What Is a Vaccine Insert?
Every vaccine that is licensed by the FDA comes with a package insert that is 12-20 pages long, which includes everything from ingredients, warnings and precautions, contraindications, adverse reactions gathered from clinical trials and post-marketing surveillance.
However, healthcare providers are only legally obligated (through Federal law) to provide you with a one-page vaccine information sheet (VIS) before the vaccine is administered.
Physicians do not always follow the recommendations of the manufacturers: for example, the Boostrix vaccine insert recommends at least 5 years between repeated Tdap administration, but obstetricians will recommend a pregnant woman to get a Tdap every pregnancy, even if her pregnancy was only a year or two after her previous pregnancy. This is one reason why everyone should read the Vaccine Inserts.