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?