Talking Point #16 - Package Inserts & Excipient Lists vs. Vaccine Information Statement (VIS) Sheets

Which one did your doctor provide?

October is Vaccine Injury Awareness Month, and with Alexis Lorenze’s story of vaccine injury going viral on social media, it’s time to update the VaxSafety.org website, this Substack, and my new Instagram! I’ll be posting 60 talking points that break this conversation into easily digestible parts, making it accessible for everyone, even kids. So, let’s put on our black ribbons for awareness and spread the word. Feel free to share widely, and check back anytime for updates, as I’ll be adding more information as needed.

Did you know that you have a right to look at the vaccine package insert before you or your child is injected with a vaccine? The vaccine package insert is a folded page with tiny print that is included inside the box with the vial. It has useful information like adverse reactions, clinical study results, contraindications, and more. This is part of the informed consent process discussed in a previous talking point.

This is a Package Insert…

Remember, a vaccine package insert is NOT what your doctor hands you at the time of your baby’s shots. That 8.5" x 11” printed white sheet is called a Vaccine Information Statement (VIS) sheet. The CDC provides it for doctors to hand out at appointments, but it is NOT a complete vaccine package insert. It does not provide enough information to make a truly informed decision.

These are NOT Package Inserts…

Some doctors claim that they cannot give you the vaccine package insert because it needs to remain with the vial. If you want the original insert, you can request that the doctor/nurse save inserts from finished vials and mail them to you or save them for you to collect at a later date. However, you can print package inserts or view them online before your appointment at the link below. It’s helpful to ask your doctor which vaccines will be given and their brand. See the list of vaccines licensed for use in the United States at the link below.

Let us not forget when the COVID-19 vaccine package insert was left intentionally blank…

Did you know the vaccine ingredients are NOT on the vaccine package insert? You have a right to review that information, too. You can ask your doctor to reference their CDC Pinkbook Appendix B, or print it from the CDC website below. After reviewing the package insert and the ingredients (excipient) list, you’ll be well on your way to making an informed decision.

Here is what the list of ingredients looks like…

Resources:

The Real Vaccine Inserts (kept with the vial): https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

The Vaccine Information Statement (the printed sheet your doctor hands you): https://www.cdc.gov/vaccines/hcp/vis/current-vis.html

Vaccines Licensed for use in the United States: https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

The Ingredients List or Exipient List (not included in the package insert): https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf