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Like prescription drugs, vaccines are pharmaceutical products that carry two risks: a risk the product will not work and a risk the product will cause harm. 
 
The National Vaccine Information Center (NVIC) is a non-profit 501C3 charity founded in 1982 to prevent vaccine injuries and deaths through public education. [1]  NVIC advocates for informed consent in medical research and medical policies and public health laws, including flexible exemptions in vaccine policies and laws for health reasons and for religious and conscientiously held beliefs. [2] ,[3] [4] [5] [6]
 
NVIC also supports adoption of the precautionary principle based on the Hippocratic “first, do no harm” approach to public health policymaking and in shared medical decision-making by doctors with patients. [7] [8] 

 
VACCINATIONS: KNOW THE RISKS
 
Like the first vaccine for smallpox, every vaccine recommended today by government health officials and medical trade associations carries a risk for complications, such as brain inflammation, which can lead to chronic brain and immune system damage or death. [9] [10] [11] [12] [13]
 
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: [14] [15] [16] [17] [18] 
  • 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,[19] and acknowledged there are high risk factors not yet identified by medical science that can increase “individual susceptibility” to vaccine reactions:
 
“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, 2012 [20]
 
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, [21] and stated 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, 2013 [22]
 
Current Vaccine Schedule: More Testing Needed
 
The IOM Committee, which examined the safety of the current federally recommended 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 (2013) [23]
 
Outstanding Questions About Vaccines & Chronic Illness
 
Due to a lack of enough methodologically sound studies conducted and published in the medical literature, the IOM Committee examining the safety of the current childhood vaccine schedule was unable to determine if the schedule is or is not associated with the development of the following chronic brain and immune disorders and disabilities in children: [24]
  • 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 vaccinations recently received. Different vaccines are associated with different vaccine reaction signs and symptoms that occur within different time periods following vaccination.
 
If symptoms listed below occur in the hours, days or weeks following vaccination, it is very important to immediately contact a doctor: 
  • 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
Serious complications of vaccination can lead to permanent injury or death. Make sure that all health problems, hospitalizations and injuries that occur after vaccination are entered into permanent written and electronic medical records and written copies are kept by the person vaccinated or parent/guardian of that person.
 
Learn more about how to recognize vaccine reaction symptoms and complications associated with the 17 different vaccines recommended by the CDC and medical trade associations here.
 
1986 National Childhood Vaccine Injury Act
 
In 1986, Congress passed the National Childhood Vaccine Injury Act. [25] The law was created by Congress in response to lobbying by the pharmaceutical industry and medical trade associations to shield drug companies and doctors from civil product liability and malpractice lawsuits for injuries and deaths caused by federally recommended and state mandated vaccines.
 
The law, which acknowledged that vaccines carry serious risks, created a federal vaccine injury compensation program (VICP). [26]  By 2013, the VICP had awarded more than $2.6 billion to vaccine injured individuals and their families; however two out of three vaccine injury claims are rejected for compensation. Injuries and deaths from pertussis-containing vaccines lead in the numbers of compensation awards, followed by influenza vaccine, MMR vaccine and hepatitis B vaccine. [27]
 
Read more about the federal vaccine injury compensation program here.
 
The Vaccine Adverse Events Reporting System (VAERS)
 
The co-founders of NVIC secured informing, recording and reporting safety provisions in the 1986 National Childhood Vaccine Injury Act. Under federal law, doctors and all vaccine providers in the U.S. are required 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 between one and 10 percent of all vaccine adverse events are reported to VAERS.[28] [29] 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.
 
Make a vaccine reaction report directly to VAERS here.

Search the MedAlerts electronic database of vaccine adverse events reports made to VAERS here.
 
 
VACCINATIONS: PREVENTING VACCINE REACTIONS
 
The “first, do no harm” approach to vaccination changed after Congress passed the National Childhood Vaccine Injury Act of 1986 [30] shielding doctors and vaccine manufacturers from vaccine injury lawsuits.[31] After the law was passed, there was less emphasis on vaccine reaction prevention [32] as public health officials and medical trade associations narrowed the definition of what constitutes a serious vaccine reaction - like convulsions/seizures, high pitched screaming and collapse/shock (hypotonic hyporesponsive episodes) associated with pertussis-containing vaccines.[33][34] 
 
Today, CDC and medical trade association officials list very few vaccine-related adverse events or existing health problems as an “official” medical reason to exercise caution or not vaccinate a child or adult. [35]
 
However, it is very important to read the vaccine manufacturer product information statements to learn more about results of pre-licensure clinical trials and post-marketing vaccine reaction reports, as well as what the vaccine manufacturer considers a contraindication (reason not vaccinate) to use of a particular vaccine.
 
Access product manufacturer information statements for each of the 17 vaccines recommended by the CDC and medical trade associations here.
 
Read NVIC’s “If You Vaccinate, Ask 8 Questions” brochure to help prevent vaccine reactions, injuries and deaths here.
 
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
 
  If pertussis is circulating in the community, there is still a chance that a fully vaccinated person can catch this very contagious disease. When you or your child develops a cold that includes a prolonged or severe cough, it may be pertussis. The best way to know is to contact your doctor”– Centers for Disease Control (2013)[36]
 
According to the CDC, “there is a high vaccination coverage for children nationwide” with pertussis containing vaccines, although vaccine acquired immunity fades within two years of vaccination. Naturally acquired pertussis immunity from the infection also confers immunity. The CDC states “If your doctor confirms that you have pertussis, your body will have a natural defense (immunity) to future infections. Some observational studies suggest that pertussis infection can provide immunity for 4-20 years.” [37]
 
In 2012, 95% of children entering kindergarten in the U.S. had received four or five pertussis-containing vaccines [38] and in 2011 nearly 80% of teenagers had gotten a sixth pertussis vaccine booster dose (Tdap) after age 10. [39] In 2012, CDC officials stated that unvaccinated individuals are “not fueling the large scale outbreaks or epidemics” of pertussis in the U.S. [40]
 
Symptoms of pertussis infection: 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 (in infants and young children) with vomiting up of thick, sticky mucus and fatigue after coughing spells. [41] Infants can stop breathing and if pertussis is suspected, a doctor should be called immediately. Serious complications include pneumonia, brain inflammation and convulsions and death.
 
Learn more about the signs, symptoms and complications of pertussis infection here.
 
Influenza Vaccine: Limited Effectiveness
 
   “Unfortunately, some people can get infected with the flu virus the flu vaccine is designed to protect against despite getting vaccinated. Protection provided by flu vaccination can vary widely, based in part on health and age factors of the person getting vaccinated.”  – Centers for Diseases Control (2013) [42]
 
According to the CDC, the 2012/2013 influenza vaccine was 9 to 56 percent effective, depending upon the strain, with the elderly receiving little or no protection from the influenza A H3N2 strain. [43]
 
Symptoms of influenza: There are two major influenza types (A and B) and symptoms can include fever, chills, sore throat, fatigue, muscle and body aches, cough, diarrhea and vomiting that can last for more than a week. Serious complications of influenza include dehydration, bacterial ear and sinus infections, bronchitis, pneumonia and death. [44]
 
Learn more about the signs, symptoms and complications of influenza 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. [45] [46] Waning vaccine acquired immunity is thought to be the cause.
 
In 2011-2012, 95% of children entering kindergarten in the U.S. had received two doses of mumps containing (MMR) vaccine [47] and in 2011 about 90% of teenagers had received two doses of mumps containing (MMR) vaccine. [48]
 
Symptoms of mumps infection include fever, headache, muscle aches, fatigue, loss of appetite, swollen and tender salivary glands under the ears on one or both sides that can last for several weeks. Rare complications can include sterility in males. [49]
 
Learn more about the signs, symptoms and complications of mumps 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 infection or complications occur, it is very important to immediately contact a doctor.
 
Learn more about how to recognize vaccine reaction symptoms associated with 17 different infectious diseases for which vaccines have been developed here.
 
 
References:

[2] Nir E. Informed Consent. The Stanford Encyclopedia of Philosophy 2011 (Fall Edition).
 
[3] Shuster E. Fifty Years Later: the Significance of the Nuremberg Code. N Engl J Med 1997; 337: 1436-1440.
 
[4] Evans G, Bostrom A, Johnston RB, Fisher BL, Stoto MA, Editors. Risk Communication and Vaccination: Summary of a Workshop. Vaccine Safety Forum, Institute of Medicine: National Academy Press 1997. Pages 21-22.
 
[6] Fisher BL. The Moral Right to Conscientious, Personal and Philosophical Belief Exemption to Vaccination. National Vaccine Advisory Committee Presentation May 2, 1997. 
 
[7] Science & Environmental Health Network (SEHN). The Wingspread Statement on the Precautionary Principle. January 1998.
 
[8] Pless B. Expanding the precautionary principle. Inj Prev 2003; 9: 1-2.
 
[9] Centers for Disease Control. Smallpox Vaccinations and Adverse Reactions: Guidance for Clinicians. Postvaccinal Central Nervous System Disease. MMWR Feb. 21, 2003; 52(RR04): 1-28. 
 
[10] Miller DL, Ross EM et al.Pertussis Immunization and Serious Acute Neurological Illness in Children. BMJ 1981; 282: 1595-1599.
 
[11] Institute of Medicine Vaccine Safety Committee. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC. The National Academies Press. 1991.
 
[12] Institute of Medicine Vaccine Safety Committee. Adverse Events Association with Childhood Vaccines: Evidence Bearing on Causality. Neurologic Disorders. Washington, D.C. The National Academies Press 1994.
 
[13] Institute of Medicine. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, D.C. The National Academies Press 1994.
 
[15] Kulenkampff M, Schwartzman JS, Wilson J. Neurological complications of Pertussis Vaccination. Arch Dis Child 1974; 46-49.
[16] Stetler HC, Orenstein WA. History of Convulsions and Use of Pertussis Vaccine. J Pediatr 1985; 107(2): 175-179
 
[17] See References #9 – 13.
 
[18] Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press 2012
 
[19] Ibid.
 
[21] Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies. Washington, DC: The National Academies Press 2013.
 
 
[23] Ibid. Conclusions About Scientific Findings. Summary: Pages 10-11.
 
[24] Ibid. Review of Scientific Findings. Chapter 5: Pages 69 - 88.
 
[27] Department of Health & Human Services. Health Resources Services Administration. Vaccine Injury Compensation Program Statistics Report (March 4, 2013)
 
[28] Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9. 
 
[29] Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health.
 
[30] National Vaccine Information Center (NVIC). National Childhood Vaccine Injury Act of 1986.
 
[32] Zimmerman B, Gold R, Lavi S. Adverse effects of immunization: Is prevention possible? Postgrad Med 1987 82(5): 225-229; 232. 
 
[33] CDC. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures Recommendations of the Immunization Practices Advisory Committee (ACIP). Precautions (Warnings). MMWR Aug. 8, 1991; 40(RR10): 1-28.
 
[34]  U.S. Dept. of Health & Human Services. Possible Side Effects from Vaccines: DTaP Side Effects. Vaccines.gov. (Last updated Feb. 13, 2013).
 
[36] CDC. Pertussis (Whooping Cough) – What You Need to Know. (Last updated Feb. 11, 2013). 
[37] CDC. Pertussis (Whooping cough) Infection. (Last updated Feb. 29, 2013)
 
[39] CDC. National and State Vaccine Coverage Among Adolescents Aged 13-17 Years – United States, 2011. MMWR 2012; 61(34): 671-677. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6134a3.htm
 
[41] CDC. Pertussis (Whooping Cough) Signs & Symptoms. (Last updated Feb. 13, 2013).
 
[43] Ibid.
 
[44] CDC. Seasonal Influenza: Flu Symptoms & Severity. (Last updated June 24, 2011).
 
[45] Cortese MM, Jordan HT et al. Mumps Vaccine Performance among University Students During a Mumps Outbreak. Clin Infect Dis 2008; 46(8): 1172-1180.
 
[46] Barskey AE, Glasser JW, LeBaron CW. Mumps resurgence in the United States” A historical perspective on unexpected elements. Vaccine 2009; 27: 6186-6195.
 
[47] See Reference #37.
 
[48] See Reference # 38.
 
[49] CDC. Mumps: Signs & Symptoms of Mumps. (Last updated March 14, 2010)
 



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