thelibertybeacon--2020-08-18--Read the Fine Print: Vaccine Package Inserts Reveal Hundreds of Medical Conditions Linked to Vaccine

Read the Fine Print : Vaccine Package Inserts Reveal Hundreds of Medical Conditions Linked to Vaccines 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 @ @ @ @ @ @ @ 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 ?
Vaccines belong to the class of pharmaceutical products called biologics , @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ linked to vaccines .
As readers peruse Table 2 , they may notice the following themes : • None 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 @ @ @ @ @ @ @ unknown.
” • None 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 .
• None Vaccine adverse events affect numerous body systems , including the immune and nervous systems .
Although the @ @ @ @ @ @ @ 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 .
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 .
@ @ @ @ @ @ @ ) , 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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.
” [ Note : Medical conditions with asterisks appear in more than one category . ]
*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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ childhood-onset neurodevelopmental disorders like tics or autism that published , peer-reviewed studies have linked to vaccines .
The Liberty Beacon Project is now expanding at a near exponential rate , and for this we are grateful and excited !
But we must also be practical .
For 7 years we have not asked for any donations , and have built this project with our own funds as we grew .
We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent .
So we have @ @ @ @ @ @ @ and ask that you consider this when you visit them .
Nothing is too small .
We thank you for all your support and your considerations … ( TLB )

Read the Fine Print: Vaccine Package Inserts Reveal Hundreds of Medical Conditions Linked to Vaccines
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. 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. 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.”
Table 1. Vaccine package inserts reviewed
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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thelibertybeacon--2020-08-19--Read the Fine Print (Part 2) – Nearly 400 Adverse Reactions Listed in Vaccine Package Inserts

See link to Part 1 below article Package inserts are available online for all vaccines licensed in the U.S .
In addition to containing bits of practical information for the clinicians who administer the vaccines , the inserts provide members of the public with one of their only opportunities to learn about a vaccine ’ s contraindications , warnings , precautions and—perhaps most importantly—potential adverse reactions .
The inserts communicate the information about adverse reactions in two distinct sections : “ Clinical trials experience ” ( Section 6.1 ) and “ Data from postmarketing experience ” from the U.S. or @ @ @ @ @ @ @ In April , 2020 , Children ’ s Health Defense summarized the postmarketing data for over three dozen vaccines given routinely to American infants , children and adolescents .
That tally showed that vaccines touted for the prevention of 13 illnesses ( Table 1 ) have been linked to at least 217 adverse medical outcomes reported post-licensure , including serious infections , autoimmune conditions , life-threatening allergies and death .
As noted in April , the postmarketing list is far from exhaustive , because manufacturers have the latitude to decide which outcomes to @ @ @ @ @ @ @ by severity , frequency of reporting and “ strength of evidence for a causal relationship.
” In addition , vaccine adverse events are notoriously underreported , not least because medical schools do not teach doctors to recognize vaccine injuries .
But what would the picture look like if the adverse reactions observed during clinical trials were also added to the list ?
This combination of clinical trial and postmarketing data presents a dramatic picture , with almost double the total number of undesirable post-vaccination outcomes … Children ’ s Health Defense can now @ @ @ @ @ @ @ ( Table 2 ) includes the adverse reactions reported in the clinical trial sections of 41 vaccine brands covering diphtheria , Haemophilus influenzae type b , hepatitis A , hepatitis B , human papillomavirus , influenza , meningococcal infection , pertussis , pneumococcal infection , polio , rotavirus , tetanus and varicella .
This combination of clinical trial and postmarketing data presents a dramatic picture , with almost double the total number of undesirable post-vaccination outcomes—397 different types of reactions reported pre- and post-licensure .
Although roughly 400 adverse events is a sobering @ @ @ @ @ @ @ an underestimate .
This is because most clinical trials follow participants for an absurdly short period of time—three days here , seven days there—and do not capture problems that arise beyond that brief window , even though clinicians recognize ( and the scientific literature confirms ) that vaccine reactions are not always immediate or acute .
Moreover , even for those few days of monitoring , the inserts are often short on details , citing only a smattering of adverse events collected from a predetermined list of “ solicited ” reactions and only @ @ @ @ @ @ @ In addition , the fact that vaccine clinical trials typically compare vaccine against vaccine rather than vaccine against inert placebo makes it easy to divert attention from specific adverse reactions by simply citing “ similar rates ” of adverse reactions in both groups .
… and that vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent .
The April discussion of postmarketing adverse events noted several themes , including the facts that all vaccines are capable of producing adverse reactions ( though Gardasil and Gardasil 9 @ @ @ @ @ @ @ can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent .
The clinical trial data reinforce these points and also highlight some new themes : • None The adverse reactions reported following clinical trials do not necessarily match up to the adverse reactions reported post-licensure .
This is particularly the case for vaccine-associated deaths ; whereas the April postmarketing-only list included just two categories of death associated with six vaccines , the addition of clinical trial data brings the total up to 40 types of death associated with @ @ @ @ @ @ @ of participants in vaccine clinical trials experience unpleasant reactions , including fever , chills , pain , nausea , diarrhea , vomiting , headache , rash , loss of appetite and irritability .
For example , in clinical trials for the five-pronged Pentacel vaccine ( diphtheria , tetanus , pertussis , Haemophilus influenzae type b and polio ) —given as a four-dose series beginning at six weeks of age—almost half of the young children ( 48 % ) experienced injection-site “ tenderness ” after the first dose ( defined as “ whimpering ” @ @ @ @ @ @ @ was touched or moved ) ; about the same percentage ( 46 % ) experienced “ lethargy , ” 59 % cried “ inconsolably ” and 77 % were “ fussy ” or “ irritable.
” In adolescents , the Adacel vaccine given as a booster for tetanus-diphtheria-acellular pertussis ( Tdap ) produced injection-site pain in almost eight in ten teens ( 78 % ) , and one in five ( 20 % ) study participants experienced pain rated as “ moderate to severe.
” More than two-fifths ( 44 % ) suffered @ @ @ @ @ @ @ also document more serious reactions with the potential to cause longer-term problems .
Adverse reactions of particular concern—especially in the young—include asthma , seizures , heart problems , sleep problems and joint and muscle pain .
Nine vaccines list anorexia as a clinical trial reaction .
Surprisingly , while numerous package inserts mention serious and potentially lifelong conditions like transverse myelitis ( 11 vaccines ) and Guillain-Barré syndrome ( 20 vaccines ) in their postmarketing section , only a few list them as a clinical trial outcome despite hundreds of published studies pointing @ @ @ @ @ @ @ and unintentional injuries are more prominent in the clinical trial data than in the postmarketing reports , particularly in association with Gardasil and certain meningococcal vaccines ( abbreviated as MenACWY ) .
These events include alcohol intoxication and drug overdose ; suicidal thoughts or attempts ; head and limb injuries ; and falls resulting in injuries .
Noting that syncope ( fainting ) is a common post-vaccination reaction in adolescents and young adults , the CDC states , “ In 2005 , the Vaccine Adverse Event Reporting System ( VAERS ) began detecting @ @ @ @ @ @ @ coincided with the licensure of 3 vaccines for adolescents : human papillomavirus ( HPV ) , MenACWY , and Tdap .
Of particular concern among adolescents has been the risk for serious secondary injuries , including skull fracture and cerebral hemorrhage.
” ( One of the robustly healthy volunteers in the current clinical trials for the Moderna Covid-19 vaccine illustrated this very point , narrowly escaping injury when his girlfriend caught him in the midst of a fainting episode . )
• None Illustrating how vaccines can cause what they are supposed to @ @ @ @ @ @ @ ProQuad measles-mumps-rubella-varicella vaccine—intended to prevent infections associated with rashes—highlighted an astounding array of rashes .
The ProQuad insert lists seven different types of rash-related adverse reactions : “ rash , ” “ injection-site rash , ” “ measles-like rash , ” “ rubella-like rash , ” “ varicella-like rash , ” “ vesicular rash ” and “ viral exanthema ” ( an eruptive rash associated with viral infections ) .
Across both the clinical trial and postmarketing data , ProQuad injection also appears to precede numerous infections , including “ atypical measles ” @ @ @ @ @ @ @ , bronchitis , cellulitis and other skin infections , herpes simplex ( cold sores ) , herpes zoster ( shingles ) , influenza or “ influenza-like illness , ” meningitis , pneumonia , respiratory tract infections , sinusitis , sore throats and other viral infections .
Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts .
One of the autoimmune conditions encountered during the clinical trials for meningococcal and rotavirus vaccines ( and also reported post-licensure ) is a condition @ @ @ @ @ @ @ Diagnosed solely on the basis of symptoms ( high fever plus symptoms such as rash , redness and lymph node swelling ) , KD came out of nowhere in the 1960s and 1970s when childhood vaccine programs were starting to gear up .
The published literature confirms Bexero meningococcal B and rotavirus vaccination as likely triggers for KD and , in addition , points to numerous other vaccines as possible culprits , including those for hepatitis A , hepatitis B , influenza , Prevnar-13 and multiple vaccines administered in a single health care @ @ @ @ @ @ @ as a “ condition of interest ” for pediatric vaccine safety surveillance .
Ordinarily fairly obscure , KD made headlines this year when researchers started speculating that it might be one of the apparently myriad faces of SARS-CoV-2 .
In the UK—the first country in the world to start administering ( in 2015 ) three doses of Bexero to infants—researchers were also the first to suggest that KD might be Covid-19-related .
This week , a different group of researchers raised the same question about another low-profile autoimmune condition , myasthenia gravis , @ @ @ @ @ @ @ be connected to SARS-CoV-2 .
Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts .
This information clearly points the way to a different set of questions and answers , pertaining not only to autoimmunity but also to the many other health problems besieging American children .
Table 2 .
Clinical trial and post-marketing adverse events reported in vaccine package inserts , by body system The Liberty Beacon Project is now expanding at a near exponential rate , and for @ @ @ @ @ @ @ But we must also be practical .
For 7 years we have not asked for any donations , and have built this project with our own funds as we grew .
We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent .
So we have just installed donation buttons on our websites and ask that you consider this when you visit them .
Nothing is too small .
We thank you for all your support and your considerations … ( TLB )

Read the Fine Print, Part Two—Nearly 400 Adverse Reactions Listed in Vaccine Package Inserts
See link to Part 1 below article
By: the Children’s Health Defense Team
Package inserts are available online for all vaccines licensed in the U.S. In addition to containing bits of practical information for the clinicians who administer the vaccines, the inserts provide members of the public with one of their only opportunities to learn about a vaccine’s contraindications, warnings, precautions and—perhaps most importantly—potential adverse reactions.
The inserts communicate the information about adverse reactions in two distinct sections: “Clinical trials experience” (Section 6.1) and “Data from postmarketing experience” from the U.S. or other countries (Section 6.2). In April, 2020, Children’s Health Defense summarized the postmarketing data for over three dozen vaccines given routinely to American infants, children and adolescents. That tally showed that vaccines touted for the prevention of 13 illnesses (Table 1) have been linked to at least 217 adverse medical outcomes reported post-licensure, including serious infections, autoimmune conditions, life-threatening allergies and death.
As noted in April, the postmarketing list is far from exhaustive, because manufacturers have the latitude to decide which outcomes to list in the inserts—using loose criteria determined by severity, frequency of reporting and “strength of evidence for a causal relationship.” In addition, vaccine adverse events are notoriously underreported, not least because medical schools do not teach doctors to recognize vaccine injuries. But what would the picture look like if the adverse reactions observed during clinical trials were also added to the list?
This combination of clinical trial and postmarketing data presents a dramatic picture, with almost double the total number of undesirable post-vaccination outcomes …
Double trouble
Children’s Health Defense can now answer that question. The revised chart (Table 2) includes the adverse reactions reported in the clinical trial sections of 41 vaccine brands covering diphtheria, Haemophilus influenzae type b, hepatitis A, hepatitis B, human papillomavirus, influenza, meningococcal infection, pertussis, pneumococcal infection, polio, rotavirus, tetanus and varicella. This combination of clinical trial and postmarketing data presents a dramatic picture, with almost double the total number of undesirable post-vaccination outcomes—397 different types of reactions reported pre- and post-licensure.
Although roughly 400 adverse events is a sobering number, again, it is probably an underestimate. This is because most clinical trials follow participants for an absurdly short period of time—three days here, seven days there—and do not capture problems that arise beyond that brief window, even though clinicians recognize (and the scientific literature confirms) that vaccine reactions are not always immediate or acute. Moreover, even for those few days of monitoring, the inserts are often short on details, citing only a smattering of adverse events collected from a predetermined list of “solicited” reactions and only sometimes accepting “unsolicited” feedback. In addition, the fact that vaccine clinical trials typically compare vaccine against vaccine rather than vaccine against inert placebo makes it easy to divert attention from specific adverse reactions by simply citing “similar rates” of adverse reactions in both groups.
… and that vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent.
Clinical trial themes
The April discussion of postmarketing adverse events noted several themes, including the facts that all vaccines are capable of producing adverse reactions (though Gardasil and Gardasil 9 are macabre standouts) and that vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent. The clinical trial data reinforce these points and also highlight some new themes:
The adverse reactions reported following clinical trials do not necessarily match up to the adverse reactions reported post-licensure. This is particularly the case for vaccine-associated deaths; whereas the April postmarketing-only list included just two categories of death associated with six vaccines, the addition of clinical trial data brings the total up to 40 types of death associated with 13 vaccines.
Sizeable proportions of participants in vaccine clinical trials experience unpleasant reactions, including fever, chills, pain, nausea, diarrhea, vomiting, headache, rash, loss of appetite and irritability. For example, in clinical trials for the five-pronged Pentacel vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b and polio)—given as a four-dose series beginning at six weeks of age—almost half of the young children (48%) experienced injection-site “tenderness” after the first dose (defined as “whimpering” or crying when the arm or leg was touched or moved); about the same percentage (46%) experienced “lethargy,” 59% cried “inconsolably” and 77% were “fussy” or “irritable.” In adolescents, the Adacel vaccine given as a booster for tetanus-diphtheria-acellular pertussis (Tdap) produced injection-site pain in almost eight in ten teens (78%), and one in five (20%) study participants experienced pain rated as “moderate to severe.” More than two-fifths (44%) suffered from headaches.
Clinical trials also document more serious reactions with the potential to cause longer-term problems. Adverse reactions of particular concern—especially in the young—include asthma, seizures, heart problems, sleep problems and joint and muscle pain. Nine vaccines list anorexia as a clinical trial reaction. Surprisingly, while numerous package inserts mention serious and potentially lifelong conditions like transverse myelitis (11 vaccines) and Guillain-Barré syndrome (20 vaccines) in their postmarketing section, only a few list them as a clinical trial outcome despite hundreds of published studies pointing to post-vaccination onset.
Intentional and unintentional injuries are more prominent in the clinical trial data than in the postmarketing reports, particularly in association with Gardasil and certain meningococcal vaccines (abbreviated as MenACWY). These events include alcohol intoxication and drug overdose; suicidal thoughts or attempts; head and limb injuries; and falls resulting in injuries. Noting that syncope (fainting) is a common post-vaccination reaction in adolescents and young adults, the CDC states, “In 2005, the Vaccine Adverse Event Reporting System (VAERS) began detecting a trend of increasing syncope reports that coincided with the licensure of 3 vaccines for adolescents: human papillomavirus (HPV), MenACWY, and Tdap. Of particular concern among adolescents has been the risk for serious secondary injuries, including skull fracture and cerebral hemorrhage.” (One of the robustly healthy volunteers in the current clinical trials for the Moderna Covid-19 vaccine illustrated this very point, narrowly escaping injury when his girlfriend caught him in the midst of a fainting episode.)
Illustrating how vaccines can cause what they are supposed to prevent, the clinical trials for the ProQuad measles-mumps-rubella-varicella vaccine—intended to prevent infections associated with rashes—highlighted an astounding array of rashes. The ProQuad insert lists seven different types of rash-related adverse reactions: “rash,” “injection-site rash,” “measles-like rash,” “rubella-like rash,” “varicella-like rash,” “vesicular rash” and “viral exanthema” (an eruptive rash associated with viral infections). Across both the clinical trial and postmarketing data, ProQuad injection also appears to precede numerous infections, including “atypical measles” and measles, varicella (chickenpox), bronchitis, cellulitis and other skin infections, herpes simplex (cold sores), herpes zoster (shingles), influenza or “influenza-like illness,” meningitis, pneumonia, respiratory tract infections, sinusitis, sore throats and other viral infections.
Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts.
Mysteries explained?
One of the autoimmune conditions encountered during the clinical trials for meningococcal and rotavirus vaccines (and also reported post-licensure) is a condition called Kawasaki disease (KD). Diagnosed solely on the basis of symptoms (high fever plus symptoms such as rash, redness and lymph node swelling), KD came out of nowhere in the 1960s and 1970s when childhood vaccine programs were starting to gear up. The published literature confirms Bexero meningococcal B and rotavirus vaccination as likely triggers for KD and, in addition, points to numerous other vaccines as possible culprits, including those for hepatitis A, hepatitis B, influenza, Prevnar-13 and multiple vaccines administered in a single health care visit. Canadian researchers have identified KD as a “condition of interest” for pediatric vaccine safety surveillance.
Ordinarily fairly obscure, KD made headlines this year when researchers started speculating that it might be one of the apparently myriad faces of SARS-CoV-2. In the UK—the first country in the world to start administering (in 2015) three doses of Bexero to infants—researchers were also the first to suggest that KD might be Covid-19-related. This week, a different group of researchers raised the same question about another low-profile autoimmune condition, myasthenia gravis, asking whether it, too, could be connected to SARS-CoV-2. Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts. This information clearly points the way to a different set of questions and answers, pertaining not only to autoimmunity but also to the many other health problems besieging American children.
Table 1. Vaccine package inserts reviewed
Table 2. Clinical trial and post-marketing adverse events reported in vaccine package inserts, by body system
Body System Medical Disorder Reported in Clinical
Trials Reported Post-marketing Allergic (6) Allergic reactions/
hypersensitivity Varivax ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Gardasil/Gardasil 9, Hiberix, Infanrix, IPOL, Kinrix, Menveo, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix Allergy to vaccine Gardasil/Gardasil 9 Anaphylaxis and
anaphylactoid reactions, including shock Bexero, Fluarix, MMR-II ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menveo, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax Angioedema,
angioneurotic edema Menveo, MMR-II, Recombivax ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Menomune, 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] Engerix-B, Havrix,
MMR-II, PedVaxHIB, Prevnar-13, Recombivax, Twinrix, Vaqta, Varivax ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Hiberix, Infanrix, IPOL, Kinrix, Menactra, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix Autoimmune (15) Autoimmune diseases Gardasil/Gardasil 9 Autoimmune thyroiditis Gardasil/Gardasil 9 Celiac disease Gardasil/Gardasil 9 Cutaneous lupus
erythematosus Gardasil/Gardasil 9 Diabetes mellitus
(insulin-dependent) Boostrix,
Gardasil/Gardasil 9, Pediarix, Pneumovax-23 MMR-II Graves’/Basedow’s
disease Gardasil/Gardasil 9 Guillain-Barré syndrome
(GBS) IPOL, MMR-II, PedVaxHIB Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax Kawasaki disease Menveo, Rotarix,
RotaTeq Rotarix, RotaTeq Lupus-like syndrome Recombivax Multiple sclerosis (or
exacerbation) Gardasil/Gardasil 9 Engerix-B, Havrix,
Recombivax, Twinrix Pancreatitis MMR-II, Pneumovax-23 Gardasil/Gardasil 9, MMR-II Rheumatoid arthritis/juvenile
rheumatoid arthritis Gardasil/Gardasil 9 Scleroderma Gardasil/Gardasil 9 Systemic lupus
erythematosus Gardasil/Gardasil 9 Recombivax Thrombocytopenia/idiopathic
thrombocytopenic purpura (ITP) [low platelets] Daptacel, Gardasil/Gardasil 9, MMR-II, PedVaxHIB Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Rotarix, Twinrix, Vaqta, Varivax Blood/lymphatic system
(11) Anemia (aplasic or
hemolytic) Gardasil/Gardasil 9,
Pneumovax-23, ProQuad, Varivax Epistaxis [nosebleed] FluMist, ProQuad Extravasation [blood
vessel leakage] ProQuad Hematochezia [bloody
stools] RotaTeq ProQuad, Rotarix,
RotaTeq Hemorrhage Gardasil/Gardasil 9 Increased erythrocyte
sedimentation rate Recombivax Leukocytosis [increased
white blood cells] MMR-II MMR-II, Pneumovax-23 Lymphadenitis/swollen
lymph nodes Adacel Boostrix, Pneumovax-23,
ProQuad Lymphadenopathy,
including regional Engerix-B, Havrix, MMR-II, Recombivax, Varivax Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, IPOL, Kinrix, Menactra, Menveo, MMR-II, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Tenivac Neutropenia, chronic Pediarix Thrombocytopenia/idiopathic
thrombocytopenic purpura (ITP) [low platelets]* Daptacel,
Gardasil/Gardasil 9, MMR-II, PedVaxHIB Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Rotarix, Twinrix, Vaqta, Varivax Cardiac (10) Angina pectoris Pneumovax-23, Tenivac Cyanosis* [bluish,
low oxygen] Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel Heart failure Pneumovax-23 Hypotension Engerix-B, Recombivax Adacel, Menactra Myocardial infarction Pneumovax-23 Myocarditis [heart
muscle inflammation] Gardasil/Gardasil 9 Adacel, Boostrix Palpitations Engerix-B, Twinrix Pericarditis [pericardial
inflammation] FluMist Pleuropericarditis Flublok (> age 50) Tachycardia [abnormally
high heart rate] Engerix-B, Fluarix,
Recombivax, Twinrix Congenital (1) Congenital anomaly Havrix Death, by cause (40) Unspecified Flublok, IPOL,
Prevnar-13, Tenivac Gardasil/Gardasil 9 Acute lymphocytic
leukemia Gardasil/Gardasil 9 Acute renal failure Gardasil/Gardasil 9 Arrhythmia Gardasil/Gardasil 9 Asphyxia Pentacel Aspiration Daptacel Autoimmune disease Gardasil/Gardasil 9 Breast cancer Gardasil/Gardasil 9 Cardiopulmonary arrest Tenivac Cardiovascular Prevnar-13,
Pneumovax-23 Cerebral hemorrhage Gardasil/Gardasil 9 Cerebrovascular
accident Gardasil/Gardasil 9 Congenital
immunodeficiency and sepsis Pediarix Convulsive disorder Pediarix Drug overdose Gardasil/Gardasil 9 Fetal MMR-II Gunshot wound Gardasil/Gardasil 9 Head trauma Pentacel Homicide Gardasil/Gardasil 9 Hyperthyroidism Gardasil/Gardasil 9 Hypovolemic septic
shock Gardasil/Gardasil 9 Infectious disease Gardasil/Gardasil 9 Intussusception RotaTeq Rotarix, RotaTeq Motor vehicle accident Gardasil/Gardasil 9 Myocardial infarction Tenivac Nasopharyngeal cancer Gardasil/Gardasil 9 Neoplasm Gardasil/Gardasil 9,
Prevnar-13 Neuroblastoma Pediarix, Pentacel Pancreatic cancer Gardasil/Gardasil 9 Peritonitis Prevnar-13 Pneumonia Rotarix Pulmonary embolism Gardasil/Gardasil 9 Pulmonary infection Prevnar-13 Pulmonary tuberculosis Gardasil/Gardasil 9 Sepsis, septic shock Gardasil/Gardasil 9,
Menveo, Prevnar-13 Stomach adenocarcinoma Gardasil/Gardasil 9 Sudden infant death
syndrome (SIDS) Menveo, Pediarix,
Pentacel, Prevnar-13, RotaTeq Infanrix Suicide Gardasil/Gardasil 9 Traumatic brain
injury/cardiac arrest Gardasil/Gardasil 9 Unexplained sudden
death Gardasil/Gardasil 9 Ear/labyrinth (8) Earache Recombivax Ear pain Engerix-B, Infanrix,
Menveo, ProQuad, Twinrix Hearing impaired Menveo Nerve deafness MMR-II MMR-II, ProQuad Otitis media/ear
infection Afluria, Fluarix,
PedVaxHIB, RotaTeq, Vaqta, Varivax MMR-II Tinnitis Engerix-B, Recombivax,
Twinrix Vertigo Havrix, Recombivax,
Twinrix Engerix-B, Fluarix,
Menveo Vestibular/balance
disorder Menveo Endocrine (6) Cushing’s syndrome Menveo Goiter Gardasil/Gardasil 9 Hyperthyroidism Gardasil/Gardasil 9 Hypothyroidism Gardasil/Gardasil 9 Thyroiditis Gardasil/Gardasil 9 Toxic nodular goiter Gardasil/Gardasil 9 Eye (17) Conjunctivitis Vaqta Eye complaints Varivax Eye irritation/itching Vaqta Eye pain Fluarix, Flulaval Eye redness Fluarix Eye swelling Bexero, Fluarix Eyelid ptosis [drooping] Menveo Eyelid swelling Fluarix, ProQuad Keratitis [corneal
inflammation] Engerix-B Ocular hyperemia [eye
inflammation] Fluzone Ocular palsies [nerve
damage] MMR-II MMR-II, ProQuad Optic
neuritis/neuropathy, papillitis [optic nerve inflammation] Gardasil/Gardasil 9,
MMR-II Engerix-B, Fluzone,
MMR-II, ProQuad, Recombivax, Twinrix Photophobia [light
intolerance] Havrix Flulaval Retinitis, necrotizing
[inflammation] MMR-II MMR-II, ProQuad,
Varivax Retrobulbar neuritis [nerve
damage] MMR-II, ProQuad Uveitis [eye
inflammation] Gardasil/Gardasil 9 Recombivax Visual disturbances Engerix-B, Recombivax,
Twinrix Gastrointestinal (21) Abdominal pain,
discomfort Boostrix, Engerix-B, Fluarix, Flulaval, FluMist, Gardasil/Gardasil 9, Havrix, Menomune, Recombivax, Twinrix, Vaqta, Varivax Fluarix, ProQuad Candidiasis ProQuad Colonic polyp Tenivac Constipation Engerix-B, Infanrix,
Vaqta, Varivax Recombivax Crohn’s disease Gardasil/Gardasil 9 Diarrhea Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flulaval, Gardasil/Gardasil 9, Havrix, Hiberix, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq, Trumenba, Twinrix, Vaqta, Varivax Daptacel, FluMist, Menomune,
MMR-II, Pediarix, Pentacel Dysgeusia [altered
sense of taste] Havrix Dyspepsia [indigestion] Pneumovax-23,
Recombivax Engerix-B, Twinrix Dysphagia [swallowing
difficulties] Flulaval Gastroenteritis Flulaval, Gardasil/Gardasil 9, Kinrix, Menveo, Pediarix, Pentacel, Prevnar-13, Rotarix, RotaTeq, Vaqta Rotarix, RotaTeq Gastrointestinal
infection FluMist Inflammatory bowel
disease Gardasil/Gardasil 9 Inguinal hernia Menactra Intussusception,
including recurrent Rotarix, RotaTeq Rotarix, RotaTeq Mouth ulcers ProQuad Nausea Adacel, Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flulaval, Gardasil/Gardasil 9, Havrix, Menveo, MMR-II, Recombivax, Twinrix, Vaqta, Varivax Daptacel, DT, Fluarix, FluMist, Gardasil/Gardasil 9, Menomune, MMR-II, Pneumovax-23, Tdvax Swelling of mouth,
throat or tongue Fluarix Teething Afluria, Vaqta, Varivax Ulcerative colitis Gardasil/Gardasil 9,
Pneumovax-23 Vitello-intestinal duct
remnant Menveo Vomiting ActHIB, Adacel, Afluria, Boostrix, Daptacel, Engerix-B, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, IPOL, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq,
Trumenba, Twinrix, Vaqta, Varivax Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Menomune, MMR-II, Pediarix, Pentacel, Pneumovax-23,
Tenivac General and injection
site (35) Abnormal gait Flulaval Apathy ProQuad Asthenia [fatigue,
weakness] Hiberix, Pneumovax-23,
Vaqta Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, Menomune, Pediarix, Tenivac Body aches Adacel, Recombivax Fluarix Chest pain Pneumovax-23, Tenivac Fluarix, Flulaval, Fluzone Chills/shivering Adacel, Afluria, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Menactra, , Menveo, Prevnar-13, Recombivax, Trumenba, Vaqta, Varivax Fluarix, Gardasil/Gardasil 9, Havrix, Menomune, Twinrix Decreased limb mobility Pneumovax-23 Dehydration Kinrix, Menveo,
Pentacel, Rotarix, Vaqta Drowsiness/sleepiness ActHIB, Daptacel, Fluarix, Flulaval, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, Pediarix, PedvaxHIB Ecchymosis [bruising] Engerix-B, Fluarix, Flucelvax, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta Engerix-B, Recombivax,
Twinrix Edema Vaqta Adacel Fatigue Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Havrix, Menactra, Menomune, Menveo, MMR-II, Prevnar-13, Recombivax, Trumenba, Twinrix, Varivax Gardasil/Gardasil 9, Menomune, Menveo Feeling hot Fluarix Fever/pyrexia ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, MMR-II, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, ProQuad, Quadracel, Recombivax, Rotarix, RotaTeq, Tenivac, Trumenba, Twinrix, Vaqta, Varivax Menomune, Menveo, MMR-II, Pneumovax-23, Tdvax Hematoma Gardasil/Gardasil 9, Havrix, Varivax Hypernatremia [excess
sodium] Kinrix Increased arm
circumference Adacel, Boostrix, Daptacel, Infanrix, Kinrix, Pentacel, Quadracel Increased thigh
circumference Infanrix Injected limb—extensive
swelling Boostrix, Daptacel, Infanrix, Quadracel ActHIB, Bexero, Hiberix, Menactra, Menveo Injection-site abscess Adacel, Daptacel, Fluarix, Flulaval, PedvaxHIB, Pentacel, Quadracel Injection-site bruising Afluria, Gardasil/Gardasil 9, ProQuad, Vaqta Adacel, Flulaval Injection-site
cellulitis Afluria, Daptacel, Fluarix, Flulaval, Menveo, Pediarix, Quadracel, Tenivac Injection-site pain and
other reactions (induration, warmth) ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, Pediarix, PedvaxHIB, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Tdvax, Tenivac, Twinrix Injection-site rash ProQuad, Vaqta, Varivax Daptacel, Flulaval,
IPOL, Prevnar-13 Interference with normal
activity of arm Daptacel, DT,
Prevnar-13 Itching Afluria, Varivax Lightheadedness Recombivax Listlessness Quadracel Malaise Adacel, Afluria, Engerix-B, Fluarix, Flucelvax, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, MMR-II, Quadracel, Recombivax, Tenivac, Varivax Gardasil/Gardasil 9, Menomune, Menveo, MMR-II, Pneumovax-23, Tdvax, Twinrix Medical attention
sought Pediarix Pain in extremity Fluarix Peripheral edema ActHIB, MMR-II, Pneumovax-23, ProQuad, Tdvax, Tenivac, Varivax Severe pain Bexero Swelling Afluria, Adacel, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Fluzone, Infanrix, IPOL, Kinrix, Menactra, Menomune, Pediarix, PedVaxHIB, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax Menveo, MMR-II, ProQuad Tiredness Adacel, FluMist, IPOL Hepatobiliary/liver (3) Elevation of liver
enzymes Recombivax Hepatitis Menveo Havrix, Twinrix Jaundice Havrix, Twinrix Infections and
infestations (51) Appendicitis Gardasil/Gardasil 9,
Menveo Atypical measles MMR-II MMR-II, ProQuad Bronchiolitis Daptacel, Pediarix,
Pentacel, Prevnar-13, RotaTeq Bronchitis Flulaval Infanrix, ProQuad Cellulitis Daptacel, Infanrix,
Tenivac, Vaqta Daptacel, Gardasil/Gardasil 9, Infanrix, Pneumovax-23, ProQuad, Tdvax, Varivax Cellulitis-like
reaction Afluria Chlamydia Gardasil/Gardasil 9 Cholecystitis Tenivac Croup Afluria, Fluzone, Vaqta Early-onset Hib disease PedVaxHIB PedvaxHIB Glomerulonephritis Gardasil/Gardasil 9 Herpes simplex/cold
sore Varivax ProQuad Herpes zoster [shingles] ProQuad, Menactra Engerix-B, ProQuad, Recombivax, Twinrix, Varivax Infection ProQuad Influenza,
influenza-like illness Engerix-B, Fluarix, Gardasil/Gardasil 9, Recombivax, Twinrix Afluria, Flulaval,Havrix, ProQuad Invasive Hib disease Pentacel Laryngitis Menveo Flulaval Laryngotracheo-bronchitis Vaqta Localized infection Tenivac Measles ProQuad Measles-like rash MMR-II, ProQuad, Vaqta MMR-II Meningitis (aseptic,
eosinophilic) Daptacel Engerix-B, FluMist, MMR-II, Pentacel, ProQuad, Twinrix, Varivax Nasal congestion Afluria, Fluarix,
Gardasil/Gardasil 9, Vaqta Pelvic inflammatory
disease Gardasil/Gardasil 9,
Menveo Pharyngitis/
nasopharyngitis Afluria, Bexero, Fluarix, Flulaval, Gardasil/Gardasil 9, Havrix, Pneumovax-23, ProQuad, Recombivax,
RotaTeq, Vaqta Fluarix, Varivax Pharyngitis
streptococcal Vaqta Pharyngolaryngeal pain Fluarix Pneumonia, pneumonitis,
lobar pneumonia, bilateral pneumonia Daptacel, Gardasil/Gardasil 9, Hiberix, Menomune, Menveo, MMR-II, Pentacel, Prevnar-13, RotaTeq, Varivax MMR-II, ProQuad,
Varivax Pulmonary congestion ProQuad Pulmonary embolism Gardasil/Gardasil 9 Gardasil/Gardasil 9 Nephritis/pyelonephritis
[kidney infection] Gardasil/Gardasil 9 Pertussis Daptacel Respiratory congestion Fluarix, Vaqta Respiratory tract
infection (upper or lower) Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Gardasil/Gardasil 9, Havrix, PedVaxHIB, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax Infanrix, Pediarix, ProQuad Rhinitis Fluarix, Flucelvax,
MMR-II, Recombivax, Vaqta Fluarix, Flulaval,
Havrix, MMR-II, Pentacel, ProQuad Roseola Vaqta Rubella-like rash ProQuad, Vaqta Secondary bacterial
infection (skin, tissue) Varivax Sepsis Daptacel, Pediarix Sinusitis FluMist ProQuad Skin infection ProQuad Sore throat FluMist, MMR-II MMR-II, ProQuad Sneezing FluMist Staph infection Menveo Tonsillitis Fluarix Tracheitis PedVaxHIB Transmission of vaccine
virus strains RotaTeq Varicella Flulaval, Menveo Varicella (vaccine
strain) ProQuad, Varivax Varicella-like rash ProQuad, Vaqta, Varivax ProQuad Viral infection ProQuad, Vaqta Pentacel Injury (intentional
and unintentional) (10) Accidental drug ingestion Hiberix Alcohol intoxication Pneumovax-23 Fall Menactra Menveo Falling with injury Gardasil/Gardasil 9 Head injury Menveo Intentional
multiple-drug overdose Menveo Limb injury Menveo Road accident Menveo Suicidal depression Menveo Suicide attempt Menveo Investigations (6) Abnormal liver function
tests Engerix-B, Twinrix Alanine
aminotransferase increased Menveo Body temperature
increased Menveo Creatine phosphokinase
increased Havrix Diagnostic studies Pediarix Increased serum
C-reactive protein Pneumovax-23 Metabolic (3) Change in eating habits Menveo Loss of appetite,
decreased appetite Afluria, DT, Fluarix, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Pediarix, Prevnar-13, Recombivax, Rotarix, Varivax Pentacel Mitochondrial
encephalomyopathy, Leigh syndrome exacerbation [neurometabolic] FluMist Musculoskeletal and
connective tissue (24) Ankylosing spondylitis
[rare arthritis] Gardasil/Gardasil 9 Arm pain Engerix-B, Vaqta Arthralgia [joint
pain] Adacel, Bexero, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Gardasil/Gardasil 9, Havrix, MMR-II, Menactra, Menomune, Menveo, Prevnar-13, Recombivax, Tenivac, Trumenba, Twinrix, Varivax Boostrix, Engerix-B, Gardasil/Gardasil 9, IPOL, Menomune, Menveo, MMR-II, Pneumovax-23, ProQuad, Recombivax, Tdvax, Twinrix Arthritis Gardasil/Gardasil 9,
MMR-II Engerix-B, Flulaval,
MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix Arthropathy Gardasil/Gardasil 9 Back pain Engerix-B, Fluarix, Gardasil/Gardasil 9, Pneumovax-23, Recombivax, Twinrix, Vaqta Boostrix Bone pain Menveo Cramps Engerix-B, Recombivax Hip and wrist fracture Tenivac Hypotonia [low
muscle tone] Pentacel Daptacel, Hiberix,
Infanrix, Pediarix, Prevnar-13, Quadracel Invertebral disc
protrusion Menactra Muscle spasm Adacel Muscle
weakness/weakness Adacel, Engerix-B, Recombivax, Tenivac, Twinrix Engerix-B, Flulaval, Recombivax, Twinrix Musculoskeletal pain Fluarix ProQuad Musculoskeletal
stiffness Havrix Myalgia [muscle pain] Adacel, Afluria, Bexero, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menveo, MMR-II, Pneumovax-23, Quadracel, Recombivax, Trumenba, Twinrix, Vaqta, Varivax Boostrix, Gardasil/Gardasil 9, IPOL, Menactra, Menomune, MMR-II, ProQuad, Tdvax, Tenivac Myositis [muscle
inflammation] Adacel Neck pain Engerix-B, Fluarix,
Pneumovax-23, Recombivax Pain in extremities Fluarix, Fluzone,
Pediarix, Recombivax, Tdvax, Tenivac Psoriatic arthropathy Gardasil/Gardasil 9 Reactive arthritis Gardasil/Gardasil 9 Shoulder pain Engerix-B, Recombivax Stiff neck Recombivax, Varivax Stiffness Pneumovax-23, Vaqta,
Varivax Nervous system (45) Acute disseminated
encephalomyelitis (ADEM) Menveo, MMR-II Gardasil/Gardasil 9,
Menactra, MMR-II, ProQuad Ataxia [nervous
system dysfunction] MMR-II MMR-II, ProQuad,
Varivax Bulging fontanelle Pediarix Cerebellar ataxia Vaqta Convulsions/seizures ActHIB, Daptacel, Havrix, Hiberix, Infanrix, Menactra, Menomune, Menveo, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, RotaTeq ActHIB, Adacel, Afluria, Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, IPOL, Kinrix, Menactra, MMR-II, Quadracel, Recombivax, Tdvax, Twinrix, Varivax Depressed level of
consciousness Boostrix, Pediarix,
Pentacel Dizziness Engerix-B,
Gardasil/Gardasil 9, MMR-II, Recombivax, Twinrix Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, MMR-II, ProQuad, Tdvax, Tenivac, Varivax Encephalitis,
vaccine-induced encephalitis [brain inflammation] MMR-II Boostrix, Engerix-B, FluMist, MMR-II, Pediarix, Recombivax, Twinrix, Vaqta, Varivax Encephalomyelitis [brain
and spinal cord] Afluria, Fluarix,
Fluzone Encephalopathy [brain
disease] MMR-II, Pentacel Afluria, Engerix-B, Flulaval, Havrix, Infanrix, MMR-II, ProQuad, Twinrix Facial palsy, Bell’s
palsy Adacel, Boostrix, Engerix-B, Fluarix, FluMist, Fluzone, Menactra, Menveo, ProQuad, Recombivax, Twinrix, Varivax Facial (or cranial)
nerve paralysis Adacel Flulaval Facial paresis [impaired
facial movement] Fluarix, Menveo Febrile
convulsions/seizures Afluria, Daptacel, Fluzone, Infanrix, Hiberix, Menveo, MMR-II, Pediarix, Pentacel, Prevnar-13, ProQuad, RotaTeq, Vaqta, Varivax Afluria, Daptacel, Fluzone, IPOL, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Quadracel, Recombivax Headache Adacel, Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax DT, Gardasil/Gardasil 9, Infanrix, IPOL, Menomune, Menveo, 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 (HHE) Daptacel, Infanrix, Prevnar-13 Daptacel, Hiberix,
Kinrix, Pediarix, Pentacel, Quadracel Hypertonia Havrix Infantile spasms Daptacel, Pediarix Lethargy ActHIB, Daptacel,
FluMist, Pentacel Pediarix Limb paralysis Flulaval Measles inclusion body
encephalitis (MIBE) MMR-II MMR-II, ProQuad Migraine Adacel, Fluarix,
Twinrix Engerix-B, Recombivax Motor neuron disease Gardasil/Gardasil 9 Myelitis [spinal
cord disease] Adacel, Fluarix,
Fluzone, Havrix, Recombivax, Twinrix Nerve compression Adacel Neuralgia [nerve
pain] Afluria Neuritis (including
brachial, polyneuritis) MMR-II Adacel, Afluria, Engerix-B, Fluarix, Fluzone, MMR-II, Twinrix Neuropathy,
polyneuropathy MMR-II Afluria, Engerix-B, Fluarix, Havrix, MMR-II, ProQuad, Recombivax, Twinrix Numbness Varivax Paralysis Engerix-B,
Gardasil/Gardasil 9, Twinrix Paresis [partial
paralysis] Engerix-B, Twinrix Paresthesia [abnormal
skin sensations] MMR-II, Recombivax,
Twinrix Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, IPOL, Menactra, Menomune, MMR-II, Pneumovax-23, ProQuad, Tenivac, Varivax Partial seizures,
seizures Menveo Daptacel, Engerix-B,
ProQuad Presyncope [feeling
faint] Flucelvax Radiculopathy [“pinched
nerve” in spine] Pneumovax-23 Pneumovax-23, Recombivax Somnolence Engerix-B, ProQuad,
Twinrix Daptacel, DT, Flulaval,
Havrix, Hiberix, IPOL, Pediarix, Pentacel, Quadracel, Recombivax Subacute sclerosing
panencephalitis (SSPE) MMR-II MMR-II, ProQuad Syncope, vasovagal
syncope [fainting] Flublok, MMR-II,
Twinrix Adacel, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Menomune,
Menveo, MMR-II, Pediarix, ProQuad, Recombivax, Tenivac, Trumenba Tingling Engerix-B Tonic convulsions Menveo Menveo Transverse myelitis MMR-II Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Menactra, MMR-II, ProQuad, Recombivax, Twinrix, Varivax Tremors Pneumovax-23 Flulaval, ProQuad Unresponsiveness Daptacel Psychiatric (15) Agitation Engerix-B, Twinrix IPOL, ProQuad,
Recombivax Anorexia ActHIB, Daptacel,
Havrix, Engerix-B, IPOL, Menactra, Menomune, Twinrix, Vaqta Crying (abnormal,
unusual, persistent or inconsolable) ActHIB, Daptacel, DT, Flulaval, Fluzone, Hiberix, Infanrix, IPOL, Menactra, Menveo, PedVaxHIB, Pentacel, Prevnar-13, Vaqta Pediarix Decreased sleep Prevnar-13 Depression Pneumovax-23 Disturbed sleep Recombivax, Varivax Fretfulness Daptacel Fussiness ActHIB, Daptacel,
Hiberix, Infanrix, IPOL, Pediarix, Pentacel Hypersomnia ProQuad Increased sleep Prevnar-13 Insomnia Engerix-B, Gardasil/Gardasil 9, Havrix, Recombivax, Twinrix, Vaqta Flulaval, Pediarix Irritability ActHIB, Afluria, , Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Menactra, Menomune, Menveo, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq, Twinrix, Vaqta, Varivax MMR-II, Recombivax Nervousness Varivax Pediarix, ProQuad Restlessness Hiberix Pediarix Screaming Daptacel, Pediarix,
Pentacel, Quadracel Reproductive (2) Dysmenorrhea Fluarix Menstruation disorders Vaqta Respiratory, thoracic
and mediastinal (19) Apnea ActHIB, Daptacel Engerix-B, Hiberix, Infanrix, Kinrix, Pediarix, Pentacel, Prevnar-13 Asthma, asthma-like
symptoms Daptacel, FluMist, Gardasil/Gardasil 9, Pediarix, Pentacel, Tenivac, Vaqta Engerix-B, Fluarix,
Twinrix Asthmatic crisis Gardasil/Gardasil 9 Bronchial constriction Vaqta Bronchial
hyperreactivity Havrix Bronchospasm, bronchial
spasm Daptacel,
Gardasil/Gardasil 9, MMR-II, Prevnar-13, RotaTeq Engerix-B, Fluarix, Flulaval, Gardasil/Gardasil 9, MMR-II, ProQuad, Recombivax, Tenivac, Twinrix Cough Afluria, Fluarix, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, FluMist, MMR-II, ProQuad, Recombivax, Rotarix, Vaqta, Varivax Fluarix, Fluzone,
Infanrix, MMR-II, Pediarix, Pentacel Cyanosis* [bluish
discoloration, low oxygen] Daptacel, Hiberix,
Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel Difficulty breathing Menactra Dyspnea [shortness
of breath] Prevnar-13 Fluarix, Flulaval, Fluzone, Havrix, Menomune, Pediarix, Quadracel, Twinrix Dysphonia [vocal
abnormalities] Flulaval Hypoxia Daptacel, FluMist Oropharyngeal pain Afluria, Flucelvax,
Flulaval, Gardasil/Gardasil 9 Fluzone, Menveo Respiratory distress Havrix Fluarix Rhinorrhea [runny
nose] Afluria, Fluarix, Flulaval, FluMist, Fluzone, HepB, MMR-II, ProQuad, Rotarix, Vaqta, Varivax Fluzone Stridor [high-pitched
wheezing] Fluarix Throat tightness Flulaval, Fluzone Upper airway swelling Menactra Wheezing FluMist, Menveo, Vaqta Fluzone, Menactra,
ProQuad Skin/ subcutaneous
tissue (33) Acute hemorrhagic edema
of infancy MMR-II MMR-II, ProQuad Alopecia [hair loss] Gardasil/Gardasil 9 Engerix-B, Recombivax, Twinrix Contact rash Varivax Dermatitis Vaqta, Varivax Diaper rash Varivax Dry skin Varivax Eczema Varivax Engerix-B, Recombivax,
Twinrix Erythema [skin
redness] ActHIB, Adacel,Afluria, Bexero, Engerix-B, Flucelvax, Fluzone, IPOL, Menactra, Menveo, PedVaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Twinrix,
Vaqta, Varivax Fluarix, Infanrix, Menactra, Menveo, MMR-II, Pediarix, Pentacel, Tdvax Erythema multiforme [skin
disorder] Flucelvax, MMR-II, Prevnar-13 Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Prevnar-13, Recombivax, Twinrix, Varivax Erythema nodosum [nodules
or lumps] Gardasil/Gardasil 9 Engerix-B, Recombivax,
Twinrix Exanthem/viral
exanthema [widespread rash] ProQuad, Vaqta Boostrix Facial swelling/edema Prevnar-13 Daptacel, Fluarix, MMR-II, ProQuad, Varivax Heat rash 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 MMR-II, ProQuad Parotitis [salivary
gland inflammation] MMR-II MMR-II, ProQuad Pigmentation disorder Gardasil/Gardasil 9 Pruritus [itchy skin] Afluria, Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax ActHIB, Adacel, Afluria, Boostrix, Daptacel, Fluarix, Flucelvax, Flulaval, Fluzone, Infanrix, Kinrix, Menactra, Menomune, Menveo, MMR-II, Prevnar-13, ProQuad, Tdvax, Tenivac Psoriasis Gardasil/Gardasil 9 Purpura [red/purple
spots] MMR-II Engerix-B, MMR-II,
ProQuad Pustular psoriasis Gardasil/Gardasil 9 Rash Adacel, Afluria, Engerix-B, Flublok, Flulaval, Havrix, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Twinrix, Vaqta, Varivax ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Menomune, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Tdvax, Tenivac Rash morbilliform Vaqta Rash vesicular ProQuad, Vaqta Skin discoloration Pentacel Skin exfoliation Menveo Skin induration MMR-II, ProQuad Stevens-Johnson
syndrome [severe skin reaction] Gardasil/Gardasil 9,
MMR-II Engerix-B, Fluarix, Fluzone, MMR-II, ProQuad, Recombivax, Varivax Sweating Engerix-B, Fluarix,
Flucelvax, Pneumovax-23, Recombivax, Twinrix Vesiculation MMR-II Vitiligo Gardasil/Gardasil 9 Vascular (10) Cerebrovascular
accident Kinrix, Pneumovax-23,
Tenivac ProQuad, Varivax Deep venous thrombosis Gardasil/Gardasil 9 Flushing Engerix-B, Recombivax,
Twinrix Flulaval, Fluzone Henoch-Schönlein
purpura [blood vessel inflammation] MMR-II Boostrix, Fluarix,
MMR-II, ProQuad, Varivax Pallor DT, Flulaval, Hiberix,
Pediarix, Pentacel, Prevnar-13, Quadracel Petechiae [bleeding
capillaries] Engerix-B, Twinrix Pediarix, Recombivax Polyarteritis nodosa [damaged
arteries] Recombivax Raynaud’s phenomenon Gardasil/Gardasil 9 Renal vasculitis Afluria Vasculitis MMR-II Afluria, Engerix-B,
Fluarix, Fluzone, Havrix, MMR-II, Recombivax, Twinrix Urogenital (6) Dysuria [difficult
urination] Recombivax Epididymitis [testicular
inflammation] MMR-II MMR-II, ProQuad Orchitis [inflammation
of the testes] MMR-II MMR-II, ProQuad Proteinuria Gardasil/Gardasil 9 Urinary retention Pneumovax-23 Urinary tract infection Gardasil/Gardasil 9,
RotaTeq
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