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?

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.

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.

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.

continue onto website to see vaccine package inserts

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