Anaphylaxisan acute and potentially life-threatening allergic reaction, has been reported rarely following COVID-19 vaccination. These interim considerations provide recommendations on assessment and potential management of anaphylaxis following COVID-19 vaccination. Detailed information on CDC recommendations for vaccination, including contraindications and precautions to vaccination, can be found in the Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States. Patients should be screened prior to receipt of each vaccine dose, and those with a contraindication should not be vaccinated. Resources from Immunize.org are available to help providers determine if a contraindication or precaution exists for all routinely recommended vaccines for adults and children and teens, including COVID-19 vaccines.
Healthcare personnel who are trained and qualified to recognize the signs and symptoms of anaphylaxis, as well as administer intramuscular epinephrine, should be available at the vaccination location at all times. Vaccination locations that anticipate vaccinating people with COVID-19 vaccines, including mass vaccination clinics, should plan adequate staffing and supplies (including epinephrine) for the assessment and potential management of anaphylaxis.
*COVID-19 vaccination locations should have at least 3 doses of age-appropriate epinephrine available at all times, and the ability to quickly obtain additional doses to replace supplies after epinephrine is administered to a patient. Locations that are administering COVID-19 vaccines to children
Additionally, to monitor for allergic reactions, providers should consider observing people with the following precautions to a previously administered COVID-19 vaccine type for 30 minutes if a subsequent dose of the same vaccine type is administered:
Anaphylaxis should be considered when signs or symptoms are generalized (i.e., if there are generalized hives or more than one body system is involved) or are serious or life-threatening in nature, even if they involve a single body system (e.g., hypotension, respiratory distress, or significant swelling of the tongue or lips).
Symptoms of anaphylaxis often occur within 15-30 minutes of vaccination, though it can sometimes take several hours for symptoms to appear. Early signs of anaphylaxis can resemble a mild allergic reaction, and it is often difficult to predict whether initial, mild symptoms will progress to become an anaphylactic reaction. In addition, symptoms of anaphylaxis might be more difficult to recognize in infants and toddlers, people with communication difficulties, such as long-term care facility residents with cognitive impairment, those with neurologic disease, or those taking medications that can cause sedation. Not all symptoms listed above are necessarily present during anaphylaxis, and not all patients have skin reactions.
If anaphylaxis is suspected, administer epinephrine as soon as possible, contact emergency medical services, and transfer patients to a higher level of medical care. In addition, instruct patients to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location.
There are no contraindications to the administration of epinephrine for the treatment of anaphylaxis. Although adverse cardiac events, such as myocardial infarction or acute coronary syndrome, have been reported in some patients who received epinephrine for treatment of anaphylaxis (particularly among older adults with hypertension and/or atherosclerotic heart disease), epinephrine is the first-line treatment for anaphylaxis. It is important that locations providing vaccination to older adults, including long-term care facility residents, have staff members available who are able to recognize the signs and symptoms of anaphylaxis. This will help not only to ensure appropriate and prompt treatment for patients with anaphylaxis, but also to avoid unnecessary epinephrine administration to patients who do not have anaphylaxis.
Pregnant people with anaphylaxis should be managed in the same manner as non-pregnant people. As with all patients with anaphylaxis, they should be transported to a medical facility where they and their fetus can be closely monitored to ensure adequate perfusion.
People with a contraindication to one COVID-19 vaccine type (Table 3) may receive the alternative COVID-19 vaccine type* in the usual vaccination setting. Consultation with an allergist-immunologist is encouraged to provide expert evaluation of the original allergic reaction, and depending on the outcome of the evaluation, reassess if administration of additional doses of the same vaccine type may be possible.
People with an allergy-related precaution to one COVID-19 vaccine type (Table 3) may receive the alternative COVID-19 vaccine type* in the usual vaccination setting. Vaccination with the same COVID-19 vaccine type may be considered on an individual basis; the same vaccine type should be administered in an appropriate setting and under the supervision of a health care provider experienced in the management of severe allergic reactions. An observation period of 30 minutes post-vaccination should be considered. Referral to an allergist-immunologist should be considered.
Anyone can report any adverse events, including anaphylaxis, that occur in a recipient following COVID-19 vaccination, to the Vaccine Adverse Event Reporting System (VAERS). Reporting is encouraged for any clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. For detailed reporting requirements for VAERS, please see Clinical Guidance for COVID-19 Vaccination CDC. Refer to the VAERS website or call
1-800-822-7967 for more information on how to submit a report to VAERS.
In patients who experience post-vaccination symptoms, determining the etiology (including allergic reaction, vasovagal reaction, or vaccine side effects) is important to determine whether a person can receive further doses of the vaccine. The following table of signs and symptoms is meant to serve as a resource but might not be exhaustive, and patients might not have all signs or symptoms. Vaccination providers should use their clinical judgement when assessing patients to determine the diagnosis and management.
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