April 14, 2020

Read the Fine Print: Vaccine Package Inserts Reveal Hundreds of Medical Conditions Linked to Vaccines

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By the Children’s Health Defense Team

 

In March 2015, Dr. Anthony Fauci—the career National Institutes of Health official elevated by the media to the status of COVID-19 Grand Poobah—told PBS’s Frontline with a straight face that risks from vaccines are “almost nonmeasurable.” Fauci then proceeded to downplay every potential vaccine risk proposed by the interviewer, stating that each had “no basis in reality.” Having served at the helm of the National Institute of Allergy and Infectious Diseases (NIAID) since 1984, Fauci surely was aware then, and is aware now, that the National Vaccine Injury Compensation Program established in the late 1980s has paid out billions of dollars to the vaccine-injured: $4.3 billion as of April 1, 2020. Did Fauci feel that he could get away with making such dismissive statements because he knew about the Harvard study from 2010 showing that fewer than 1% of vaccine adverse events get reported—and what isn’t reported can’t be measured?

All package inserts (made available online by both the FDA and vaccine companies) contain a section on Postmarketing Experience (Section 6.2) that lists adverse events “spontaneously reported in the US and other countries” after the vaccine’s licensure.

Vaccines belong to the class of pharmaceutical products called biologics, products that allergy experts widely recognize for their “potential to cause allergic hypersensitivity reactions,” among other adverse effects. Is Dr. Fauci—director of an institution focused on allergies and immunology—unaware that the package inserts of at least 22 vaccines list allergic hypersensitivity reactions as an adverse event, and that the inserts of at least 31 vaccines list post-vaccine anaphylactic reactions?

The fact is that vaccine package inserts are one of the few available sources of detailed information that consumers can turn to when they want to sidestep official stonewalling and learn about the more than 200 adverse events reported for vaccines given to children and adolescents. All package inserts (made available online by both the FDA and vaccine companies) contain a section on Postmarketing Experience (Section 6.2) that lists adverse events “spontaneously reported in the US and other countries” after the vaccine’s licensure. Manufacturers include adverse events in the list on the basis of severity, frequency of reporting and strength of evidence for a causal relationship to the vaccine. They also include adverse events that may not have been detected during the vaccine’s clinical trials.

… vaccines—promoted for the prevention of 13 illnesses—have yielded postmarketing reports of at least 217 adverse medical outcomes, including death.

Shining a light on the fine print

To facilitate parents’ use of the information buried in small print in the package inserts, Children’s Health Defense has conducted a comprehensive review of the adverse events reported in Section 6.2 for all vaccines currently included in the U.S. childhood and adolescent vaccine schedule. The review includes 38 vaccine brands produced by 8 different manufacturers to protect against diphtheria, Haemophilus influenzae type b, hepatitis A, hepatitis B, human papillomavirus, influenza, meningococcal infection, pertussis, pneumococcal infection, polio, rotavirus, tetanus and varicella (Table 1). According to the information compiled from the inserts, these vaccines—promoted for the prevention of 13 illnesses—have yielded postmarketing reports of at least 217 adverse medical outcomes, including death (Table 2).

There are several things to note about the information presented in Table 2. First, while we used the verbatim insert terminology for each disorder and also largely stuck to the disease groupings in the package inserts, we added two categories—allergic and autoimmune disorders—that the inserts surprisingly omit. (The package inserts lump allergic reactions in with “immune system disorders.”) Second, there are a number of disorders that fit in more than one category; in those instances, we have included them (with an asterisk*) in both places (while counting them once). Third, the table only includes those adverse events that manufacturers decided to report in the inserts—but other adverse events are not only possible but likely, due to the widespread problem of underreporting. Notably, none of the package inserts include any mention of prevalent, childhood-onset neurodevelopmental disorders like tics or autism that published, peer-reviewed studies have linked to vaccines.

…the Pentacel vaccine (which contains a Hib component) can produce “invasive Hib disease”; the RotaTeq vaccine (for rotavirus) is associated with “transmission of vaccine virus strains to the unvaccinated”; and some influenza vaccines trigger influenza.

Themes

As readers peruse Table 2, they may notice the following themes:

  • Every single vaccine on the childhood/adolescent vaccine schedule is responsible for at least one adverse event. For example, as already noted, roughly four out of five vaccines (82%) are associated with reports of anaphylactic reactions. The incidence of anaphylaxis has been climbing in the U.S. for several decades. Medications are the top known triggers of anaphylaxis, while another 39% of anaphylaxis cases are idiopathic, meaning that the cause is “unknown.”
  • Vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent. In the era of measles hype and hysteria, it is particularly important to point out that both MMR vaccines—MMR-II and ProQuad—are failing to prevent “atypical measles” (both vaccines), “measles” (ProQuad), “measles-like rash” (MMR-II) and “skin infections” (ProQuad). Likewise, the package inserts report “varicella” and “varicella-like rash” in the aftermath of vaccination with Varivax and ProQuad (which combines varicella with MMR). Equally concerning, the MMR-II and ProQuad vaccines—which have shifted mumps from a noneventful childhood illness to a fertility-endangering condition afflicting adolescents and adults—have produced reports of serious testicular problems (epididymitis and orchitis). Table 2 also shows that the Pentacel vaccine (which contains a Hib component) can produce “invasive Hib disease”; the RotaTeq vaccine (for rotavirus) is associated with “transmission of vaccine virus strains to the unvaccinated”; and some influenza vaccines trigger influenza.
  • Vaccines can also cause other serious infections. For example, the risky MMR-II, ProQuad and Varivax trio is linked to “pneumonia” and “pulmonary congestion,” the Infanrix and Pediarix vaccines are associated with “respiratory tract infections” and seven different vaccines are associated with various forms of meningitis. Ironically (or perhaps not), pneumonia and meningitis are the targets of the pneumococcal and meningococcal vaccines.
  • Vaccine adverse events affect numerous body systems, including the immune and nervous systems. Although the longest list of adverse impacts—41—is for effects on the nervous system, the wide-ranging list also shows effects on the blood, connective tissue, ears, eyes, gastrointestinal system, heart, liver, lymph nodes, musculoskeletal system, respiratory system, skin and more.
Dr. Fauci himself might want to take note of the fact that companies like Johnson & Johnson, one of those rushing to develop a coronavirus vaccine, have been censured by the Department of Justice for drug marketing fraud that exposed children and the elderly to serious side effects, including death.

Measurable and often unsafe

All pharmaceutical products come with potential side effects, and vaccines are no exception. For Dr. Fauci to describe the adverse events associated with vaccines as “almost nonmeasurable”—when they are not only described in package inserts but tracked in postmarketing surveillance systems such as the U.S. Vaccine Adverse Event Reporting System (VAERS), the European EudraVigilance system and the World Health Organization’s VigiBase system—is not only disingenuous but unethical. Given that Dr. Fauci’s wife is a senior NIH bioethicist, the NIAID director’s ethically murky eagerness to deemphasize the prevalence and significance of vaccine adverse events is surprising.

As the COVID-19 situation has brought Fauci into the limelight as “explainer-in-chief” of the epidemic—and proponent-in-chief of patentable vaccines that will use untested technologies while leapfrogging over ordinary vaccine development protocols—we would do well to query Fauci’s five-year-old throwaway remarks about vaccine safety. Dr. Fauci himself might want to take note of the fact that companies like Johnson & Johnson, one of those rushing to develop a coronavirus vaccine, have been censured by the Department of Justice for drug marketing fraud that exposed children and the elderly to “serious side effects, including death.”

Much has been made of Fauci’s, NIAID’s and the NIH’s cozy entanglements with Bill Gates, the Bill & Melinda Gates Foundation and the Gates-Foundation-created Coalition for Epidemic Preparedness Innovations (CEPI), particularly in light of the massive Gates Foundation and CEPI funding being directed toward coronavirus vaccines that the NIH is also supporting. Gates recently called for digital “certificates” showing who has received an eventual coronavirus vaccine and also made veiled statements that “you don’t want people moving around the world” unless they have received a vaccine. In that context, Fauci’s additional remarks in the 2015 Frontline interview take on somewhat ominous overtones. The good doctor stated that while “there’s never a situation where someone is going to tie you down and vaccinate you . . . you don’t want the respect for autonomy of people to get in the way of a public health mandate.” 

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Table 1. Vaccine package inserts reviewed

Type of Vaccine Brand Name Manufacturer
Vaccines containing diphtheria, tetanus and pertussis components Adacel (Tdap)
Boostrix (Tdap)
Daptacel (DTaP)
Diphtheria and Tetanus Toxoids Adsorbed (DT)
Infanrix (DTaP)
Kinrix (DTaP-IPV)
Pediarix (DTaP-HepB-IPV)
Pentacel (DTaP-IPV/Hib)
Quadracel (DTaP-IPV)
Tdvax (Td)
Tenivac (Td)
Sanofi Pasteur
GlaxoSmithKline (GSK)
Sanofi
Sanofi
GSK
GSK
GSK
Sanofi
Sanofi
MassBiologics
Sanofi
Haemophilus influenzae type b vaccines ActHIB (Hib)
Hiberix (Hib)
PedvaxHIB (Hib)
Sanofi
GSK
Merck
Hepatitis vaccines Engerix-B (HepB)
Havrix (HepA)
Recombivax HB (HepB)
Twinrix (HepA/HepB)
Vaqta (HepA)
GSK
GSK
Merck
GSK
Merck
Human papillomavirus (HPV) vaccines Gardasil
Gardasil 9
Merck
Merck
Influenza vaccines Afluria Quadrivalent
Fluarix
Flublok Quadrivalent (age 18 and older)
Flucelvax
Flulaval Quadrivalent
FluMist
Fluzone Quadrivalent
Sequirus
GSK
Protein Sciences Corporation
Sequirus
GSK
AstraZeneca
Sanofi
Meningococcal vaccines Bexero
Trumenba
GSK
Pfizer
Measles-mumps-rubella (MMR) and MMR+varicella vaccines MMR-II (MMR)
Proquad (MMRV)
Merck
Merck
Pneumococcal vaccines Prevnar-13
Pneumovax-23
Pfizer
Merck
Inactivated polio vaccine (IPV) IPOL (IPV) Sanofi
Rotavirus vaccines Rotarix
RotaTeq
GSK
Merck
Varicella vaccine Varivax Merck

Table 2. Adverse events reported in package inserts, by body system*

[Note: Medical conditions with asterisks appear in more than one category.]
Body System Medical Disorder Vaccines Reporting Disorder
Allergic (5) Allergic reactions/hypersensitivity* ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix
Anaphylactic and anaphylactoid reactions, including shock* ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax
Angioedema* ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, RotaTeq, Tenivac, Twinrix, Varivax
Serum sickness* Afluria, Engerix-B, Fluarix, Havrix, Pneumovax-23, Recombivax, Twinrix
Urticaria* [hives] ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix
Autoimmune (7) Diabetes mellitus* MMR-II
Guillain-Barré syndrome* Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax
Kawasaki disease* [blood vessel disease] Rotarix, RotaTeq
Lupus-like syndrome* Recombivax
Multiple sclerosis (or MS exacerbation)* Engerix-B, Havrix, Recombivax, Twinrix
Pancreatitis* Gardasil/Gardasil 9, MMR-II
Systemic lupus erythematosus* Recombivax
Blood/lymphatic system (10) Anemia, aplasic or hemolytic Gardasil/Gardasil 9, Pneumovax-23, ProQuad, Varivax
Epistaxis [nosebleed] FluMist, ProQuad
Extravasation [blood vessel leakage] ProQuad
Hematochezia [bloody stools] ProQuad, Rotarix, RotaTeq
Increased erythrocyte sedimentation rate Recombivax
Leukocytosis [increased white blood cells] MMR-II, Pneumovax-23
Lymphadenitis [swollen lymph nodes] Boostrix, Pneumovax-23, ProQuad
Lymphadenopathy, including regional Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, IPOL, Kinrix, MMR-II, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Tenivac
Thrombocytopenia [low platelets] Afluria, Engerix-B, Fluzone, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax
Thrombocytopenic purpura, idiopathic Gardasil/Gardasil 9, Rotarix, Twinrix, Varivax
Cardiac (6) Cyanosis* [bluish discoloration, low oxygen] Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel
Hypotension Adacel
Myocarditis [heart muscle inflammation] Adacel, Boostrix
Palpitations Engerix-B, Twinrix
Pericarditis [pericardial inflammation] FluMist
Tachycardia [abnormally high heart rate] Engerix-B, Fluarix, Recombivax, Twinrix
Congenital (1) Congenital anomaly Havrix
Death (2) Death Gardasil/Gardasil 9, MMR-II, Rotarix, RotaTeq
Sudden Infant Death Syndrome (SIDS) Infanrix
Ear/labyrinth (5) Ear pain Engerix-B, Infanrix, ProQuad, Twinrix
Nerve deafness MMR-II, ProQuad
Otitis media MMR-II
Tinnitis Engerix-B, Recombivax, Twinrix
Vertigo Engerix-B, Fluarix
Eye (15) Conjunctivitis Engerix-B, Fluarix, MMR-II, Recombivax, Twinrix
Eye irritation Fluarix, ProQuad
Eye pain Fluarix, Flulaval
Eye redness Fluarix
Eye swelling Bexero, Fluarix
Eyelid swelling Fluarix, ProQuad
Keratitis [corneal inflammation] Engerix-B
Ocular hyperemia [eye inflammation] Fluzone
Ocular palsies* [nerve damage] MMR-II, ProQuad
Optic neuritis/neuropathy, papillitis* [inflammation of optic nerve] Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix
Photophobia [light intolerance] Flulaval
Retinitis, necrotizing [inflammation] MMR-II, ProQuad, Varivax
Retrobulbar neuritis [nerve damage] MMR-II, ProQuad
Uveitis [eye inflammation] Recombivax
Visual disturbances Engerix-B, Recombivax, Twinrix
Gastrointestinal (13) Abdominal pain, discomfort Fluarix, ProQuad
Candidiasis* ProQuad
Constipation Recombivax
Diarrhea Daptacel, FluMist, MMR-II, Pediarix, Pentacel
Dyspepsia [indigestion] Engerix-B, Twinrix
Dysphagia [swallowing difficulties] Flulaval
Gastroenteritis Rotarix, RotaTeq
Intussusception, including recurrent/fatal Rotarix, RotaTeq
Mouth ulcers ProQuad
Nausea Daptacel, DT, Fluarix, FluMist, Gardasil/Gardasil 9, MMR-II, Pneumovax-23, Tdvax
Pancreatitis* Gardasil/Gardasil 9, MMR-II
Swelling of mouth, throat or tongue Fluarix
Vomiting Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, MMR-II, Pediarix, Pentacel, Pneumovax-23, Tenivac
General and injection site (20) Abnormal gait Flulaval
Apathy ProQuad
Asthenia [fatigue, weakness] Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, Pediarix, Tenivac
Body aches Fluarix
Chest pain Fluarix, Flulaval, Fluzone
Chills Fluarix, Gardasil/Gardasil 9, Havrix, Twinrix
Decreased limb mobility Pneumovax-23
Feeling hot Fluarix
Fever MMR-II, Pneumovax-23
Injected limb—extensive swelling ActHIB, Bexero, Hiberix
Injection site abscess Adacel, Daptacel, Fluarix, Flulaval, PedvaxHIB, Pentacel, Quadracel
Injection site bruising Adacel, Flulaval
Injection site cellulitis Afluria, Daptacel, Fluarix, Flulaval, Pediarix, Quadracel, Tenivac
Injection site reactions (mass, pain, warmth) Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Tdvax, Tenivac, Twinrix
Injection site rash Daptacel, Flulaval, IPOL, Prevnar-13
Listlessness Quadracel
Malaise Gardasil/Gardasil 9, MMR-II, Pneumovax-23, Tdvax, Twinrix
Peripheral edema ActHIB, MMR-II, Pneumovax-23, ProQuad, Tdvax, Tenivac, Varivax
Pyrexia [fever] Tdvax
Swelling MMR-II, ProQuad
Hepatobiliary/liver (3) Elevation of liver enzymes Recombivax
Hepatitis Havrix, Twinrix
Jaundice Havrix, Twinrix
Immune system (5) Allergic reactions/hypersensitivity* ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix
Anaphylactic and anaphylactoid reactions, including shock* ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax
Angioedema,* angioneurotic edema ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, RotaTeq, Tenivac, Twinrix, Varivax
Edema Adacel
Serum sickness* Afluria, Engerix-B, Fluarix, Havrix, Pneumovax-23, Recombivax, Twinrix
Infections and infestations (29) Atypical measles MMR-II, ProQuad
Bronchitis Infanrix, ProQuad
Candidiasis* ProQuad
Cellulitis Daptacel, Infanrix, Pneumovax-23, ProQuad, Tdvax, Varivax
Early-onset Hib disease PedvaxHIB
Herpes simplex ProQuad
Herpes zoster [shingles] Engerix-B, ProQuad, Recombivax, Twinrix, Varivax
Infection ProQuad
Influenza, influenza-like illness Afluria, Flulaval, Havrix, ProQuad
Invasive Hib disease Pentacel
Kawasaki disease* [blood vessel disease] Rotarix, RotaTeq
Laryngitis Flulaval
Measles ProQuad
Measles-like rash MMR-II
Meningitis (aseptic, eosinophilic) Engerix-B, FluMist, MMR-II, Pentacel, ProQuad, Twinrix, Varivax
Pharyngitis Fluarix, Varivax
Pneumonia, pneumonitis MMR-II, ProQuad, Varivax
Pulmonary congestion ProQuad
Respiratory tract infection Infanrix, Pediarix, ProQuad
Rhinitis Fluarix, Flulaval, Havrix, MMR-II, Pentacel, ProQuad
Secondary bacterial infections (skin, tissue) Varivax
Sinusitis ProQuad
Skin infection ProQuad
Sore throat MMR-II, ProQuad
Tonsillitis Fluarix
Transmission of vaccine virus strains RotaTeq
Varicella (vaccine strain) ProQuad, Varivax
Varicella-like rash ProQuad
Viral infection Pentacel
Investigations (2) Abnormal liver function tests Engerix-B, Twinrix
Increased serum C-reactive protein Pneumovax-23
Metabolic (3) Decreased appetite Pentacel
Diabetes mellitus* MMR-II
Mitochondrial encephalomyopathy, Leigh syndrom exacerbation [neurometabolic] FluMist
Musculoskeletal/connective tissue (13) Arthralgia [joint pain] Boostrix, Engerix-B, IPOL, MMR-II, Pneumovax-23, ProQuad, Recombivax, Tdvax, Twinrix
Arthritis Engerix-B, Flulaval, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix
Back pain Boostrix
Hypotonia [low muscle tone] Daptacel, Hiberix, Infanrix, Pediarix, Prevnar-13, Quadracel
Lupus-like syndrome* Recombivax
Muscle spasm Adacel
Muscle weakness Engerix-B, Flulaval, Recombivax, Twinrix
Musculoskeletal pain ProQuad
Musculoskeletal stiffness Havrix
Myalgia [muscle pain] Boostrix, IPOL, MMR-II, ProQuad, Tdvax, Tenivac
Myositis [muscle inflammation] Adacel
Pain in extremities Fluarix, Fluzone, Pediarix, Recombivax, Tdvax, Tenivac
Systemic lupus erythematosus* Recombivax
Nervous system (41) Acute disseminated encephalomyelitis MMR-II, ProQuad
Ataxia [nervous system dysfunction] MMR-II, ProQuad, Varivax
Bulging fontanelle Pediarix
Cerebellar ataxia Vaqta
Convulsions/seizures ActHIB, Adacel, Afluria, Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Havrix, Hiberix, IPOL, Kinrix, MMR-II, Quadracel, Recombivax, Tdvax, Twinrix, Varivax
Depressed level of consciousness Boostrix, Pediarix, Pentacel
Dizziness Fluarix, Flulaval, Fluzone, Havrix, MMR-II, ProQuad, Tdvax, Tenivac, Varivax
Encephalitis, vaccine-induced encephalitis [brain inflammation] Boostrix, Engerix-B, FluMist, MMR-II, Pediarix, Recombivax, Twinrix, Vaqta, Varivax
Encephalomyelitis [brain and spinal cord] Afluria, Fluarix, Fluzone
Encephalopathy [brain disease] Afluria, Engerix-B, Flulaval, Havrix, Infanrix, MMR-II, ProQuad, Twinrix
Facial palsy, Bell’s palsy Adacel, Boostrix, Engerix-B, Fluarix, FluMist, Fluzone, ProQuad, Recombivax, Twinrix, Varivax
Facial (or cranial) nerve paralysis Flulaval
Facial paresis [impaired facial movement] Fluarix
Febrile convulsions/seizures Afluria, Daptacel, Fluzone, IPOL, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Quadracel, Recombivax
Guillain-Barré syndrome* Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax
Headache DT, Infanrix, IPOL, MMR-II, ProQuad, Tdvax, Twinrix
Hypoesthesia [decreased tactile sensitivity] Adacel, Engerix-B, Fluarix, Flulaval, Havrix, Recombivax, Twinrix
Hypokinesia [loss of muscle movement] Flulaval
Hypotonic-hyporesponsive episode to immunization (HHE) Daptacel, Hiberix, Kinrix, Pediarix, Pentacel, Quadracel
Lethargy Pediarix
Limb paralysis Flulaval
Measles inclusion body encephalitis MMR-II, ProQuad
Migraine Engerix-B, Recombivax
Multiple sclerosis (or MS exacerbation)* Engerix-B, Havrix, Recombivax, Twinrix
Myelitis [spinal cord disease] Adacel, Fluarix, Fluzone, Havrix, Recombivax, Twinrix
Neuralgia [nerve pain] Afluria
Neuritis (including brachial, polyneuritis) Adacel, Afluria, Engerix-B, Fluarix, Fluzone, MMR-II, Twinrix
Neuropathy, polyneuropathy Afluria, Engerix-B, Fluarix, Havrix, MMR-II, ProQuad, Recombivax, Twinrix
Ocular palsies* [nerve damage] MMR-II, ProQuad
Optic neuritis/neuropathy, papillitis* [inflammation of optic nerve] Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix
Paralysis Engerix-B, Twinrix
Paresis [partial paralysis] Engerix-B, Twinrix
Paresthesia [abnormal skin sensations] Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, IPOL, MMR-II, Pneumovax-23, ProQuad, Tenivac, Varivax
Partial seizures, seizures Daptacel, Engerix-B, ProQuad
Presyncope [feeling faint] Flucelvax
Radiculopathy [“pinched nerve” in spine] Pneumovax-23, Recombivax
Somnolence Daptacel, DT, Flulaval, Havrix, Hiberix, IPOL, Pediarix, Pentacel, Quadracel, Recombivax
Subacute sclerosing panencephalitis MMR-II, ProQuad
Syncope, vasovagal syncope [fainting] Adacel, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, ProQuad, Recombivax, Tenivac, Trumenba
Transverse myelitis Afluria, Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix, Varivax
Tremors Flulaval, ProQuad
Psychiatric (8) Agitation IPOL, ProQuad, Recombivax
Crying/unusual crying Pediarix
Hypersomnia ProQuad
Insomnia Flulaval, Pediarix
Irritability MMR-II, Recombivax
Nervousness Pediarix, ProQuad
Restlessness Pediarix
Screaming Daptacel, Pediarix, Pentacel, Quadracel
Respiratory, thoracic and mediastinal (12) Apnea Engerix-B, Hiberix, Infanrix, Kinrix, Pediarix, Pentacel, Prevnar-13
Asthma, asthma-like symptoms Engerix-B, Fluarix, Twinrix
Bronchospasm Engerix-B, Fluarix, Flulaval, MMR-II, ProQuad, Recombivax, Tenivac, Twinrix
Cough Fluarix, Fluzone, Infanrix, MMR-II, Pediarix, Pentacel
Cyanosis* [bluish discoloration, low oxygen] Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel
Dyspnea [shortness of breath] Fluarix, Flulaval, Fluzone, Havrix, Pediarix, Quadracel, Twinrix
Dysphonia [vocal abnormalities] Flulaval
Oropharyngeal pain Fluzone
Respiratory distress Fluarix
Rhinorrhea [runny nose] Fluzone
Stridor [high-pitched wheezing] Fluarix
Throat tightness Flulaval, Fluzone
Wheezing Fluzone, ProQuad
Skin/ subcutaneous tissue (22) Acute hemorrhagic edema of infancy MMR-II, ProQuad
Alopecia [hair loss] Engerix-B, Recombivax, Twinrix
Ecchymoses [subcutaneous bleeding] Engerix-B, Recombivax, Twinrix
Eczema Engerix-B, Recombivax, Twinrix
Erythema [skin redness] Fluarix, Infanrix, MMR-II, Pediarix, Pentacel, Tdvax
Erythema multiforme [skin disorder] Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Prevnar-13, Recombivax, Twinrix, Varivax
Erythema nodosum [nodules or lumps] Engerix-B, Recombivax, Twinrix
Exanthem [widespread rash] Boostrix
Facial swelling/edema Daptacel, Fluarix, MMR-II, ProQuad, Varivax
Hyperhydrosis [abnormal sweating] Flulaval, Havrix, Twinrix
Impetigo ProQuad, Varivax
Lichen planus [inflammatory skin rash] Engerix-B, Twinrix
Panniculitis [disease of fatty layer of skin] MMR-II, ProQuad
Parotitis [salivary gland inflammation] MMR-II, ProQuad
Pruritus [itchy skin] ActHIB, Adacel, Afluria, Boostrix, Daptacel, Fluarix, Flucelvax, Flulaval, Fluzone, Infanrix, Kinrix, MMR-II, Prevnar-13, ProQuad, Tdvax, Tenivac
Purpura [red/purple spots] Engerix-B, MMR-II, ProQuad
Rash ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Tdvax, Tenivac
Skin discoloration Pentacel
Skin induration MMR-II, ProQuad
Stevens-Johnson syndrome [severe skin reaction] Engerix-B, Fluarix, Fluzone, MMR-II, ProQuad, Recombivax, Varivax
Urticaria* [hives] ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix
Vesiculation MMR-II
Vascular (8) Cerebrovascular accident ProQuad, Varivax
Flushing Flulaval, Fluzone
Henoch-Schönlein purpura [blood vessel inflammation] Boostrix, Fluarix, MMR-II, ProQuad, Varivax
Pallor DT, Flulaval, Hiberix, Pediarix, Pentacel, Prevnar-13, Quadracel
Petechiae [bleeding capillaries] Pediarix, Recombivax
Polyarteritis nodosa [damaged arteries] Recombivax
Renal vasculitis Afluria
Vasculitis Afluria, Engerix-B, Fluarix, Fluzone, Havrix, MMR-II, Recombivax, Twinrix
Urogenital (2) Epididymitis [testicular inflammation] MMR-II, ProQuad
Orchitis [inflammation of the testes] MMR-II, ProQuad

*There are several things to note about the information presented in Table 2. First, while we used the verbatim insert terminology for each disorder and also largely stuck to the disease groupings in the package inserts, we added two categories—allergic and autoimmune disorders—that the inserts surprisingly omit. (The package inserts lump allergic reactions in with “immune system disorders.”) Second, there are a number of disorders that fit in more than one category; in those instances, we have included them (with an asterisk*) in both places (while counting them once). Third, the table only includes those adverse events that manufacturers decided to report in the inserts—but other adverse events are not only possible but likely, due to the widespread problem of underreporting. Notably, none of the package inserts include any mention of prevalent, childhood-onset neurodevelopmental disorders like tics or autism that published, peer-reviewed studies have linked to vaccines.

 

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