Vaccine Safety

The Food and Drug Administration is responsible for making sure that any authorized vaccines are safe and that they work. This process can take many months, but because of an unprecedented scientific effort, financial support and willing volunteers, researchers were able to test the vaccine on large groups of people much faster than ever before.

Potential Side Effects

When you receive the vaccine, your immune system starts to ward off COVID-19. This can cause some side effects. The majority of patients have had mild side effects. A few patients have experienced moderate reactions.

You may see reactions in the immediate area of where you receive your shot. This includes redness, swelling and pain. Other side effects include fever, fatigue, headache, chills, vomiting, diarrhea and muscle or joint pain. In general, these side effects are like having a flu-like illness. There may be other reactions that are not currently known.

While the side effects can be uncomfortable, it is necessary for you to get both doses of the vaccine. Skipping the second dose will greatly reduce your protection from COVID-19.

You’ll receive information about potential side effects at the time of your vaccination.

Reporting reactions or side effects

The Vaccine Adverse Event Reporting System collects information on reported side effects. Healthcare providers use the system to report vaccination side effects.

Patients and caregivers should report adverse events as well. Even if you are unsure that the vaccine caused the adverse event, we encourage you to report them in any case.

  • If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
  • Call your health care provider if you have any side effects that bother you or do not go away.
  • Report vaccine side effects to the Vaccine Adverse Event Reporting System (VAERS). You can also call them toll-free at 1-800-822-7967. Please specify which vaccine you received in the first line of box #18 of the report form:
    • Moderna COVID-19 Vaccine EUA or
    • Pfizer COVID-19 Vaccine EUA
    • Johnson & Johnson COVID-19 Vaccine EUA

V-Safe

V-safe is a CDC smartphone app that monitors the safety of COVID-19 vaccines. You’ll receive text messages and daily symptom surveys to see how you’re feeling after your vaccination. V-safe will remind you to get your second dose if needed. The CDC will follow-up by telephone if you report a significant adverse event. Learn more and register for the app on the CDC website.

Reporting to Manufacturers

  • Moderna vaccine: Report side effects at 1-866-MODERNA (1-866-663-3762).
  • Pfizer vaccine: Report Pfizer side effects online or at 1-800-438-1985.
  • Johnson & Johnson: Report side effects at 1-800-565-4008.
Getting a COVID-19 Vaccine

important things to know

Getting a COVID-19 Vaccine

Information on potential side effects, how to report side effects to and other things to keep in mind.

Dr. Michael Lauzardo Answers Questions About Vaccine Safety and Effectiveness

Dr. Lauzardo Discusses Side Effects

Listen to UF Health expert Dr. Michael Lauzardo discuss current side effects from the vaccine trials.

Common Questions about vaccine safety

If I get a vaccine, do I still need to wear a mask and practice physical distancing?

Yes. Vaccines may boost your immune system, so it is ready to fight the virus if you are exposed, but it is not yet fully understood whether vaccinated people might still be able to transmit the virus. Initially, we will not have enough supplies globally to vaccinate everyone who wants the vaccine, and the virus will still be transmitted. It is important for you to continue wearing a mask and following other precautions, such as practicing physical distancing and frequently washing your hands, to help reduce your chance of being exposed to and spreading the virus.

How do you counsel people to feel safe about the vaccine?

Can children get the COVID-19 vaccine?

In early clinical trials, all participants were at least 18 years of age. At this time, the COVID-19 Pfizer vaccine is not recommended for children under the age of 16. There are current studies looking at the effects of the vaccine on children between the ages of 12 and 16. More information will be available from vaccine manufacturers and the CDC in the future.

Who should I contact if I have questions about whether to receive the vaccine?

You should contact your primary care physician to discuss your concerns. Additionally, the State of Florida has set up a 24-hour hotline that is dedicated to answer your questions or concerns about the vaccine. The number is 866-779-6121. The call center is open 24 hours a day, 7 days a week.

What is Emergency Use Authorization?

The FDA can issue an Emergency Use Authorization (EUA). These are issued for public health emergencies. For the FDA to issue an EUA for COVID-19 vaccines, safety and effectiveness of the product must be demonstrated through a phase 3 clinical trial, and certain criteria must be met, including that there are no approved and available alternatives. The FDA has approved EUAs for the Pfizer-BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines.


CDC Information

Vaccine Testing and the Approval Process

The Centers for Disease Control and Prevention offer resources describing how vaccine development and testing occur.

COVID 19 Testing in the Emerging Pathogens Institute



COVID-19 Vaccines for Pregnant or Nursing Women

The effectiveness of preventing COVID-19 is expected to be the same in pregnant women as other people. If you are pregnant, your exposure to COVID-19 and the number of cases in your community are important to consider when getting vaccinated. Pregnant women are vulnerable to more severe illness from COVID-19 compared to nonpregnant women of reproductive age. Although no information from human pregnancies has been reported yet, information from animal pregnancy safety studies is reassuring. 

Are the vaccines safe for women who are nursing?

The Pfizer and Moderna vaccines are considered low-risk for breastfeeding individuals or their children. Women who are nursing will be offered COVID-19 vaccination based on the same priority groups as others. 

Are the vaccines safe for women who want to become pregnant?

COVID-19 vaccination is recommended for women considering or trying to become pregnant. Pregnancy testing is not recommended prior to vaccination. If you become pregnant after the first dose, the second dose should still be taken. If you are trying to get pregnant, consider signing up for the CDC V-SAFE registry so you can report if you become pregnant within 30 days of vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

COVID-19 Vaccines & Allergies

It is important to let the vaccination team know about your allergies because you will be monitored for 30 minutes for a potential reaction. All vaccination teams have trained personnel and are equipped with medications and protocols to handle a severe reaction. Consult with your doctor about receiving the vaccine if you have additional questions. People with a history of immediate or severe reactions to medications or vaccines should consider the following:

If I have an egg or gelatin allergy, can I get an mRNA COVID-19 vaccination (Pfizer or Moderna)?

Neither vaccine contains eggs or gelatin; thus, persons with allergies to these substances should be able to get vaccinated. Consult with your doctor about receiving the vaccine if you have additional questions.