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Read the Fine Print, Part Two—Nearly 400 Adverse Reactions Listed in Vaccine Package Inserts

By the Children’s Health Defense Team | Children's Health Defense

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 Ahepatitis BinfluenzaPrevnar-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

of Vaccine

Brand Name


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


Table 2. Clinical trial and post-marketing adverse events reported in vaccine package inserts, by body system

Body System

Medical Disorder

Reported in Clinical

Reported Post-marketing

Allergic (6) Allergic reactions/
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
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
Gardasil/Gardasil 9
Diabetes mellitus
Gardasil/Gardasil 9, Pediarix, Pneumovax-23
Gardasil/Gardasil 9
Guillain-Barré syndrome
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,
Rotarix, RotaTeq
Lupus-like syndrome Recombivax
Multiple sclerosis (or
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
Gardasil/Gardasil 9 Recombivax
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
Anemia (aplasic or
Gardasil/Gardasil 9,
Pneumovax-23, ProQuad, Varivax
Epistaxis [nosebleed] FluMist, ProQuad
Extravasation [blood
vessel leakage
Hematochezia [bloody
RotaTeq ProQuad, Rotarix,
Hemorrhage Gardasil/Gardasil 9
Increased erythrocyte
sedimentation rate
Leukocytosis [increased
white blood cells
MMR-II MMR-II, Pneumovax-23
lymph nodes
Adacel Boostrix, Pneumovax-23,
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
thrombocytopenic purpura (ITP) [low platelets]*
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
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
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,
Cerebral hemorrhage Gardasil/Gardasil 9
Gardasil/Gardasil 9
immunodeficiency and sepsis
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
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,
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
Suicide Gardasil/Gardasil 9
Traumatic brain
injury/cardiac arrest
Gardasil/Gardasil 9
Unexplained sudden
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
Afluria, Fluarix,
PedVaxHIB, RotaTeq, Vaqta, Varivax
Tinnitis Engerix-B, Recombivax,
Vertigo Havrix, Recombivax,
Engerix-B, Fluarix,
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
Ocular hyperemia [eye
Ocular palsies [nerve
neuritis/neuropathy, papillitis [optic nerve inflammation]
Gardasil/Gardasil 9,
Engerix-B, Fluzone,
MMR-II, ProQuad, Recombivax, Twinrix
Photophobia [light
Havrix Flulaval
Retinitis, necrotizing
Retrobulbar neuritis [nerve
MMR-II, ProQuad
Uveitis [eye
Gardasil/Gardasil 9 Recombivax
Visual disturbances Engerix-B, Recombivax,
Gastrointestinal (21) Abdominal pain,
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
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
Dyspepsia [indigestion] Pneumovax-23,
Engerix-B, Twinrix
Dysphagia [swallowing
Gastroenteritis Flulaval, Gardasil/Gardasil 9, Kinrix, Menveo, Pediarix, Pentacel, Prevnar-13, Rotarix, RotaTeq, Vaqta Rotarix, RotaTeq
Inflammatory bowel
Gardasil/Gardasil 9
Inguinal hernia Menactra
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
Teething Afluria, Vaqta, Varivax
Ulcerative colitis Gardasil/Gardasil 9,
Vitello-intestinal duct
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,
General and injection
site (35)
Abnormal gait Flulaval
Apathy ProQuad
Asthenia [fatigue,
Hiberix, Pneumovax-23,
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,

Posted by…

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield, Massachusetts and New England (USA) & “virtually” the world. He can also be reached at romayasoundhealthandbeauty@gmail.

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