Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

One of the cherished strategies of the antivaccine group is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other cases) to “prove” that vaccines are dangerous. Vaccine deniers consider the package insert to be golden tablets of the Truth™. It’s ironic that these antivaccine groupies rail against Big Pharma, as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. Irony abounds.

Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to a section in any of the many vaccine package inserts (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. Or that it doesn’t work.

The snarky Orac has proclaimed it “Argument by Package Insert” – it’s almost at the level of logical fallacy. David Gorski has just given it the Latin name, argumentum ad package insert, so it’s now officially a logical fallacy, at least for vaccine discussions.

Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. However, vaccine package inserts are not documents that serve as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. Continue reading “Argument by Vaccine Package Inserts – they’re not infallible”

Reports of vaccine related effects can be useful


©, 2007. Photographer's son actually receiving RotaTeq vaccine and giving a smile to Paul Offit for keeping him from ever getting a rotavirus infection.
©, 2007. Photographer’s son actually receiving RotaTeq vaccine and giving a smile to Paul Offit for keeping him from ever getting a rotavirus infection.

Vaccine deniers, especially in the USA, use the passive data from the Vaccine Adverse Event Reporting System (VAERS), a system where individuals can report supposed adverse events post-vaccination, to “prove” certain adverse events. The data is considered to be “passive” because the individual reports can be made online, by fax or by mail–real causal events may be underreported and hyped, imaginary issues with no causality, can be over-reported. However, without medical investigations of causality between the vaccination and the claimed adverse events that are reported to the VAERS database, the data have no real value.

Frankly, VAERS can be gamed by those with nefarious intentions. In reality, VAERS is a feel-good system for those who think that there’s a link between vaccines and something terrible, but without an active investigation, the data is just above the level of being totally meaningless. Most epidemiologists know it is valueless. Even the VAERS system itself says that the data cannot be used to ascertain the difference between coincidence and true causality.

Furthermore, there is a background rate for mortality (death) or morbidity (abnormal medical condition), across all causes, irrespective of whether an individual is vaccinated or not, and unless you understand the background rate, the vaccine “mortality” rate has no scientific meaning. In fact, we could provide data that shows anything might cause any adverse medical event, like playing video games leads to prostate cancer, but we would have no evidence of any type of causality whatsoever. Continue reading “Reports of vaccine related effects can be useful”