One of the cherished strategies of anti-vaxxers is to quote vaccine package inserts to “prove” that vaccines are dangerous. These vaccine deniers consider the package insert to be the golden tablets of the Truth™.
Yes, it is ironic that these anti-vaccine groupies rail against Big Pharma as if they are demon reptilians, but the package insert (known as a PI), written by Big Pharma, is considered gospel. And there is another broken irony meter.
The most misinterpreted and misused section of vaccine package inserts is “Adverse Reactions.” The FDA states that the section should include events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” The keyword is “believe”, instead of based on evidence.
And frankly, any reaction supported by serious and robust evidence would be in the Warnings section, so the Adverse Reactions section is a laundry list of observed events that probably have nothing to do with the drug (or vaccine) but remain there so that the pharmaceutical company is covered in case of a lawsuit. Yes, pharmaceutical companies are constantly frightened of litigation, and the package insert is often the first line of defense against those frequent lawsuits.
