In regards to vaccines, the 1986 Act passed by Congress requires health care providers give patients a copy of the vaccine manufacturer insert. Unfortunately, the emergency-use COVID-19 vaccine inserts are blank. However, you should still be informed of the risks. If you were not, file a complaint.
Familiarize yourself with the reported injuries and deaths from the HHS Vaccine Adverse Events Reporting System.
Read about the risks at the Citizens Council for Health Freedom website www.realrisks.org.
What are your rights when receiving…
- Emergency Use Authorization pandemic vaccines (ex: COVID-19, Ebola 2016, H1N1 2009, Anthrax 2005):
…unlike federal law that requires vaccine providers to inform patients of the risk/benefit associated with routine childhood vaccines, federal law governing EUA vaccines is silent on who is responsible for providing this information to EUA vaccine recipients and when it must be provided. The FDA’s website states that individuals receiving EUA vaccines must be informed that they have the right to accept or refuse the vaccine, and be made aware of any alternative product. The FDA also states that this information is typically included in the patient “fact sheet” posted on the FDA’s website. Federal law governing EUA vaccines provides that vaccine recipients must be informed of the following information:
- the vaccine is authorized for emergency use;
- the significant known and potential risks and benefits of use;
- the extent to which risks and benefits are unknown;
- the option to accept or refuse the vaccine, and the consequences of refusal, if any; and
- available alternatives to the vaccine, and their risks and benefits.
- *****more information on Seniors and the Disabled, Long-Term Care Ombudsman Program, and Military can be found at the same link: https://www.nvic.org/faqs/emergency-use-vaccines.aspx
- FDA-approved, non-pandemic vaccines (ex: DTaP, Hepatitis B, MMR)
- give parents vaccine benefit and risk information before vaccination (CDC Vaccine Information Statements – VIS);
- report serious health problems, injuries, hospitalizations and deaths following vaccination to a centralized federally operated Vaccine Adverse Event Reporting System (VAERS);
- write down serious health problems following vaccination in the individual’s permanent medical record; and
- keep a permanent record of vaccinations given, including manufacturer’s names and lots numbers. NVIC worked with Congress to get these important safety provisions passed within this historic law.