Vaccine Safety Monitoring and Reporting in Your Facility
For LTCF administrators and clinical leadership
Even though they have been developed and released on a very accelerated timeline, 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 individuals begin receiving 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.
Although very rare, there have been reports of a few severe allergic reactions (for example, anaphylaxis) in individuals who have received a COVID-19 vaccine.
CDC considers a history of severe allergic reaction to vaccines or to any injectable therapy (intramuscular, intravenous, or subcutaneous) to be a precaution but not a reason to forgo vaccination. If you have ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine, CDC recommends that you should not get that specific vaccine. People who have a history of anaphylaxis (due to any cause) should be observed for 30 minutes following vaccination. 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.
Your staff should be aware of the potential for a severe allergic reaction and have the necessary items on hand if a severe allergic reaction occurs. In addition:
- Staff should be aware of nursing home protocols for emergency care for residents with a severe allergic reaction.
- Have epi pens (epinephrine) available if needed.
- If an epi pen is used, then dial 911 immediately.
For more information, check out the following websites:
- Management of Anaphylaxis at COVID-19 Vaccination Sites
- Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites, which includes information on what should be available on site for immediate treatment, if needed
- COVID-19 Vaccines and Severe Allergic Reactions
Ways to Monitor COVID-19 Vaccine Safety
You play a key role in educating residents and long-term care facility (LTCF) staff about vaccine safety and reporting possible side effects after COVID-19 vaccination. Any side effects following vaccination can and should be reported. See more information on potential side effects.
All vaccinated LTCF staff and residents who have a smartphone can participate in v-safe. V-safe is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys to allow vaccine recipients to tell CDC how they feel after getting a COVID-19 vaccine. Depending on their answers, someone from CDC may call to check on the person. V-safe will also provide reminders to get a second dose of COVID-19 vaccine if one is needed. 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 staff will need to monitor recently vaccinated residents for any side effects and potential adverse events and report those to VAERS (see below).
- LTCF residents can enroll themselves in v-safe. Healthcare providers and caregivers may assist residents in enrolling but should not complete check-ins for residents.
- The v-safe information sheet should be given to each vaccine recipient at the time of vaccination.
- For more information, check out frequently asked questions about v-safe.
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 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. Healthcare providers should report adverse events to VAERS even if they aren’t sure if the vaccine caused the adverse event. While VAERS does not determine whether the vaccine caused the event, it can determine if further investigation is needed.
Healthcare professionals are required by law to report certain adverse events after COVID-19 vaccine.external icon For more information on how the vaccine safety is monitored in the U.S., visit CDC’s website on Ensuring the Safety of COVID-19 Vaccines in the United States.
Anyone can submit a report to VAERS.
- Residents, caregivers, healthcare providers, nursing home staff, and vaccine manufacturers can submit a report of an adverse event following vaccination to VAERS.
- Residents, family members, or caregivers are encouraged to immediately contact a healthcare provider 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 in their facility can also be connected to VAERS through NHSN.
- Healthcare providers are required by the FDA to report adverse events in accordance with requirements under a vaccine’s EUA. Reporting is encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event.