Patient counseling (Pre-vaccination counseling )


Pre-vaccination counseling

The vaccine-specific Fact Sheet for Recipients and Caregivers (Pfizer-BioNTech, Moderna, Janssen) should be provided to all vaccine recipients, parents or guardians, and caregivers (when relevant) before vaccination with any currently FDA-approved or FDA-authorized COVID-19 vaccine. They should be informed that mRNA vaccines are preferred over the Janssen COVID-19 Vaccine and that there is a risk of thrombosis with thrombocytopenia syndrome (TTS) following receipt of the Janssen COVID-19 Vaccine. Those who elect to receive the Janssen COVID-19 Vaccine should be informed about the risk and symptoms of TTS that can occur (typically in the 2 weeks after vaccination), as well as the need to seek immediate medical care should symptoms develop.


Potential for local and systemic reactions

Before vaccination, providers should counsel COVID-19 vaccine recipients, parents, or guardians about expected local (e.g., pain, swelling, erythema at the injection site) and systemic (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) post-vaccination reactions. Localized axillary lymphadenopathy4 on the same side as the vaccinated arm has been observed following vaccination with mRNA COVID-19 vaccines.


Anaphylactic reactions have been rarely reported following receipt of COVID-19 vaccines. Administration of antihistamines to COVID-19 vaccine recipients before vaccination to prevent allergic reactions is not generally recommended. However, while antihistamines will not prevent anaphylaxis, some experts advise antihistamine use as a means of preventing milder allergic reactions in patients who might be at higher risk for allergic reactions.


Management of post-COVID-19-vaccination symptoms

For all currently FDA-approved or FDA-authorized COVID-19 vaccines, antipyretic or analgesic medications can be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate; these medications should not be used prophylactically for the purposes of prevention of post-vaccination symptoms. However, in general, aspirin is not recommended for use in children and adolescents ages 17 years and younger as an antipyretic or analgesic due to the risk of Reye’s syndrome.


Additional guidance is available for assessing and responding to post-vaccination signs and symptoms in workplaces, including healthcare settings, and among long-term care facility residents.


Special populations

People with autoimmune conditions

People with autoimmune conditions may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine but, as with the general population, mRNA vaccines are preferred over the Janssen COVID-19 Vaccine. If people with these conditions are immunocompromised because of medications such as high-dose corticosteroids or biologic agents, they should consult Guidance for COVID-19 vaccination for people who are moderately or severely immunocompromised.


People with a history of Bell’s palsy

Rare cases of Bell’s palsy (acute peripheral facial nerve palsy) were reported following vaccination of participants in the mRNA COVID-19 vaccine clinical trials, but FDA was not able to determine whether these cases were causally related to vaccination. People with a history of Bell’s palsy may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine.


People with a history of dermal filler use

Infrequently, people who have received dermal fillers might experience swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. The swelling is temporary and resolves with medical treatment, including corticosteroid therapy. People should be advised to contact their healthcare professional for evaluation if they experience swelling at or near a dermal filler site following vaccination.


People receiving antiviral therapy

Administration of an antiviral drug at any interval before or after vaccination with any of the currently FDA-approved or FDA-authorized COVID-19 vaccines is unlikely to impair development of a protective antibody response.


People undergoing testing for tuberculosis infection

COVID-19 vaccination should not be delayed because of testing for tuberculosis (TB) infection. Testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon-gamma release assay (IGRA), can be done before, after, or during the same encounter as COVID-19 vaccination.


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