outstanding Questions About Vaccines & Chronic Illness

Due to a lack of enough methodologically sound studies conducted and published in the medical literature, the 2013 IOM Committee was unable to determine if the early childhood vaccine schedule recommended by the CDC and medical trade associations is or is not associated with the development of the following chronic brain and immune disorders and disabilities in children: ³⁹

• asthma;
• atopy;
• allergy;
• autoimmunity;
• autism;
• learning disorders;
• communication disorders;
• developmental disorders;
• intellectual disability;
• attention deficit disorder;
• disruptive behavior disorder;
• tics and Tourette’s syndrome;
• seizures;
• febrile seizures and
• epilepsy.

Identifying Symptoms of Vaccine Reactions

Not every serious health problem that occurs after vaccination is caused by a vaccine or combination of vaccinations recently received. Different vaccines are associated with different vaccine reaction signs and symptoms that occur within different time periods following vaccination.

It is important to know how to identify a vaccine reaction. ⁴⁰ Serious complications of vaccination can lead to permanent injury or death. If a recently vaccinated child or adult exhibits a dramatic change in physical, mental or emotional behavior or unusual symptoms that may indicate a serious vaccine reaction is in process, that person should be immediately taken to a hospital emergency room.

It is very important to contact a doctor if symptoms listed below occur in the hours, days or weeks following vaccination:

• pronounced swelling redness, heat or hardness at injection site that continues for days or weeks;
• body rash or hives;
• shock/collapse;
• unresponsiveness, prolonged deep sleep;
• high pitched screaming (may include arching of back);
• hours of persistent, inconsolable crying;
• high fever (over 103 F)
• respiratory distress (difficulty breathing);
• twitching or jerking of the body, arm, leg or head;
• rolling or crossing of eyes;
• severe head or neck pain;
• joint pain or muscle weakness;
• disabling fatigue;
• loss of memory and mental skills;
• paralysis of any part of body;
• changes in sleep/wake pattern and dramatic personality changes;
• lack of eye contact or social withdrawal
• loss of ability to roll over, sit up or stand up
• head banging or unusual flapping, rubbing, rocking, spinning;
• onset of chronic ear or respiratory problems (including asthma);
• severe/persistent diarrhea or chronic constipation;
• excessive bruising, bleeding or anemia
• other serious loss of physical, mental or emotional wellness

The Vaccine Adverse Events Reporting System (VAERS)

Doctors, nurses, pharmacists and other vaccine administrators are required by federal law to record serious health problems, hospitalizations and injuries that occur after vaccination in a person’s permanent medical record and to report serious health problems following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS). The co-founders of NVIC secured informing, recording, reporting and research safety provisions in the 1986 National Childhood Vaccine Injury Act that requires doctors and any person who administers a vaccine to a child or adult in the U.S. to:

1. Provide written vaccine benefit and risk information before vaccination takes place;
2. Keep a permanent record of all vaccinations given, including the manufacturer’s name and vaccine lot number;
3. Record symptoms of serious health problems in the patient’s permanent medical record;
4. Make a report to the federal Vaccine Adverse Events Reporting System (VAERS) of serious health problems, hospitalizations, injuries and deaths that occur following vaccinations;

It is estimated that only about one percent of all adverse events following vaccination, including injuries and deaths, are reported to VAERS. ^{41 42}  If a doctor or other vaccine provider refuses to make a vaccine adverse event report to VAERS, the person or family of the person, who has suffered a serious health problem after vaccination, can make the report directly to VAERS.

Learn more about how to report vaccine reactions to VAERS and to NVIC here.

Search the government’s VAERS database and view descriptions of vaccine reaction reports filed with VAERS since 1990 here.

PREVENTING VACCINE REACTIONS

After Congress passed the National Childhood Vaccine Injury Act of 1986^, to give drug companies marketing vaccines in the U.S. a liability shield from vaccine injury lawsuits, the “first, do no harm” precautionary approach to vaccination by doctors and other vaccine administrators changed. Reasons for delaying or not giving a child federally recommended and state mandated vaccines were revised by public health officials and medical trade associations so that fewer children qualified for a medical exemption to vaccination, such as when children suffer convulsions/seizures, high pitched screaming or collapse/shock (hypotonic hyporesponsive episodes) after receiving pertussis-containing vaccines. ^{43 44}

The prevention of vaccine reactions became less of a priority after Congress amended the Act in 1987 to extend vaccine injury lawsuit liability protection to doctors and other vaccine administrators. Then, with the assistance of DHHS exercising rulemaking authority, between 1989 and 1995 Congress added more amendments to the Act to weaken the law’s vaccine safety and compensation provisions. ^{45 46}

After 2011, when the U.S. Supreme Court effectively removed all liability from vaccine companies, public health officials and medical trade associations stepped up pressure on state legislatures to restrict or remove non-medical vaccine exemptions for religious and conscientious or philosophical beliefs. Doctors were told by vaccine policymakers to strictly conform to narrow CDC contraindications for giving medical exemptions rather than exercise professional judgment in exempting children from government recommended and mandated vaccinations. ^{47 48} Today, even children with severe immune system dysfunction, including those with cancer and HIV and following organ transplants, are candidates for vaccination under most medical guidelines for vaccination. ⁴⁹

California eliminated the personal belief vaccine exemption in 2015. ⁵⁰ Like in West Virginia and Mississippi, this left California with only a medical vaccine exemption. ⁵¹ There are lobbying efforts by medical groups in California and other states to further restrict the medical exemption to vaccination to compel all doctors administering vaccines to conform to narrow CDC approved contraindications to vaccination. ⁵²

Vaccine Manufacturer Product Information Package Inserts

Although government contraindication and medical exemption guidelines recognize few medical conditions as a reason to exercise caution or not vaccinate a child or adult, ⁵³ it is very important to read the vaccine manufacturer product information package inserts before receiving a vaccine because contraindications and precautions may differ from government recommendations. The FDA requires vaccine manufacturers to publish certain types of information for licensed vaccines to inform both vaccine administrators and vaccine recipients about the vaccine’s vaccine ingredients; ages and circumstances for use of the vaccine; descriptions of vaccine pre-licensure clinical trial results; post-marketing vaccine reaction reports, as well as what the vaccine manufacturer considers a contraindication (reason not vaccinate) or precaution to use of the vaccine. ⁵⁴

Read vaccine manufacturer product information package inserts for vaccines recommended by the CDC on NVIC’s website here or on the FDA website here.

Read NVIC’s “If You Vaccinate, Ask 8 Questions” brochure about what you need to know before and after vaccination to help prevent vaccine reactions, injuries and deaths.

VACCINATIONS: KNOW THE FAILURES

Vaccines may provide temporary immunity but sometimes fail to provide individuals with even short-term protection from infection. Pertussis, influenza and mumps vaccines are three examples. Fully vaccinated children and adults can and do transmit pertussis, influenza, mumps and other infections to others.

Pertussis Vaccine: Waning Immunity

“Getting sick with pertussis or getting pertussis vaccines doesn’t provide lifelong protection. This means you can still get pertussis and pass it onto others, including babies…Pertussis vaccines are effective, but not perfect. They typically offer good levels of protection within the first 2 years after getting the vaccine, but then protection decreases over time. Public health experts call this ‘waning immunity.” – Centers for Disease Control (2017) ⁵⁵

1. pertussis whooping cough is a bacterial infection that can be very serious for young infants. Both whole cell pertussis vaccine in DPT shots, which were replaced in 1996 in the U.S. by acellular pertussis vaccine in DTaP shots, only provide temporary immunity and current pertussis vaccines do not contain B. pertussis strains that have evolved to evade the vaccines and are widely circulating today. Unvaccinated and fully vaccinated persons can become infected with B. pertussis whooping cough and transmit it to other people, sometimes showing few or no symptoms. ⁵⁶

The CDC states, “Older siblings, parents, or caregivers who might not know they have the disease infect many babies who get pertussis. If pertussis is circulating in the community, there’s a chance that even a fully vaccinated person of any age can catch this very contagious disease. But if you received pertussis vaccines, your infection is usually less serious.” ⁵⁷

In 2017, 94 percent of children aged 18 to 35 months had received three or more doses of pertussis containing DTaP vaccine. ⁵⁸ In the 2017-2018 school year, more than 95 percent of children entering kindergarten had received four or five doses of pertussis containing DTaP vaccines. ⁵⁹ In 2017, more than 88 percent of adolescents between ages 13 and 17 years old in the U.S. had received a sixth dose of pertussis containing vaccine, the Tdap booster shot. ⁶⁰

Symptoms of B. pertussis:  When symptoms of whooping cough are present, they can include a runny nose, low grade fever and mild cough for one to two weeks that progresses to fits of violent coughing followed by a high pitched whooping sound (primarily in infants and young children) with vomiting up of thick, sticky mucus and extreme fatigue after spasmodic coughing spells. ⁶¹ Infants can stop breathing when the sticky mucus clogs tiny airways. If pertussis is suspected in an infant or young child, a doctor should be called immediately.

Known as the “100 day cough,” pertussis infections with symptoms take weeks to fully resolve but most healthy people recover from whooping cough without complications. However, serious complications can occur and include pneumonia, brain inflammation, convulsions and death.

Learn more about the signs, symptoms and complications of B. pertussis infection and pertussis vaccine here.

Influenza Vaccine: Limited Effectiveness

“Recent studies show that flu vaccination reduces the risk of flu illness by between 40% and 60% among the overall population during seasons when most circulating flu viruses are well-matched to the flu vaccine… How well the flu vaccine works (or its ability to prevent flu illness) can vary from season to season. The vaccine’s effectiveness also can vary depending on who is being vaccinated… During years when the flu vaccine is not well matched to circulating influenza viruses, it is possible that little or no benefit from flu vaccination may be observed.”  – Centers for Disease Control (2018) ⁶²

Seasonal influenza vaccines contain three or four type A and B influenza viruses that public health officials have predicted will be the ones circulating most prevalently during the flu season. However, influenza vaccines historically have provided very limited protection against circulating influenza viruses during most flu seasons. ⁶³

According to the CDC, between 2004 and 2018, the influenza vaccine was less than 50 percent effective preventing circulating strains of influenza for 10 out of 14 flu seasons. ⁶⁴ In three flu seasons, the influenza vaccine was only between 10 and 21 percent effective.

Influenza-like-illness (ILI) symptoms, such as fever, sore throat, congestion, cough, body aches and fatigue that are severe enough to prompt a trip to the doctor, rarely turn out to be actual type A or B influenza infection. Typically, when the CDC tested specimens of influenza-like-illness cases, only between 3 percent and 18 percent are positive for type A or B influenza. ⁶⁵

Vaccinated and unvaccinated persons can have influenza and show few or no symptoms and transmit the infection to other people. A study published in 2014 found that 75 percent of people with seasonal and pandemic influenza have no symptoms.⁶⁶

Symptoms of influenza: There are two major influenza types (A and B) and when symptoms are present, they can include high fever, chills, sore throat, fatigue and weakness, muscle and body aches, cough, chest pain, trouble breathing, diarrhea and vomiting that can last for more than a week. Most healthy people recover from influenza without complications. However, serious complications of influenza include dehydration, bacterial ear and sinus infections, bronchitis, pneumonia and, more rarely, sepsis, inflammation of the heart, muscles or brain, and death. ⁶⁷

Learn more about the signs, symptoms and complications of influenza and influenza vaccine here.  

Mumps Vaccine: Outbreaks in the Fully Vaccinated

During the past 15 years, there have been mumps outbreaks in the U.S. and other countries in fully vaccinated populations that have received two doses of mumps containing (MMR) vaccines. ^{68 69}  Waning vaccine acquired immunity is thought to be the cause.

In 2017, more than 91 percent of children in the U.S. aged 17 to 35 months had received one or more doses of mumps containing MMR vaccine, ⁷⁰ and 94 percent of children entering kindergarten had received two doses of mumps containing MMR vaccine, ⁷¹ and about 92 percent of teenagers had received two doses of mumps containing MMR vaccine. ⁷²

Symptoms of Mumps: The most common symptoms of mumps infection include fever, headache, muscle aches, fatigue, loss of appetite, and swollen, tender salivary glands under the ears on one or both sides that can last for several weeks. The CDC states, “Some people who get mumps have very mild or no symptoms, and often they do not know they have the disease. Most people with mumps recover completely in a few weeks.” ⁷³

Learn more about the signs, symptoms and complications of mumps and mumps containing MMR vaccine here.

Identifying Symptoms of Infectious Diseases

Like each different vaccine, each infectious disease has different signs and symptoms that occur within different time periods following infection. Some of the serious complications of vaccinations, such as brain inflammation, are also serious complications of infectious diseases.

If symptoms of serious complications occur with an infectious disease or after vaccination, it is very important to immediately call a physician or go to an emergency room.

References:

*Source: Know the Risks | National Vaccine Information Center (NVIC)