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Can Pertussis Vaccine Cause Injury and Death?


The Institute of Medicine has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination.1 However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a DTaP/Tdap vaccine or any other vaccine.

B. pertussis bacteria, which cause pertussis whooping cough disease, and lab altered to make pertussis vaccine, contain several toxins that can cause inflammation in the body. Pertussis toxin (PT) is one of the most lethal toxins in nature and this toxin induces lymphocytosis, leukocytosis, stimulates insulin secretion and sensitizes histamine, which is involved in the immune system’s inflammatory response.2

Pertussis toxin is thought to be the main component of B pertussis bacteria responsible for stimulating the production of protective antibodies during natural whooping cough infection and after pertussis vaccination. Pertussis toxin is also thought to be the main component responsible for causing brain inflammation during B. pertussis whooping cough or after injection of pertussis-containing vaccines.3 4

Since the 1950’s, scientists have injected pertussis toxin into lab animals whenever they want to deliberately induce histamine, serotonin and endotoxin sensitivity or experimental autoimmune encephalomyelitis.5 6 7 Because pertussis toxin can cross the blood brain barrier when conditions are right, brain inflammation (encephalitis) that causes permanent brain damage has always been the most dreaded serious complication of both whooping cough and pertussis vaccination.

Another toxin produced by B. pertussis bacteria during natural infection is endotoxin, which is also present in pertussis vaccines in varying amounts. When the immune system detects the presence of endotoxins, it produces a defensive inflammatory immune response, including the release of large amounts of histamine that can, under certain circumstances, lead to high fever, swelling, diarrhea, collapse, shock and death.8

The whole cell pertussis component of the DPT vaccine, the original pertussis containing vaccine in widespread use from 1949 until the late 1990’s, was found to be highly reactive, causing brain inflammation and encephalopathy.9 10 11

The authors of the 1981 British National Childhood Encephalopathy Study (NCES)12 noted in 1993,13 and the Institute of Medicine confirmed in 1994,14 that brain inflammation and encephalopathy is associated with a broad range of long term brain dysfunction that affects the physical, social, behavioral and educational outcomes for children. Signs of brain inflammation in infants or very young children can include high fever; irritability; vomiting; high pitched screaming (encephalitic cry) with or without arching of back; prolonged, uncontrollable crying; collapse and unresponsiveness with pale skin and blue lips; crossing or wandering eyes; drowsiness/lethargy; convulsions (seizures) with or without fever; regression and loss of developmental milestones and negative changes in mental, emotional and physical health. Death or a diagnosis of mental retardation, medication resistant seizure disorders, learning disabilities, attention deficit disorder, autism and other chronic neurological and health problems may follow an acute brain inflammation.15

In 1991, the Institute of Medicine (IOM), National Academy of Sciences, published the first of four reports of expert committees, which reviewed the medical literature for evidence that vaccines can cause injury and death.16 The literature review was mandated under the National Childhood Vaccine Injury Act of 1986. The 1991 IOM report on Adverse Effects of Pertussis and Rubella Vaccines17 concluded that “evidence is consistent with a causal relation between DPT vaccine and acute encephalopathy (brain inflammation) and “unusual shock-like state”18 (hypotonic/hyporesponsive episode): and that “evidence indicates a causal relation between DPT vaccine and shock (anaphylaxis) and protracted, inconsolable crying.”19

In 1994, the IOM published the report DPT Vaccine and Chronic Nervous System Dysfunction 20 after reviewing the 10-year follow up the British NCES study and concluded that “NCES data are consistent with the possibility that some children without underlying brain or metabolic abnormalities might experience serious acute neurologic illness within 7 days after receiving DPT and that acute illness could have chronic nervous system sequelae. The NCES data also are consistent with the possibility that some children with underlying brain or metabolic abnormalities (which foster a “triggering” by DPT of an acute neurologic illness) might go on to develop chronic nervous system dysfunction due to a DPT-triggered acute illness. Therefore the committee concludes that the balance of evidence is consistent with a causal relation between DPT and the forms of chronic nervous system dysfunction described in NCES in those children who experience a serious acute neurologic illness within 7 days after receiving DPT vaccine. This serious neurologic risk is a rare event. The estimated excess risk ranged from 0 to 10.5 per million immunizations.”21

Between 50 and 80 percent of babies who received the whole cell DPT vaccine ran fevers, and experienced pain, redness and swelling at the site of the injection, and many of them were fussier or lost their appetite for a day or two. 22 Published research also concluded that the whole cell pertussis vaccine had the ability to cause far more serious reactions such as high-pitched screaming,23 hypotonic/hyporesponsive episodes, 24 febrile or afebrile convulsions, 25 26 and brain inflammation (also known as encephalitis, encephalomyelitis and encephalopathy). 27 28 29 Between 25 and 60 percent of children who develop acute encephalitis or encephalopathy or have convulsions, including febrile convulsions - for any reason - are left with personality changes, developmental delays, learning disabilities, ADHD, seizure disorders, lower IQ, speech, motor and behavior disorders and other disabilities. 30 31 32 33 34

A 1981 U.S. study funded by the FDA and conducted at UCLA found that convulsion or collapse/shock occurred as frequently as 1 in every 875 DPT shots.35 As well, some of the children who participated in this study were left with neurological problems and low IQs. The 1981 British National Childhood Encephalopathy Study (NCES) estimated that the risk of a previously healthy child developing a serious neurological problem within seven days of DPT vaccination was 1 in 110,000 DPT shots and the risk of chronic brain dysfunction was 1 in 310,000 DPT shots. 36 Again, some of the children involved in the study were left with brain damage manifested by “neurologic, motor, sensory, educational behavioral and self-care dysfunctions.” 37

While a “safer” acellular pertussis vaccine (DTaP) was available and in wide-spread use in Japan by 1981, the FDA did not approve this vaccine until 1991, and only as an option for young children over the ages of 15 months to 6 years of age following administration of three doses of the whole cell DPT vaccine.38 It was 1996 before the FDA approved the DTaP vaccine for administration in infants and children 6 weeks to 6 years of age39 and 1997 before the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the DTaP vaccine in lieu of the highly reactive whole cell DPT vaccine.40

The current acellular pertussis vaccine (DTaP/Tdap) vaccines still contain chemically inactivated pertussis toxin (10-25 mcg per dose) that retain varying amounts of bioactivity, which may induce brain inflammation in some individuals. Chiron, a company producing a genetically engineered DTaP vaccine in the early 1990’s, explained that one reason why chemically inactivated pertussis toxin will be a problem for some: “Genetic detoxification ensures than no active form of the pertussis toxin is present, while chemically detoxified pertussis toxins may revert to toxicity.”41

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, published in 2012 by the Institute of Medicine, 26 reported vaccine adverse events following DTaP/Tdap vaccine were evaluated by a physician committee.42 These adverse events included encephalopathy, encephalitis, chronic urticarial, autism, serum sickness, SIDS, arthritis, Guillain Barre Syndrome, diabetes mellitus, immune thrombocytopenic purpura, transverse myelitis and more.

In 24 of the 26 DTaP/Tdap vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the DTaP/Tdap vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.43 The IOM committee concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and DTaP/Tdap vaccine.44 However, based on the evaluation of five epidemiological studies, the committee concluded that scientific evidence “favors rejection” of a relationship between Diabetes Type 1 and DTaP/Tdap vaccine.45

Most pediatric neurologists acknowledge that vaccination, including use of vaccines for smallpox, rabies, influenza, mumps, measles, tetanus, polio and pertussis, can and does occasionally cause neurological complications that can lead to permanent brain dysfunction.46

Additional Reported Complications:

  • Allergic hypersensitive reactions occurring within minutes or hours of vaccination. These may include hives, sudden swelling of the mouth or throat, difficulty breathing, hypertension and shock.47 48
  • Thrombocytopenia and Hemolytic Anemia are two blood disorders, which have been reported to rarely follow pertussis vaccine containing shots.49 50Thrombocytopenia means a reduced number of platelets circulating in the blood and can cause "purpura" (blotchy red patches on the child’s body caused by the thinned blood seeping into the tissues beneath the skin).51
  • Diabetes and Hypoglycemia – The body’s glucose (sugar) metabolism is regulated by insulin, which is secreted by the pancreas. Researchers have detected increased insulin production in infants injected with pertussis vaccine.
      • In 1970, Pittman stated "the infant whose blood sugar level is influenced by food intake may be especially vulnerable to vaccine-induced hypoglycemia should a feeding be missed because of a feverish reaction following vaccinations."52
      • Hannik and Cohen in 1978 concluded, "infants who show serious reactions following pertussis vaccination suffer from failure to maintain glucose homeostasis."53
      • A 1982 study detailed the role the DPT vaccine played in causing diabetes in a 16-month old girl who was genetically predisposed to diabetes and who suffered from a viral infection that attacked her pancreas.54

The Pertussis Vaccine, Death, and SIDS

Death was the first reaction to be associated with pertussis vaccine. In 1933, the Danish vaccine researcher Madsen described the deaths of two babies within a few hours after they had been vaccinated.55

It is not known how many pertussis vaccine-related deaths occur in the US each year because sometimes the deaths of babies, who die after experiencing symptoms of reactions to DTaP, are misclassified as SIDS. Sudden Infant Death Syndrome (SIDS). SIDS usually involves the sudden, unexplained death of an infant, where there are no symptoms of any health problems before the baby is found lifeless.

Babies, who die after exhibiting pertussis vaccine reaction symptoms (such as high pitched screaming, collapse, extreme lethargy, convulsions) do not fit the general criteria of SIDS but are rarely reported as vaccine-related deaths. 56 57 58

Reported Pertussis vaccine reactions

Using the MedAlerts search engine, as of June 30, 2018 there had been 150,043 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pertussis-containing vaccines since 1990. Half of those serious pertussis vaccine-related adverse events occurred in children under the age of three. Of these pertussis-vaccine related adverse event reports to VAERS, 2,745 were deaths, with over 90% of the deaths occurring in children under three years of age.

However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after pertussis vaccination.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations. 59 60 61 62 63

As of August 8, 2018, there had been 5,369 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following pertussis-containing vaccination, including 862 deaths and 4507 serious injuries. The DPT vaccine is the vaccine with the most injury claims filed, including for death, and it is the second most compensated vaccine injury claim, with influenza vaccine now in first place. 64

How to Recognize a Pertussis Vaccine Reaction

It cannot be emphasized enough that parents should monitor their children carefully day and night for at least 72 hours after vaccination.65 The first 24-hour post-vaccination is an especially important time to be alert. Although identifying a severe vaccine reaction is the shared responsibility of parents and doctors, only parents can be with a child 24 hours a day.

Many children react to pertussis containing vaccines and recover without any apparent effects while others are left with chronic health problems. It is important to know how to recognize a potential vaccine reaction and to seek medical attention immediately if you suspect your child is suffering a severe vaccine reaction, such as unresponsiveness, convulsion (seizure), high pitched screaming (encephalitic cry) or other signs of brain inflammation.66

Pertussis vaccine has been documented to cause high fever; severe local reactions at the site of the injection67 68; high pitched screaming and uncontrollable crying69 70; collapse/shock (hypotonic/hyporesponsive episode) 71; lethargy (excessive sleepiness); convulsions with or without fever 72 73 74 75 76; and brain inflammation (encephalopathy).77 78 79 80 81 82 83

It is important for parents to know what constitutes a severe reaction to a pertussis vaccine containing shot because it is generally agreed by vaccine policy makers that those who react severely should not receive the "P" or pertussis portion of the DPT, DTaP or Tdap shot again. For subsequent boosters, only the "D" (diphtheria) and "T" (tetanus) portion of the shot should be administered.84

Following are descriptions of more serious vaccine reactions symptoms in the words of parents:

  • Collapse/Shock: “She turned white with a blue tinge around her mouth and went completely limp.”
  • Convulsion: “Her eyes twitched, her chin trembled, her body went rigid and then would shake.”
  • Behavior Changes: “She won’t sleep or eat. She throws herself down and screams for no reason. She was sweet and happy and is now out of control. She changed into a totally different child.”
  • High Fever: “His temperature was 105 degrees. I had to put cool towels on him to bring the fever down.”
  • Injection Site: “There was a big, hot swollen lump at the site of the shot that stayed for weeks.”
  • High Pitched Screaming: “It was a pain cry, a shrill scream and lasted for hours and nothing would help.”
  • Excessive Sleepiness: “He passed out and we couldn’t wake him to feed or do anything for over 12 hours.”
  • Brain Inflammation: “He just laid in his crib with his eyes wide open, then would arch his back and scream and go unconscious. Now he has seizures.”
  • Regression: “My 18 month old son stopped talking and walking after those shots. He developed severe allergies, constant diarrhea, ear infections and was sick all the time.”

If your child exhibits one or more of these symptoms or other dramatic change in physical, mental or emotional health/behavior within hours, days or weeks after vaccination, you should immediately have your child examined by your physician or go to the emergency room of your local hospital.

Make sure the date and time of the vaccination and the symptoms your child is having are recorded in your child’s medical record and that you do not leave the office or hospital without a written medical record that your child has been examined.

You can request that medical personnel make a formal vaccine adverse event report to the federal Vaccine Adverse Event Reporting System (VAERS).85 If a doctor or medical worker will not make a vaccine reaction report to the government, you can make a report yourself.86

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

« Return to Vaccines & Diseases Table of Contents

References

1 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality: Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.

2 Finger H, von Koenig CHW. Chapter 31 Bordetella. Medical Microbiology. 4th edition. Galveston (TX): University of Texas Medical Branch at Galveston; 1996.

3 Geier DA, Geier MR. Clinical Implications of Endotoxin Content in Vaccines. Ann Pharmacother 2002; 36(5).

4 Brito LA, Singh M. Acceptable Levels of Endotoxin in Vaccine Formulations During Preclinical Research. J. Pharm. Sci 2011; 100(1): 34-37.

5 Changming L, Pelech S et al. Pertussis toxin induces angiogenesis in brain microvascular endothelial cells. J Neuroscience Research 2008; 86(12): 2624-2640.

6 Linthicum DS. Development of acute autoimmune encephalomyelitis in mice: factors regulating the effector phase of the disease. Immunobiology 1982; 162(3): 211-220.

7 Sidey FM, Furman BL, Wardlaw AC. Effect of hyperreactivity to endotoxin on the toxicity of pertussis vaccine and pertussis toxin in mice. Vaccine 1989; 7(3): 237-241.

8 Bannatyne RM, Cheung R. Reducing the endotoxic activity of pertussis vaccine. J Hyg (Lond). 1981 Dec; 87(3): 377–381.

9 Globus, JH, Kohn JL Encephalopathy following pertussis vaccine prophylaxis. JAMA 1949;141(8):507-509.

10  Berg JM, Neurological complications of pertussis immunization. Br Med J. 1958 Jul 5; 2(5087): 24–27.

11 Cavanagh NP, Brett EM. et al. The possible adjuvant role of bordetella pertussis and pertussis vaccine in causing severe encephalopathic illness: a presentation of three case histories. Neuropediatrics. 1981 Nov;12(4):374-81.

12 Miller DL, Ross EM et al. Pertussis immunisation and serious acute neurological illness in children. Br Med J (Clin Res Ed). 1981 May 16;282(6276):1595-9.

13 Miller D, Madge N et al Pertussis immunisation and serious acute neurological illnesses in children. BMJ. 1993 Nov 6; 307(6913): 1171–1176.

14 Institutes of Medicine. DPT Vaccine and Chronic Nervous Dysfunction: A New Analysis. Washington, DC. The National Academy Press. 1994

15 Ibid

16 Institute of Medicine. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC. The National Academies Press. 1991

17 Ibid

18 Ibid

19 Ibid

20 Institutes of Medicine. DPT Vaccine and Chronic Nervous Dysfunction: A New Analysis. Washington, DC. The National Academy Press. 1994

21 Ibid

22 Barkin RM, Pichichero ME. Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products. Pediatrics 1979; 63(2): 256-260.

23 Neuroimmunolgy Clinic, KK Women’s and Children’s Hospital. Encephalitis in Children: Symptoms, Complications and Treatment. Health Xchange 2016.

24 DuVernoy TS, Braun MM, the VAERS Study Group. Hypotonic-Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998Pediatrics 2000; 106(4).

25 Wheless JW, Sirven JI. Seizures in NewbornsEpilepsy Foundation Aug. 27, 2013.

26  Duffy J, Weintraub E et al. Febrile Seizure Risk After Vaccination in Children 6 to 23 Months. Pediatrics 2016; 138(1).

27  Menkes JH, Kinsbourne M. Workshop on Neurologic Complications of Pertussis and Pertussis Vaccination. Neuropediatrics 1990; 21(4): 171-176.

28 HRSA. Encephalopathy, Encephalitis, Acute Dissemination Encephalomyelitis. Vaccine Injury Compensation Program Vaccine Injury Table. Mar. 21, 2017.

29 Pellegrino P, Carnovale C, Perrone V et al. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting SystemPLOS One Oct. 18, 2013.

30 Wolf SM, Forsythe A. Epilepsy and mental retardation following febrile seizures in childhood. Acta Pediatr Scand 1989; 78(2): 291-295.

31 MacDonald BK, Johnson AL et al. Febrile convulsions in 220 children – neurological sequelae at 12 years follow-up. Eur Neurol 1999; 41(4): 179-186.

32 LaRoche SM. Seizures and EncephalopathySemin Neurol 2011; 31(19): 194-201.

33 Rao S, Elkon B et al. Long-Term Outcomes and Risk Factors Associated with Acute Encephalitis in ChildrenJ Ped Infect Dis Soc 2015; 1(1): 20-27.

34 Burton KLO, Williams TA et al. Long-Term Neuropsychological Outcomes of Childhood Onset Acute Disseminated Encephalomyelitis (ADEM): A Meta-AnalysisNeuropsychology Rev 2017; 27(2): 124-133.

35 Cody CL, Baraff LJ, Cherry JD et al. Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children. Pediatrics 1981; 68(5).

36 Miller DL, Ross EM et al. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1981; 282:1595-9.

37 Institute of Medicine Committee to Study New Research on Vaccines. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Executive Summary (pp.1-2) Washington, D.C. The National Academies Press 1994.

38 CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Mar. 28, 1997;46(RR-7):1–25

39 Ibid

40 CDC Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR. Mar. 24, 2006. 55(RR03);1-34

41 The Free Library. S.v. CHIRON BIOCINE GENETICALLY ENGINEERED ACELLULAR PERTUSSIS VACCINE PROVES SUPERIOR TO CURRENTLY LICENSED VACCINE.." Retrieved Aug 17 2018 fromhttps://www.thefreelibrary.com/CHIRON+BIOCINE+GENETICALLY+ENGINEERED+ACELLULAR+PERTUSSIS+VACCINE...-a017247344

42 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012

43 Ibid

44 Ibid

45 Ibid

46 Bale JF Jr. Neurologic complications of immunization. J Child Neurol. 2004 Jun;19(6):405-12.

47 U.S. National Library of Medicine. Anaphylaxis (Anaphylactic Shock). MedLine Plus.

48 CDC. Preventing and Managing Adverse Vaccine Reactions.  Feb. 21, 2018.

49 Bhowmik A, Biswas T. Immune Thrombocytopenia Following Diphtheria Pertussis- Tetanus and Oral Polio Vaccine. Indian Pediatr. 2016 Oct 8;53(10):934-935.

50 O'Leary ST, Glanz JM et al. The risk of immune thrombocytopenic purpura after vaccination in children and adolescents. Pediatrics. 2012 Feb;129(2):248-55.

51 Martel J. Low Platelet Count (Thrombocytopenia) Healthline. Feb. 8, 2016

52 Pittman, M.  Bordetella pertussis – Bacterial and host factors in the pathogenesis and prevention of whooping cough. In S. Mudd, ed. Infectious agents and host reactions: 1970. Philadelphia: W.B. Saunders, 239-70.

53 Hannik, C.A., Cohen, H. Changes in plasma insulin concentration and temperature of infants after pertussis vaccination. International Symposium on Pertussis,1978. 297-99.

54 Champsaur H et al. 1982. Virologic, immunologic, and genetic factors in insulin dependent diabetes mellitus. Pediatrics 1982.100(1):15-20.

55 Madsen, T. Vaccination against whooping cough. JAMA. 1933 101(3):187-88.

56 Baraff LJ, Ablon WJ, Weiss RC. Possible temporal association between diphtheria-tetanus toxoid-pertussis-vaccination and sudden infant death syndrome. Pediatr Infect Dis. 1983 Jan-Feb;2(1):7-11.

57 Gerathy KC. DPT Immunization and SIDS. Pediatrics 1984 105:169-170.

58 Torch WC. 1982. Diptheria-pertussis-tetanus (DPT) immunization: A potential cause of sudden infant death syndrome (SIDS), American Academy of Neurology, 34th Annual Meeting, 1982. April25-May1. Neurology 32(4):pt. 2.

59 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.

60 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.

61 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health

62 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.

63 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010

64 HRSA. Vaccine Injury Compensation Program (VICP) Data & Statistics. Aug. 31, 2018.

65 Institute of Medicine Committee to Study New Research on Vaccines. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Executive Summary (pp.1-2) Washington, D.C. The National Academies Press 1994.

66 NVIC. Do You Know How to Recognize a Vaccine Reaction? Aug 27, 2018

67 Pineau A, Durand C et al. Role of aluminum in skin reactions after diphtheria-tetanus-pertussis-poliomyelitis vaccination: an experimental study in rabbits. Toxocology 1992; 73(1): 117-125.

68 Pichichero ME, Edwards KM et al. Safety and Immunogenicity of Six Acellular Pertussis Vaccines and One Whole-Cell Pertussis Vaccine Given as a Fifth Dose in Four to Six Year old Children. Pediatrics 2000; 105(1).

69 Markel H, Oski JA et al. The Crying Infant. In: The Portable Pediatrician 1992; pp.70-72.

70 Neuroimmunolgy Clinic, KK Women’s and Children’s Hospital. Encephalitis in Children: Symptoms, Complications and Treatment. Health Xchange 2016.

71 DuVernoy TS, Braun MM, the VAERS Study Group. Hypotonic-Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics 2000; 106(4).

72 Wheless JW, Sirven JI. Seizures in NewbornsEpilepsy Foundation Aug. 27, 2013.

73 Sun Y, Christensen J et al. Risk of febrile seizures and epilepsy after vaccination with diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B. JAMA 2012; 307(8): 523-531.

74 Duffy J, Weintraub E et al. Febrile Seizure Risk After Vaccination in Children 6 to 23 Months. Pediatrics 2016; 138(1).

75 Wolf SM, Forsythe A. Epilepsy and mental retardation following febrile seizures in childhood. Acta Pediatr Scand 1989; 78(2): 291-295.

76 MacDonald BK, Johnson AL et al. Febrile convulsions in 220 children – neurological sequelae at 12 years follow-up. Eur Neurol 1999; 41(4): 179-186.

77 LaRoche SM. Seizures and EncephalopathySemin Neurol 2011; 31(19): 194-201.

78 HRSA. Encephalopathy, Encephalitis, Acute Dissemination Encephalomyelitis. Vaccine Injury Compensation Program Vaccine Injury Table. Mar. 21, 2017.

79 Pellegrino P, Carnovale C, Perrone V et al. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting System. PLOS One Oct. 18, 2013.

80 Rao S, Elkon B et al. Long-Term Outcomes and Risk Factors Associated with Acute Encephalitis in Children. J Ped Infect Dis Soc 2015; 1(1): 20-27.

81  Iro MA, Sadarangani M et al. Immunoglobulin in the Treatment of Encephalitis (IgNiTE): protocol for a multicenter randomized controlled trial. BMJ Open 2016; 6(11).

82 Burton KLO, Williams TA et al. Long-Term Neuropsychological Outcomes of Childhood Onset Acute Disseminated Encephalomyelitis (ADEM): A Meta-Analysis. Neuropsychology Rev 2017; 27(2): 124-133.

83 Institute of Medicine Committee to Study New Research on Vaccines. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Executive Summary (pp.1-2) Washington, D.C. The National Academies Press 1994.

84 CDC DTaP (Diphtheria, Tetanus, Pertussis) VIS - Some children should not get DTaP vaccine or should wait. Aug. 24, 2018

85 NVIC. Report Vaccine Reactions: It’s the Law!

86 DHHS. Vaccine Adverse Event Reporting System (VAERS). Two Ways to Submit an Online Report to VAERS. Also Online VAERS Reporting Demonstration. July 2017.


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