COVID-19 Vaccine Safety in Long-Term Care Facilities

What LTCF Administrators Should Know

COVID-19 vaccines are being held to the same safety standards as all other vaccines.

The federal government has been working since the pandemic began to make one or more COVID-19 vaccines available as soon as possible while ensuring they are safe and effective through the U.S Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority.

COVID-19 vaccines were tested in large studies that included tens of thousands of people to make sure they meet safety standards and protect people of different ages, races, and ethnicities. The study results showed that the vaccine’s benefits outweighed possible risks and provided protection from COVID-19.

Once people receive COVID-19 vaccinations, CDC and the FDA will use existing robust systems and data sources to continue monitoring vaccine safety closely. An additional layer of safety monitoring has also been added that allows CDC and FDA to evaluate COVID-19 vaccine safety almost immediately. Learn more about COVID-19 vaccine safety monitoring.

Special Considerations

Although very rare, there have been reports of a few severe allergic reactions (for example, anaphylaxis) in people who have received a COVID-19 vaccine. LTCF staff should be aware of the potential for a severe allergic reaction and have the necessary equipment and medications on hand if a severe allergic reaction occurs. Staff should also be aware of the signs and symptoms of anaphylaxis.

How to prepare for possible severe allergic reactions (anaphylaxis) in vaccine recipients

  • Staff should be aware of nursing home protocols for emergency care for residents with a severe allergic reaction.
  • Have epinephrine (an EpiPen™) available for use, if needed.
  • If epinephrine is used, dial 911 immediately.

You should review contraindications and precautions to COVID-19 vaccination before vaccination.  However, If someone has ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine or to polysorbate, which is closely related to a vaccine ingredient called “polyethylene glycol” (PEG), CDC recommends they should not get COVID-19 vaccine. People should be observed for either 15 or 30 minutes after vaccination, depending on history of previous allergic reactions. All other people should be observed for 15 minutes. Detailed information on CDC recommendations can be found in the Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.

For more information, check the following websites:

Ways to Monitor COVID-19 Vaccine Safety

V-safe

CDC encourages everyone who receives a COVID-19 vaccination enroll in v-safe. V-safe is a new smartphone-based tool that helps CDC monitor the safety of COVID-19 vaccines through the use of text messaging and web surveys. These health check-ins allow you to tell CDC how you are feeling after receiving a dose of COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you.

V-safe will also provide reminders to get a second dose of COVID-19 vaccine if you need one. Keep in mind that v-safe cannot schedule vaccination appointments. If you need to schedule, reschedule, or cancel a COVID-19 vaccination appointment, contact the location that set up your appointment or a local vaccination provider. V-safe enrollment and check-ins are quick and easy and can all be done on a smartphone.

  • All LTCF staff members vaccinated against COVID-19 are encouraged to enroll in v-safe.
  • At this time, only people with smartphones will be able to participate in v-safe. LTCF residents may be less likely to have access to a smartphone and, therefore, may not be able to report side effects or adverse events through v-safe.
  • LTCF residents can enroll themselves in v-safe. Healthcare providers and caregivers may assist residents with enrolling, but they should not complete check-ins for residents.
  • Everyone who gets a vaccine should be given a v-safe information sheetpdf icon at the time of vaccination. The sheet provides instructions on how to register and get started. For v-safe resources, also available in languages other than English, visit the v-safe Print Resources web page. If a vaccine recipient was not given the v-safe information sheet, the v-safe registration instructions are available online.

VAERS

Long-term care facility healthcare providers and healthcare staff will play a key role in educating LTCF residents, administrative staff, caregivers, and other staff members about COVID-19 vaccine safety and reporting possible side effects after COVID-19 vaccination.

Facility administrators should work with staff to report any health problems that occur after vaccination to the Vaccine Adverse Event Reporting System (VAERS)external icon, even if you are unsure the vaccine caused the health problem. VAERS is a national vaccine safety monitoring system that helps CDC and FDA monitor health problems after vaccination. VAERS collects and reviews reports of possible side effects (adverse events) that occur after vaccination. While VAERS does not determine whether the vaccine caused the event, it can determine if further investigation is needed.

In general, report any side effect or health problem after COVID-19 vaccination that is concerning to you, your staff, or your residents to VAERS. It is especially important to report any problem that results in hospitalization, significant disability, or death. In most cases, some discomfort from pain and swelling in the arm where the vaccine was given is normal after COVID-19 vaccination. Headache, fever, chills, or tiredness may also occur. However, notify the nursing staff:

  • If the redness or tenderness where the resident got the shot increases after 24 hours or
  • If the side effects are concerning or do not seem to be going away after a few days.

See more information on potential side effects.

Healthcare providers are required to report to VAERS the following adverse events, in accordance with the emergency use authorization (EUA) for COVID-19 vaccines:

  • Vaccine administration errors, whether or not associated with an adverse event
  • Serious adverse events (as defined by federal law), regardless of causality, including:
    • death
    • a life-threatening event
    • inpatient hospitalization or prolongation of existing hospitalization
    • persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • congenital anomaly/birth defect
    • an important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
  • Cases of Multisystem Inflammatory Syndrome (MIS)
  • Cases of COVID-19 that result in hospitalization or death

Learn more about what to report to VAERSexternal icon.

Anyone can submit a report to VAERS.

  • Residents, caregivers, healthcare providers, and nursing home staff can report an adverse event following COVID-19 vaccination to VAERS.
  • Residents, family members, or caregivers are encouraged to immediately contact 911 if there is a serious adverse event or emergency. Healthcare providers and LTCF staff can assist in the VAERS reporting process.
  • Facilities using the National Healthcare Safety Network (NHSN) to track vaccine uptake can also be connected to VAERS through NHSN.
  • For more information, please visit the VAERSexternal icon website.

For more information on how vaccine safety is monitored in the U.S., visit CDC’s website on Ensuring the Safety of COVID-19 Vaccines in the United States.

Vaccine Safety Monitoring for Long-Term Care Facility Staff and Caregivers

Vaccine Safety Monitoring for Long-Term Care Facility Staff and Caregivers: VAERS

If you’re a certified nursing assistant or other caregiver in a long-term care facility, this video on the Vaccine Adverse Event Reporting System (VAERS) is for you! Learn what VAERS does and how you can help medical staff report any concerning side effects in residents following COVID-19 vaccination. Learn about common side effects after COVID-19 vaccination and what you need to report to VAERS.

Additional Vaccine Safety Resources
How to submit a report to VAERS: https://vaers.hhs.gov/reportevent.htmlexternal icon
What to report – full requirements: https://vaers.hhs.gov/faq.htmlexternal icon

Vaccine Safety Monitoring for Long-Term Care Facility Staff and Caregivers: v-safe

If you’re a certified nursing assistant or other caregiver in a long-term care facility, this video on v-safe is for you! Learn how to register and get started with v-safe — CDC’s after vaccination health checker. Use your smartphone to tell CDC about any side effects after getting the COVID-19 vaccine. You’ll also get reminders if you need a second vaccine dose. Both you and your residents are encouraged to participate.

Additional Vaccine Safety Resources
How to register and get started with v-safe: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html
Frequently asked questions about v-safe: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/faq.html

Page last reviewed: March 10, 2021