11 Vaccine Myths That Just Refuse To Die: Debunked
3. Myth: Vaccine Inserts Prove They Don't Work
We’ve spoken about vaccine safety studies, ingredients, and herd immunity. We haven’t spoken vaccine inserts.
Anti-vaxxers who steadfast believe that vaccines are the cause of every illness, disease, and condition will often cite vaccine package inserts, VAERS (Vaccine Adverse Event Reporting System), or the NVICP as their supporting evidence, mostly because they contain big scary warnings, regardless of how rare the side effects are.
A package insert is a legally mandated document that must be created and distributed for all medications. It is not a scientific document and, though it does discuss the results of studies, it does not include summaries of all scientific research. It provides information on how a drug is to be administered and to whom. The package insert is the manufacturer complying with federal regulations mandated by the governing bodies in countries across the globe. Details of what needs to be included on a package insert can be found here, here and here.
It is important to note the "adverse events" section of a package insert is created based on the number of reports regarding a drug and an event. There does not need to be a casual or direct relationship between the two. In fact, vaccine package insert will state this itself, “Events were included in this list because of the seriousness or frequency of reporting. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship.”
Many of these reports are taken from places such as the VAERS database, the self-reported database of adverse events that follow any vaccinations. To quote the VAERS website, “Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors.” Package inserts legally need to state that information, just in case. For further information, The Logic of Science has a more detailed analysis.
The Hulk is even mentioned on VAERS, so maybe take it with a pinch of salt.