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It is difficult to predict what will happen with COVID-19 because there is always a risk of new kinds (variants or subvariants) of COVID-19 arising in the future.

In addition, COVID-19 is likely to be around for a long time and there’s no way to know ahead of time how getting COVID-19 disease could affect you as an individual. For example, we still don’t know why a few healthy but unvaccinated people become seriously ill or die from COVID-19, while most other healthy people either become only mildly sick or even have no symptoms when infected (asymptomatic). In addition, people with mild or even asymptomatic disease can also develop and continue suffering from Long COVID. However, once vaccinated, your body will start building immunity to the virus so you are less likely to get infected, less likely to get seriously ill if you are infected, less likely to transmit COVID-19 to others, and less likely to get Long COVID.

Staying up to date with your COVID-19 vaccines, will reduce your chances of getting COVID-19 disease and will make it more likely that even if you do get the virus, you will have only mild symptoms or none at all.

Based on evidence from clinical trials, the U.S. Food and Drug Administration (FDA) determined COVID-19 vaccines are safe and effective for preventing serious illness, hospitalization, and death for everyone aged 6 months and older.

Although the data from the most recent omicron XBB variants of COVID-19 is still uncertain, both older and more recent studies suggest the risk of developing “Long COVID” is much lower in vaccinated people than in unvaccinated people who get COVID-19.

In addition, some people who already had Long COVID after an earlier infection noted an improvement of their symptoms after they received their COVID-19 vaccine. The potential benefits of COVID-19 vaccines on Long COVID are now being studied carefully and results will hopefully be available soon.

More information on Long COVID and other long-term effects of SARS-CoV-2 infection and COVID-19 illness can be found on the CDC website.

The updated COVID-19 vaccines are also called “bivalent” (meaning having two parts) because they are made from two different kinds of the SARS-CoV-2 virus that causes COVID-19. The safety of the bivalent Moderna and Pfizer vaccines was shown using data from human studies using a slightly older bivalent vaccine. Those vaccine side effects were similar to side effects seen with the original primary vaccine series doses. No new safety concerns were identified.

The effectiveness of the updated bivalent Moderna and Pfizer vaccines now has been documented in several recent studies, including one that indicated that the vaccine containing the BA.4 and BA.5 particles against COVID-19 omicron infection were effective for up to 120 days in preventing hospitalization for COVID-19 illness.

mRNA stands for messenger ribonucleic acid.

The COVID-19 vaccines from Pfizer-BioNTech and Moderna use mRNA to cause a two-stage immune response. First, the vaccines’ mRNA teaches your cells to make a specific non-infectious COVID-19 protein. Then, this protein stimulates your immune system to respond against COVID-19. That immune response produces antibodies and other forms of immunity that help keep you from becoming infected if you are later exposed to COVID-19.

The mRNA in the COVID-19 vaccines does NOT get into the nucleus of your cells or put germs into your body. These two mRNA COVID-19 vaccines will not change your DNA or your body’s other genetic material in any way. These mRNA COVID-19 vaccines do not inject spike proteins into your body.

Additional information about the development of mRNA vaccines is available.

The Novavax COVID-19 vaccine is a non-mRNA vaccine that contains an “adjuvant” which is a chemical that amplifies the immune system’s response to the vaccine. Adjuvants have been in use for many years in a number of U.S. vaccines such as hepatitis A, hepatitis B, and TDaP (tetanus, diphtheria and pertussis / whooping cough). This Novavax vaccine uses a more traditional approach, by injecting the spike proteins of the coronavirus, stimulating the immune system to respond directly to those proteins.

Its primary vaccination series includes two doses intended to be given from 3-8 weeks apart to people 12 years and older.

Novavax study data indicated an overall 90% effectiveness in preventing infection with pre-Omicron variants of SARS-CoV-2 (including 79% effectiveness in people 65 years and older) and near 100% overall effectiveness in preventing moderate-to-severe COVID-19 disease, hospitalization, and death.

Previously, the FDA had limited the use of the J&J COVID-19 vaccine due to safety issues. However, all remaining doses of J&J/Janssen COVID-19 vaccine in the United States expired on May 6, 2023. No additional J&J COVID-19 vaccine will be produced or used.

An EUA is an “Emergency Use Authorization,” that may be issued for products that are not currently fully approved by the FDA. With an EUA, the FDA allows a vaccine and/or drug company to apply for emergency use of a COVID-19 vaccine (or COVID-19 treatment drug or a COVID-19 test) with only a limited amount of effectiveness and safety data. This temporary authorization means that the vaccine can become available for use in an emergency (like the COVID-19 pandemic) more quickly than the usual approval and licensing process by the FDA.

However, before an EUA is issued, the FDA and its outside advisory group must decide that the known and possible benefits of the proposed vaccine outweigh the possible risks of its use.

Information describing a COVID-19 vaccine’s path from initial research to an EUA - and eventually to a biological license application (BLA) - can be found on the FDA’s website.

Full approval for a vaccine requires the FDA’s standard and rigorous process for reviewing medical products, including vaccines, drugs, test kits, and other medical devices. That review process for a vaccine relies upon the manufacturer’s submission of a Biologics License Application (BLA), a comprehensive submission that is submitted to the agency and that must meet very specific requirements.

For COVID-19 vaccines, a BLA uses the early information that previously supported the EUA, such as preclinical and clinical data, as well as details of the manufacturing process. However, to ensure the safety of vaccines, the BLA generally requires a far longer period of time for observing and examining both vaccine safety and vaccine effectiveness. This BLA review is among the most comprehensive medical product reviews in the world. It involves the FDA and its external advisory committee conducting their own analyses of the information in the BLA. FDA will also inspect the facilities that are involved in manufacturing the product.

Full approval by the FDA also means the vaccine can be used in non-emergency settings.

The currently available COVID-19 vaccines are now fully approved for use in some age and risk groups while vaccine use in other groups is still covered by the earlier EUAs.

Information on the Pfizer-BioNTech COVID-19 Vaccine is available on the CDC website.

A complete list of this vaccine’s ingredients can be found in the fact sheet.

Type of vaccine: mRNA

How given: injection in the muscle of the upper arm

This vaccine does not contain: eggs, preservatives, gelatin, or latex

The Pfizer-BioNTech COVID-19 vaccine is recommended for people 6 months and older.

Information on the Moderna COVID-19 Vaccine can be found on the CDC website.

A complete list of this vaccine’s ingredients can be found in the fact sheet.

Type of vaccine: mRNA

How given: injection in the muscle of the upper arm

This vaccine does not contain: eggs, preservatives, gelatin, or latex

The Moderna COVID-19 vaccine is recommended for people 6 months and older.

All remaining doses of J&J/Janssen COVID-19 vaccine in the United States expired on May 6, 2023. After this date, the J&J/Janssen COVID-19 vaccine can no longer used in the United States.

Information on the Janssen COVID-19 Vaccine can be found on the CDC website.

A complete list of this vaccine’s ingredients can be found in the fact sheet.

Information on the Novavax COVID-19 vaccine can be found on the CDC website.

A complete list of this vaccine’s ingredients can be found in the Novavax fact sheet.

Type of vaccine: protein vaccine with adjuvant (also known as “adjuvanted protein” vaccine)

The Novavax COVID-19 vaccine does not contain: eggs, preservatives, gelatin, or latex.

How given: injection in the muscle of the upper arm

The Novavax COVID-19 vaccine may be used for people 12 years and older.

Yes. In general, COVID-19 vaccines and other approved vaccines may be administered to all age groups without regard to timing. This includes getting a COVID-19 vaccine and other vaccines on the same day, as well as co-administration within 14 days. This includes the flu, pneumococcal, tetanus, and shingles vaccine.

However, there are additional considerations if also receiving an orthopoxvirus (mpox) vaccine:

• People who previously received a dose of any COVID-19 vaccine may be given Mpox (orthopoxvirus) vaccine without a minimum interval between vaccinations.
• People who previously received Mpox (orthopoxvirus) vaccination , particularly adolescent or young adult males, might consider waiting 4 weeks before receiving a dose of any COVID-19 vaccine because of the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and COVID-19 vaccines, and the unknown risk for myocarditis and pericarditis after JYNNEOS administration.https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-Recipient-fact-sheet.pdf

Yes. Getting COVID-19 vaccine during pregnancy can protect you and your fetus and infant from getting severe illness from COVID-19.

Currently and recently pregnant people are more likely than non-pregnant people to get severely ill if they get COVID-19. Pregnant women with some underlying health conditions, such as diabetes or obesity, are at even greater risk. Having COVID-19 disease while pregnant has been associated with stillbirths, preterm birth, low birth weight babies, and other adverse outcomes of pregnancy. In addition, another study showed that infants whose mothers received two doses of COVID-19 vaccine during pregnancy were 61% less likely to be hospitalized in their first six months of life compared to infants of unvaccinated mothers.

The CDC, VDH, the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal Fetal Medicine (SMFM) all recommend that pregnant or breast-feeding women or other women who intend to get pregnant and who otherwise are eligible for COVID-19 vaccination should be COVID-19 vaccinated and then stay up to date with vaccination. The ACOG recommendations are available and a joint message about COVID-19 vaccination from ACOG and SMFM is also available.

CDC and the Food and Drug Administration (FDA) have several vaccine safety monitoring systems in place to collect and study information about vaccination during pregnancy and continue to closely monitor that information.

The safety monitoring of COVID-19 vaccines has been described as “the most comprehensive of any vaccine in US history.”

CDC and FDA continuously monitor the safety of vaccines.

These agencies use several different systems to monitor vaccine safety:

• The Vaccine Adverse Event Reporting System (VAERS): VAERS is an early warning system that helps CDC and FDA identify potential problems following vaccination. Anyone can and should report possible vaccine side effects to VAERS. However, most of the VAERS monitoring is done by U.S. healthcare providers providing anonymous data from hundreds of millions of patients being vaccinated. This system alerts the CDC and FDA if healthcare systems begin reporting unusual patterns of adverse effect information about events that occur after vaccinations.

NOTE: every healthcare provider who administers COVID-19 vaccines is required to report all serious health events occurring soon after vaccination to the VAERS system even if it seems clear that the death was not related to the vaccine. VAERS is therefore set up as an early warning system to collect as much data as possible about any and all events that may or may not turn out to be side effects of vaccines. Those data are then examined closely to verify the events and to identify any clusters or groups of unexpected serious or severe post-vaccine events. Because the data submitted to - and made publicly available by - VAERS has not yet been verified, the VAERS system clearly cannot determine whether a vaccine caused any specific side effect. VAERS is NOT - and is NOT INTENDED TO BE - a reliable source of information on vaccine side effects. Therefore, drawing conclusions from these publicly available but unverified VAERS screening data alone without the follow-up investigations is scientifically and ethically inappropriate because it is likely to lead to erroneous conclusions.

A description of how VAERS works is available.

• The Vaccine Safety Datalink (VSD): a collaboration between CDC and nine health care organizations around the United States, which allows ongoing monitoring and proactive searches of vaccine-related data.
• The Clinical Immunization Safety Assessment (CISA) Project: a partnership between CDC and several medical centers that conducts clinical research on vaccine-associated health risks.

Additional vaccine safety monitoring systems, such as the use of National Healthcare Safety Network (NHSN) data, and continued monitoring through clinical trials are also utilized to ensure the safety of COVID-19 vaccines.

NOTE – The current updated COVID-19 vaccines are called “bivalent” (meaning having two parts) because they are made from two different kinds of the SARS-CoV-2 virus that causes COVID-19.

Short term vaccine side effects fall into one of three categories:

(1) Local reactions, at or near the injection site

(2) Systemic reactions (such as fever, chills, headache, or muscle aches)

(3) Allergic reactions

This FAQ response addresses the local and systemic side effects that may occur in people of all ages. Allergic side effects are addressed in a later question (FAQ) and response. Although COVID-19 vaccination will help protect you from getting COVID-19 disease, you may have some short term local or systemic side effects from the vaccination, which are normal signs that your body is building protection against COVID-19.

Some vaccinated adults and children have had local reactions such as pain, redness, or tenderness at the injection site. A small number of vaccine recipients have had systemic side effects such as fatigue, nausea, chills, fever, headache or other body aches that may last for a few days. These local or systemic side effects do NOT mean that the vaccine has given you a COVID-19 infection. Rather, these expected side effects mean that the vaccine is causing your body’s immune system to react and create antibodies to fight off the virus that causes COVID-19 if you are exposed in the future.

Some vaccine recipients have experienced swollen glands (lymph nodes). For the two mRNA vaccines, these expected side effects are more common in younger people than older people and are more common after the second dose than after the first dose.

Less commonly, a few people have reported redness, swelling, and itching around the injection site beginning a few days or in the second week after their first vaccine dose. These local reactions are not considered to be allergic reactions and are not a risk for anaphylaxis when getting a second dose. Individuals with delayed injection site reactions after the first mRNA COVID-19 vaccine dose should get the second dose using the same vaccine product as the first dose and at the recommended interval, and preferably in the opposite arm. More information is available about these uncommon “COVID arm” reactions.

As with any vaccine, such as the flu vaccine, fainting soon after injection has also been noted among a small number of COVID-19 vaccine recipients, especially adolescents and young adults. This kind of short term reaction is not a reason to avoid future recommended doses of the COVID-19 vaccine.

Finally, even if you or your child experience one or more of these expected short term side effects after a dose of mRNA COVID-19 vaccine, it is very important that you still stay up to date by receiving all future recommended doses.

Some of the expected short term side effects could interfere with your - or your child’s - ability to do daily activities, but they should go away in a few days.

Age appropriate over-the-counter (OTC) medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen or naproxen, can help with the common side effects (for example, arm pain or fever) after those side effects start to occur. However, these drugs should not be taken before your COVID-19 vaccine doses since information on their possible impact on the body's immune response to COVID-19 infection is not yet available.

If you or your child have persistent injection site pain, fever, or other discomfort, talk to your healthcare provider about taking one of these OTC medicines.

To reduce pain and discomfort where you or your child got the shot:

• Apply a clean, cool, wet washcloth over the area.
• Use or exercise the arm as much as possible after receiving the shot to help prevent worsening pain and discomfort.
• Also, if possible, get some rest.
• Talk to your doctor about OTC medicines.

To reduce discomfort from fever:

• Dress in comfortable clothing.
• Drink plenty of fluids.
• Talk to your doctor about OTC medicines.

When to call the doctor:

In most cases, common side effects (like pain or discomfort at the injection site, fever, headache, fatigue, etc.) will not last more than a few days after a COVID-19 vaccine dose.

Contact your doctor or healthcare provider if:

• Redness or tenderness where you got the shot gets worse after 24 hours
• Side effects are worrying you or do not seem to be going away after a few days

Side effects or adverse events can be reported to CDC in VAERS.

Information on possible vaccine adverse events (side effects) continues to be collected and studied by CDC, FDA, and other groups, using multiple systems to collect the data.

To date, very few blood clotting problems in people who received an mRNA COVID-19 vaccination (Moderna or Pfizer-BioNTech) have been reported to VAERS. Based on currently available data, there is not an increased risk of this kind of problem after mRNA COVID-19 vaccination.

There have been rare reports of myocarditis or pericarditis among people ages 30 and younger who received a COVID-19 vaccine. Most patients responded well to rest and quickly recovered. More information on this topic can be found on CDC’s Myocarditis and Pericarditis After mRNA COVID-19 Vaccination webpage.

CDC and FDA continues to monitor reports of Guillain-Barré Syndrome (GBS), a rare disorder involving nerve damage that can occur in anyone receiving a vaccine. Most people fully recover from GBS, but some have permanent nerve damage. These cases have largely been reported about 2 weeks after vaccination and mostly in men, many 50 years and older. Recent CDC studies have found evidence suggesting an increased risk of GBS among adults 18 years and older after J&J/Janssen COVID-19 vaccination, but not after Pfizer-BioNTech or Moderna COVID-19 vaccination.

Given the ongoing risk of serious complications, hospitalization, and even death (including deaths of children) from COVID-19 illness, and given the rarity of serious adverse effects, CDC and VDH continue to strongly recommend being up to date with COVID-19 vaccinations, including with the most recently updated COVID-19 vaccine. Given the ongoing risk of serious complications, hospitalization, and even death (including deaths of children) from COVID-19 illness, and given the rarity of serious adverse effects, CDC and VDH continue to strongly recommend being  with COVID-19 vaccinations, including with the most recently updated COVID-19 vaccine.

An updated set of descriptions and recommendations for use of COVID-19 vaccines, including their side effects, can be found on the CDC website.

NOTE: As of May 6, 2023, the Janssen (Johnson & Johnson or J&J)  COVID-19 vaccine is no longer available in the United States. One serious but rare adverse effect that was identified with that vaccine was a blood clotting problem that occurred in a very small number of vaccinated people.

For additional information about rare, but serious side effects, visit the CDC page at Selected Adverse Events Reported after COVID-19 Vaccination.

No. Effects on reproduction have NOT been seen and are unlikely to occur after COVID-19 vaccination.

There is no genetic material in any of the current COVID-19 vaccines so there is no risk of a COVID-19 vaccine changing the DNA of any vaccine recipient or that person’s children.

Studies have been published about temporary post-vaccination changes in women’s menstrual cycles. However, short-term changes in menstrual cycles can be associated with stress, infection, weight changes, dietary changes (including a diet high in soy), excess exercise, or sleep problems. Studies do not suggest any impact on fertility and, not surprisingly, similar reports about changes in duration and flow of menstrual cycles have been noted after COVID-19 illness.

Additionally, people using hormonal birth control (pills, patch, ring, implant, etc.) can receive any of the current COVID-19 vaccines.

One recent study found no increase in the risk of miscarriages in the pregnancies of fully vaccinated women.

As noted elsewhere, there is no reason to withhold COVID 19 vaccine from women who are intending to get pregnant, are currently pregnant, are post-partum, and/or are breastfeeding. Getting a COVID-19 vaccine prior to or during pregnancy can protect you, your fetus, and your infant from severe COVID-19 illness.

In summary, no negative fertility effects have been found for any current U.S. COVID-19 vaccine and there is no biologic reason to suspect that COVID-19 vaccines might have an effect on female or male fertility.

More information is available at the following sources:

• A review of the safety of COVID-19 vaccines in terms of fertility and sexual function was published in the Scientific American magazine.
• A review of the vaccine-menstrual cycle study data
• A summary of the overall vaccine-menstrual cycle study data questions
• CDC’s COVID-19 Vaccines While Pregnant or Breastfeeding webpage

Providers are required by CDC to report vaccine administration information in a timely manner. Additionally, VDH requires all vaccine administrations, including COVID-19, to be reported to the Virginia Immunization Information System (VIIS). These reports are very important for ensuring that there is an established reporting and data feedback loop for the COVID-19 vaccine.

Yes. Healthcare providers who are interested in providing the COVID-19 vaccine may complete a Provider Intent form on the Virginia Electronic Registration for Immunization Programs (VERIP) website. VDH staff will contact providers once they have submitted their intent form to discuss the next steps to enroll as a COVID-19 vaccine provider.

Further information specific to enrollment as a vaccine provider in Virginia and general information from CDC are available.

CDC has self-study web modules for healthcare providers that can be found at Vaccine Courses, Broadcasts, Webcasts and Self Study Training and include a general overview of COVID-19 Immunization Best Practices (15 minutes) and a set of modules on what healthcare providers need to know about each of the current COVID-19 vaccines. Each of these courses includes continuing medical education (CME) credits.

Additional resources include the CDC website “Clinical Care Considerations for COVID-19 Vaccination,” the CDC “COVID-19 Vaccination” homepage for healthcare professionals, and COVID-19 Vaccine Product Information.The American College of Obstetricians and Gynecologists provides COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care.

The American Academy of Pediatrics provides COVID-19 Vaccine Resources and COVID-19 Frequently Asked Questions related to children.

U.S. healthcare providers or health departments can request a consultation from CDC’s Clinical Immunization Safety Assessment (CISA) COVIDvax project for any complex COVID-19 vaccine safety question that is (1) about an individual patient residing in the U.S. or vaccine safety issue and (2) not readily addressed by CDC or Advisory Committee on Immunization Practices (ACIP) guidelines.

This request can be made through CDC-INFO by:

• Calling 800-CDC-INFO (800-232-4636), or
• Submitting a request via CDC-INFO webform

For more information, visit the CDC’s Clinical Immunization Safety Assessment (CISA) Project webpage.

CDC provides information on how to address vaccine administration errors. Additional resources can be found on CDC’s vaccine administration web page.

Key points include:

• Inform the recipient of the vaccine administration error.
• Consult with the state immunization program and/or Immunization Information System (IIS) to determine how the dose should be entered into the IIS. The Virginia IIS homepage is available. 
• Report the error to the Vaccine Adverse Event Reporting System (VAERS). 
• Determine how the error occurred and implement strategies to prevent it from happening again. 

Adverse events that occur in a recipient following COVID-19 vaccination should be reported to VAERS. Vaccination providers are required by FDA and the provider agreement for the CDC COVID-19 Vaccination Program to report the following that occur after COVID-19 vaccination under BLA or EUA:

• Vaccine administration errors whether or not associated with an adverse event 
• Serious adverse events, irrespective of attribution to vaccination
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children 
• Cases of myocarditis 
• Cases of pericarditis 
• Cases of COVID-19 that result in hospitalization or death 

Reporting is encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-800-822-7967. 

No. Individuals can self-attest, or self-report, that they are eligible for an additional bivalent dose of an mRNA vaccine (with moderate or severe immunocompromising condition). Eligible persons should be able to receive this additional bivalent dose wherever vaccines are offered in Virginia.

Vaccine providers should ask patients questions to confirm eligibility for vaccination,  including the person’s age and previous COVID-19 vaccination history.

LTCFs are recommended to use their regular facility-pharmacy operations to acquire the COVID-19 vaccine for their residents and/or staff. LTCFs should maintain open and constant communication with their contracted pharmacy providers to discuss meeting COVID-19 vaccine needs moving forward. If your LTCF does not have a contracted pharmacy partner, see FAQs below for how to access vaccine.

The VDH Pharmacy Team is working to improve access to COVID-19 vaccines in LTC settings. Facilities that order and offer vaccination by other means should utilize their standard channels. Facilities that otherwise do not have access to COVID-19 vaccines and require assistance with obtaining vaccine may reach out to COVIDPharmacySupport@vdh.virginia.gov.

The Federal pharmacy partnership program will not be reinstated by CDC for COVID-19 vaccine assistance. However, CDC has partnered with various pharmacies to ensure LTCFs are able to access the COVID-19 vaccine. For more information, visit the CDC pharmacy partner contact information page. If you require further assistance in coordinating vaccines for your facility, please contact your local health district or email COVIDPharmacySupport@vdh.virginia.gov.

• Facilities are encouraged to enroll as a vaccine provider to be able to order and administer vaccines to staff and residents themselves. This will allow facilities to vaccinate residents and staff in a more timely manner. For more information, visit the VDH Provider Enrollment Process Flow & Checklist.
• If enrolling as a vaccine provider is not an option, you can consider identifying a local pharmacy to contract with.
• LTCFs may also submit an off-site clinic request with pharmacies who may be able to assist facilities with their vaccination needs. For more information, visit the CDC pharmacy partner contact information page.

If you require further assistance in coordinating COVID-19 vaccines for your facility, please contact your local health district or email COVIDPharmacySupport@vdh.virginia.gov.

LTCFs are able to order and administer vaccines through VaxMaX if the facility is enrolled as a vaccine provider. For more information on how to enroll as a vaccine provider, visit the VDH Provider Enrollment Process Flow & Checklist.

Patient education about the COVID-19 vaccine can be found on the VDH website. These resources can be used to help educate LTCF residents and staff who remain vaccine hesitant.

If the adverse event occurs while the pharmacy team is on site, then they will report the adverse event to VAERS. If it occurs after the pharmacy team has left, then the facility should report the event to VAERS. Both the pharmacy and the LTCF facility can report adverse events to VAERS; there is no double reporting jeopardy in the VAERS system. Information about how to report to VAERS can be found on their website. FAQs about VAERS reporting are also available. 

1. VAERS accepts reports from anyone. Patients, parents, caregivers and healthcare providers (HCP) are encouraged to report adverse events after vaccination to VAERS even if it is not clear that the vaccine caused the adverse event. 
2. Healthcare providers are required by law to report to VAERS: 
   1. Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination 
   2. An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine 
3. Healthcare providers are strongly encouraged to report: 
   1. Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event 
   2. Vaccine administration errors 
4. Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention. 

Additionally, the vaccine EUA fact sheet shared with vaccinated individuals contains information about post vaccination adverse event reporting.

There are multiple factors to be considered before deciding whether to conduct a vaccine clinic during an active COVID-19 outbreak.

1. Individuals with active COVID-19 infection are not recommended to receive a vaccination.  
2. If the outbreak is under control and is restricted to one unit/area of the facility, the clinic can be conducted by following the recommendations from CDC infection prevention guidance (under “indoor visitation during an outbreak response”). 
3. If the facility’s current outbreak response plan includes expanding routine COVID-19 testing, it is prudent to reschedule the vaccine clinic to a later date. 
4. The facility should notify the clinic provider about the outbreak situation to discuss next steps.

As of 10/26/2022, the Centers for Medicare and Medicaid Services (CMS) released an update regarding the COVID-19 vaccination definition and how LTC facilities should respond to infection control.

As outlined in §483.80(i) COVID-19 Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. The surveyors utilize a set of detailed guidelines outlined by CMS to complete the surveys. These guidelines have not changed and are used at each survey.