This Fact Sheet may have been updated. For the most recent Fact Sheet for Recipients and Caregivers, a copy of which is being provided to you with this informed consent. Current copies of the Fact Sheet are available online at https://www.modernatx.com and you should look here for updates.
The vaccine may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19. The FDA has authorized the emergency use of this vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA Note that pregnant and breastfeeding of women have not been included in clinical trials for the COVID-19 vaccine and the CDC Fact Sheet does not discuss any specific risks to these patients. Although theFDAoffersuse the vaccine for pregnant and breastfeeding women, the potential side effects are unknown at this time. Potential side effects to the mother, neonate or infant may include: miscarriage; birth defects; and serious injury or death to breastfeeding infants.
The vaccine will be given to you as an injection into the muscle. The vaccine is given in a series of 2 doses given 4 weeks apart. If you receive one dose of the vaccine, you should receive a second dose of this same vaccine 4 weeks later to complete the vaccination series.
Risks of the vaccine include side effects and there is a chance that the vaccine could cause a severe allergic reaction. If you experience a severe allergic reaction, call 9-1-1, or go tothe nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.