Ask the Experts: COVID-19: Vaccine Safety

Results (13)

Recipients of mRNA COVID-19 vaccines often experience local (e.g., pain, swelling, redness at the injection site, localized swollen lymph nodes in the armpit of the vaccinated arm) or systemic (e.g., fever, fatigue, headache, chills, body and joint aches) post-vaccination symptoms. Depending on vaccine product (Pfizer-BioNTech vs. Moderna), age group, and vaccine dose, in clinical trials, approximately 80–91% of vaccinated people developed at least one local symptom and 55–91% developed at least one systemic symptom following vaccination.

Most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1–3 days of onset.

Among children ages 6 months through 4 years (Pfizer-BioNTech) or 6 months through 5 years (Moderna), pain or tenderness at the injection site was the most frequent local reaction noted in clinical trials. The most common systemic symptom in older children was fatigue; in younger children (ages 6 through 23 months), irritability/crying and drowsiness/sleepiness were most common. Most systemic symptoms were mild to moderate in severity, typically began 1 to 2 days after vaccination, and resolved after 1 to 2 days.

Last reviewed: November 16, 2024

In clinical trials of Novavax COVID-19 Vaccine, pain or tenderness at the injection site was the most frequently reported local reaction among vaccine recipients; redness and swelling were reported less frequently. Fatigue, headache, and muscle pain were the most commonly reported systemic reactions. Most symptoms were mild to moderate in severity and resolved within 1 to 3 days. Overall, symptoms were more frequent in people ages 18 through 64 years compared to people ages 65 years and older and more frequent after dose 2 than dose 1.

Last reviewed: November 16, 2024

Vaccine safety monitoring in the United States indicated an increased risk of GBS within 42 days of vaccination with the Janssen COVID-19 Vaccine, with the highest risk among people ages 40 through 64. Most reports were in males. Janssen COVID-19 Vaccine is no longer available in the United States.

Any FDA-authorized or FDA-licensed COVID-19 vaccine may be given to individuals with a history of GBS.

Last reviewed: November 16, 2024

There is no evidence that any of the COVID-19 vaccines affect current or future fertility.

Last reviewed: November 16, 2024


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Last reviewed: May 26, 2023

There is a rare risk of myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the tissue surrounding the heart) following receipt of any COVID-19 vaccine. This rare risk is greatest in biological males age 12 through 39 years. Despite this risk, evaluation demonstrates that the benefits of vaccination clearly outweigh the risks in all age groups.

This risk appears related to age, biological sex, and the short (3- to 4-week) interval between primary series doses, where applicable. For individuals who are recommended to receive a primary series of more than one dose, extending the interval between doses to 8 weeks may reduce the rare risk of myocarditis following the second dose.

Most patients diagnosed with myocarditis after mRNA COVID-19 vaccination have been hospitalized for short periods, with most completely recovering from their acute symptoms. Post-vaccination myocarditis is milder than myocarditis following viral infection. CDC continues to assess long-term outcomes in people with myocarditis after mRNA COVID-19 vaccination.

People receiving COVID-19 vaccines, especially males age 12 through 39, should be counseled about the risk of myocarditis or pericarditis and advised to seek medical attention promptly if they develop chest pain, shortness of breath, or feelings of a fast, fluttering, or pounding heartbeat.

Cases of myocarditis and pericarditis were identified in clinical trials of Novavax COVID-19 Vaccine and have also been reported during post-authorization use outside the United States. These findings suggest that an increased risk for these conditions may be present after receiving Novavax COVID-19 vaccine.

Current recommendations are for a single dose of any FDA-licensed or FDA-authorized 2024–2025 Formula COVID-19 vaccine for most people age 5 years and older, even if the individual is previously unvaccinated. Previously unvaccinated individuals who receive Novavax vaccine are recommended to receive two doses, given 3 to 8 weeks apart.

CDC’s complete interim clinical considerations for COVID-19 vaccination and myocarditis or pericarditis are available here: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis.

CDC also has published additional clinical considerations for the evaluation and care of patients with myocarditis or pericarditis following mRNA vaccination: www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html.

Last reviewed: November 16, 2024

Serious allergic reactions, such as anaphylaxis, in the minutes following vaccination are rare but are possible with any vaccine. Every vaccination site should have staff available who are trained and equipped to recognize and respond to signs of anaphylaxis in a vaccine recipient. See this CDC website for additional information about preparing for the management of anaphylaxis following COVID-19 vaccination: www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html?anaphylaxis-management.html.

Anaphylaxis following vaccination with mRNA COVID-19 vaccines is reported at a rate of approximately 5 cases per million doses administered.

An immediate severe allergic reaction to any component or previous dose of any mRNA COVID-19 vaccine is a contraindication to vaccination with both the Pfizer-BioNTech and Moderna vaccines (all formulations); however, such a reaction is generally a precaution to the use of the Novavax vaccine; see the CDC’s COVID-19 interim clinical considerations section on contraindications and precautions for details: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#contraindications.

CDC also provides specific COVID-19 vaccination guidance for people with a history of allergies or allergic reactions: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#history-allergies-reactions.

Last reviewed: November 16, 2024

In accordance with general best practices for vaccination, all people should be observed for at least 15 minutes after vaccination for signs of an immediate allergic reaction.

If you vaccinate a person who has a precaution to COVID-19 vaccination, you should consider a 30-minute observation period following vaccination. See CDC’s detailed considerations for people with a history of allergies or allergic reactions: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#history-allergies-reactions.

Last reviewed: November 16, 2024

CDC maintains a website for information for the public about COVID-19 vaccine safety: www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. 

For information about how to evaluate and manage people with a history of allergy who present for COVID-19 vaccination, see CDC’s additional considerations for people with a history of allergies or allergic reactions: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#history-allergies-reactions.

Last reviewed: November 16, 2024

The following guidance is taken directly from the CDC: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#adverse-events.

For licensed COVID-19 vaccines (Moderna and Pfizer-BioNTech in people ages 12 years and older), healthcare providers are strongly encouraged to report to VAERS:

  • 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
  • Vaccine administration errors, whether or not associated with an adverse event

For COVID-19 vaccines given under an EUA, vaccination providers are required to report to VAERS:

  • Vaccine administration errors, whether or not associated with an adverse event
  • Serious adverse events regardless of causality. Serious adverse events per FDA are defined as:
    • Death
    • A life-threatening adverse event
    • Inpatient hospitalization or prolongation of existing hospitalization
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • A 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) in children and adults
  • Cases of myocarditis
  • Cases of pericarditis
  • Cases of COVID-19 that result in hospitalization or death

Reporting is also 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.

Last reviewed: November 16, 2024

Multiple national surveillance systems are used to monitor the safety of COVID-19 vaccines in different ways. CDC provides information about vaccine safety surveillance systems, with links to information about the safety of each licensed and recommended vaccine, including COVID-19 vaccines, here: www.cdc.gov/vaccine-safety/index.html.

Last reviewed: November 16, 2024

V-safe is a safety monitoring system that vaccine recipients can use to share with CDC how they feel after vaccination. It was created initially for COVID-19 vaccines. Currently, recipients of protein-based RSV vaccines (Arexvy, GSK; Abrysvo, Pfizer) also may register for V-safe. To learn more about the program and how to guide vaccine recipients who wish to participate, visit CDC’s website: www.cdc.gov/vaccine-safety-systems/v-safe/index.html.

Last reviewed: November 16, 2024

No. The COVID-19 vaccines are not currently part of the VICP, although a transition to the VICP is anticipated in the future. The COVID-19 vaccines are currently part of a similar program called the Countermeasures Injury Compensation Program (CICP). For more information, visit this web page: www.hrsa.gov/cicp.

Last reviewed: November 16, 2024

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