Key points
- Coronavirus disease 2019, or (COVID-19), is a respiratory disease caused by the SARS-CoV-2 virus.
- COVID-19 vaccines can help reduce the risk of illness from COVID-19 and its potentially serious complications.
Overview
COVID-19 spreads mainly from person-to-person through respiratory droplets produced when an infected person coughs, sneezes, or talks. Some people who are infected may not have symptoms. For people who have symptoms, illness can range from mild to severe.
Fact
Available vaccines & manufacturer package inserts
Pfizer-BioNTech (Comirnaty®) and Moderna (Spikevax®)
- Approved for use or authorized for emergency use by the FDA in the United States.
- mRNA vaccines that use mRNA created in a laboratory to teach cells how to make a protein that triggers an immune response inside the body.
- Authorized for children ages 6 months through 11 years and approved for people ages 12 years and older.
Novavax
- A protein subunit vaccine that contains spike proteins of the virus that causes COVID-19. After learning how to respond to the spike protein, the immune system will respond quickly to protect against the actual COVID-19 virus.
- Authorized for people 12 years and older.
Fact
Manufacturer package inserts and factsheets
Fully licensed FDA vaccines
- FDA approved Comirnaty in 2021. It is approved for use in people 12 years of age and older. This is a single dose injection.
- FDA approved Spikevax in 2022. It is approved for use in people 12 years of age and older.
Emergency use authorization vaccines
- FDA authorized Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 6 months to 11 years.
- FDA authorized Moderna COVID-19 vaccine for emergency use in children ages 6 months to 11 years.
- FDA authorized Novavax COVID-19 vaccine for emergency use in people ages 12 years and older.
Who should & should not get the vaccine
CDC recommends that people receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination.
Learn information about COVID-19 vaccination, recommendations, provider requirements and support, or who should and should not get vaccinated.
Common side effects
The most common side effects are usually mild, such as soreness in the area where the shot was given. Vaccines, like any medicine, can have side effects. Side effects after getting a COVID-19 vaccine vary from person to person.
mRNA vaccines (Pfizer-BioNTech and Moderna)
- Pain, soreness, redness at injection site.
- Fatigue.
- Headache.
- Muscle pain.
- Joint pain.
- Chills.
- Fever.
- Nausea/vomiting (Moderna).
- In infants and toddlers, common symptoms include irritability or crying, decreased appetite, and sleepiness.
Protein subunit vaccine (Novavax)
- Pain, soreness, redness, swelling at injection site.
- Fatigue.
- Headache.
- Muscle pain.
- Joint pain.
- Chills.
- Fever.
- Nausea/vomiting.
Keep in mind
Everyone who gets a COVID-19 vaccine may be monitored onsite for at least 15 minutes after vaccination (people who experience or have experienced non-severe allergic reactions to COVID vaccines may be monitored for 30 minutes).
Severe allergic reactions
Severe allergic reactions following vaccination are rare but can be life threatening. Symptoms of a severe allergic reaction may include:
- Anaphylaxis, which is a life-threatening reaction that needs to be treated with epinephrine (EpiPen) and may require hospitalization. Symptoms include wheezing, difficulty breathing, or low blood pressure; and sometimes hives.
- Swelling of the airway, which includes the tongue, uvula, or larynx.
- A widespread rash involving the skin and inside places like your mouth or nose that required hospitalization.
When to seek emergency care
If you had a severe allergic reaction after receiving a particular type of COVID-19 vaccine (either mRNA or Novavax), you should not get another dose of that type of vaccine. You will likely be able to receive the alternate vaccine type. Your doctor may refer you to an allergy and immunology specialist for additional care or advice.
In rare cases, people have experienced serious health events after COVID-19 vaccination. An adverse event (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) can be caused by the vaccine or be a coincidental event that is not related to the vaccine, such as an unrelated fever, that happened following vaccination.
Report possible adverse events to VAERS
A closer look at the safety data
Fact
COVID-19 vaccines meet the FDA's standards for safety and effectiveness.12345678910111213
Anaphylaxis, myocarditis, and pericarditis
To date, the systems in place to monitor the safety of these vaccines have found two serious types of adverse events following COVID-19 vaccination. The two serious adverse events following COVID-19 vaccination currently used in the United States are anaphylaxis and myocarditis or pericarditis.
- Anaphylaxis is a severe type of allergic reaction that can rarely happen after any vaccine. Anaphylaxis needs to be treated with epinephrine (for example, EpiPen) and may require hospitalization. Anaphylaxis can involve wheezing, difficulty breathing, or low blood pressure; and sometimes is accompanied by hives. Anaphylaxis after COVID-19 vaccination is rare.145711141516
- It has occurred at a rate of approximately 5 cases per one million vaccine doses administered. Anaphylaxis, a severe type of allergic reaction, can occur after any kind of vaccination. If it happens, healthcare providers can effectively and immediately treat the reaction.
- It has occurred at a rate of approximately 5 cases per one million vaccine doses administered. Anaphylaxis, a severe type of allergic reaction, can occur after any kind of vaccination. If it happens, healthcare providers can effectively and immediately treat the reaction.
- Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. Myocarditis and pericarditis after COVID-19 vaccination are rare.1234567911121718192021 Most patients with myocarditis or pericarditis after COVID-19 vaccination responded well to medicine and rest and felt better quickly.
- Pericarditis is inflammation of the outer lining of the heart. Most patients with pericarditis after COVID-19 vaccination responded well to medicine and rest and felt better quickly, and most cases have been reported after receiving mRNA COVID-19 vaccines.
The evidence suggests that, although rare, these events are linked to certain types of COVID-19 vaccinations that were administered. Healthcare providers should review additional recommendations and clinical guidance on myocarditis considerations.
Investigating long-term effects of myocarditis
- CDC is contacting people (or their parents or guardians) who meet the case definition for myocarditis (i.e., have symptoms of myocarditis and medical tests to support its diagnosis and rule out other causes) following COVID-19 vaccination in VAERS.
- CDC may contact your healthcare provider for information on medications you take and your test results.
- Personal information and responses will be kept private to the extent allowable under the law. If the patient is a minor, a parent or legal guardian will be invited to participate on their behalf.
- The person's name and any identifying information will not be included in any reports.
- The person's name and any identifying information will not be included in any reports.
- Initial patient surveys showed nearly all patients (80%) were considered by their cardiologist or other healthcare provider to have either fully or probably fully recovered.22
Guillain-Barré Syndrome (GBS)
Based on an analysis of data from the Vaccine Safety Datalink (VSD), the rate of GBS within the first 21 days following J&J/Janssen COVID-19 vaccination was found to be 21 times higher than after Pfizer-BioNTech or Moderna (mRNA) COVID-19 vaccination. After the first 42 days, the rate of GBS was 11 times higher following J&J/Janssen COVID-19 vaccination. The analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna vaccination.
Similarly, CDC found higher than expected rates of GBS reported to VAERS after J&J/Janssen COVID-19 vaccination but not after mRNA COVID-19 vaccination. These observations contributed to the preferential recommendation by the Advisory Committee on Immunization Practices (ACIP) to use mRNA COVID-19 vaccines over the J&J/Janssen COVID-19 vaccine, which is no longer available in the United States.
Thrombosis with Thrombocytopenia Syndrome (TTS)
Thrombosis with thrombocytopenia syndrome (TTS) has been rarely observed after J&J/Janssen COVID-19 vaccination and has occurred in approximately 4 cases per one million doses administered. TTS is a rare but serious adverse event that causes blood clots in large blood vessels and low platelets (blood cells that help form clots).
A review of reports indicates a causal relationship between the J&J/Janssen COVID-19 vaccine and TTS. This observation contributed to the preferential recommendation by ACIP to use mRNA COVID-19 vaccines over the J&J/Janssen COVID-19 vaccine, which is no longer available in the United States.23242526
Reports of deaths
Multiple factors contribute to reports of death after COVID-19 vaccination, including heightened public awareness of COVID-19 vaccines, requirements under FDA authorization for COVID-19 vaccines that healthcare providers report any death after COVID-19 vaccination to VAERS (even if it is unclear whether the vaccine was the cause), and reporting requirements in CDC vaccine provider agreements. People receiving COVID-19 vaccines are less likely to die from COVID-19 and its complications and are at no greater risk of death from non-COVID causes, than unvaccinated people.27282930
How CDC monitors vaccine safety
CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.
Resources
- Hause AM, Marquez P, Zhang B, et al. COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18, 2022–August 21, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1115–1120. DOI: http://dx.doi.org/10.15585/mmwr.mm7135a3
- Fleming-Dutra KE, Wallace M, Moulia DL, et al. Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022. MMWR Morb Mortal Wkly Rep 2022;71:859–868. DOI: http://dx.doi.org/10.15585/mmwr.mm7126e2
- Hause AM, Baggs J, Marquez P, et al. COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1755–1760. DOI: http://dx.doi.org/10.15585/mmwr.mm705152a1
- Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., Munjal, I., Perez, J. L., ... C4591007 Clinical Trial Group (2022). Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. The New England journal of medicine, 386(1), 35–46. https://doi.org/10.1056/NEJMoa2116298
- https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/05-COVID-Su-508.pdf
- Woodworth KR, Moulia D, Collins JP, et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021. MMWR Morb Mortal Wkly Rep 2021;70:1579–1583. DOI: http://dx.doi.org/10.15585/mmwr.mm7045e1
- Hause AM, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years — United States, December 9, 2021–February 20, 2022. MMWR Morb Mortal Wkly Rep 2022;71:347–351. DOI: http://dx.doi.org/10.15585/mmwr.mm7109e2
- Shimabukuro, T. T., Nguyen, M., Martin, D., & DeStefano, F. (2015). Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine, 33(36), 4398–4405. https://doi.org/10.1016/j.vaccine.2015.07.035
- Oster, M. E., Shay, D. K., Su, J. R., Gee, J., Creech, C. B., Broder, K. R., Edwards, K., Soslow, J. H., Dendy, J. M., Schlaudecker, E., Lang, S. M., Barnett, E. D., Ruberg, F. L., Smith, M. J., Campbell, M. J., Lopes, R. D., Sperling, L. S., Baumblatt, J. A., Thompson, D. L., Marquez, P. L., ... Shimabukuro, T. T. (2022). Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA, 327(4), 331–340. https://doi.org/10.1001/jama.2021.24110
- Hause AM, Gee J, Baggs J, et al. COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1053-1058. DOI: http://dx.doi.org/10.15585/mmwr.mm7031e1
- Dooling K, Gargano JW, Moulia D, et al. Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, September 2021. MMWR Morb Mortal Wkly Rep 2021;70:1344–1348. DOI: http://dx.doi.org/10.15585/mmwr.mm7038e2
- Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal Wkly Rep 2021;70:977–982. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2
- Wallace M, Woodworth KR, Gargano JW, et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 Years — United States, May 2021. MMWR Morb Mortal Wkly Rep 2021;70:749–752. DOI: http://dx.doi.org/10.15585/mmwr.mm7020e1
- Shimabukuro, T., & Nair, N. (2021). Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine. JAMA, 325(8), 780–781. https://doi.org/10.1001/jama.2021.0600
- Shimabukuro TT, Cole M, Su JR. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021. JAMA. 2021;325(11):1101–1102. doi:10.1001/jama.2021.1967
- Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep 2021;70:125–129. DOI: http://dx.doi.org/10.15585/mmwr.mm7004e1
- Kristin Goddard, Kayla E. Hanson, Ned Lewis, et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States. Ann Intern Med.2022;175:1169-1771. [Epub 4 October 2022]. doi:10.7326/M22-2274
- Kracalik, I., Oster, M. E., Broder, K. R., Cortese, M. M., Glover, M., Shields, K., Creech, C. B., Romanson, B., Novosad, S., Soslow, J., Walter, E. B., Marquez, P., Dendy, J. M., Woo, J., Valderrama, A. L., Ramirez-Cardenas, A., Assefa, A., Campbell, M. J., Su, J. R., Magill, S. S., ... Myocarditis Outcomes After mRNA COVID-19 Vaccination Investigators and the CDC COVID-19 Response Team (2022). Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. The Lancet. Child & adolescent health, 6(11), 788–798. https://doi.org/10.1016/S2352-4642(22)00244-9
- Goddard, K., Lewis, N., Fireman, B., Weintraub, E., Shimabukuro, T., Zerbo, O., Boyce, T. G., Oster, M. E., Hanson, K. E., Donahue, J. G., Ross, P., Naleway, A., Nelson, J. C., Lewin, B., Glanz, J. M., Williams, J. T. B., Kharbanda, E. O., Katherine Yih, W., & Klein, N. P. (2022). Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination. Vaccine, 40(35), 5153–5159. https://doi.org/10.1016/j.vaccine.2022.07.007
- Weintraub ES, Oster ME, Klein NP. Myocarditis or Pericarditis Following mRNA COVID-19 Vaccination. JAMA Netw Open. 2022;5(6):e2218512. doi:10.1001/jamanetworkopen.2022.18512
- Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022;327(4):331–340. doi:10.1001/jama.2021.24110
- Kracalik, I., Oster, M. E., Broder, K. R., Cortese, M. M., Glover, M., Shields, K., Creech, C. B., Romanson, B., Novosad, S., Soslow, J., Walter, E. B., Marquez, P., Dendy, J. M., Woo, J., Valderrama, A. L., Ramirez-Cardenas, A., Assefa, A., Campbell, M. J., Su, J. R., Magill, S. S., ... Myocarditis Outcomes After mRNA COVID-19 Vaccination Investigators and the CDC COVID-19 Response Team (2022). Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. The Lancet. Child & adolescent health, 6(11), 788–798. https://doi.org/10.1016/S2352-4642(22)00244-9
- See I, Su JR, Lale A, et al. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA. 2021;325(24):2448–2456. doi:10.1001/jama.2021.7517
- Isaac See, Allison Lale, Paige Marquez, et al. Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination—United States, December 2020 to August 2021. Ann Intern Med.2022;175:513-522. [Epub 18 January 2022]. doi:10.7326/M21-4502
- https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
- Oliver, S. E., Wallace, M., See, I., Mbaeyi, S., Godfrey, M., Hadler, S. C., Jatlaoui, T. C., Twentyman, E., Hughes, M. M., Rao, A. K., Fiore, A., Su, J. R., Broder, K. R., Shimabukuro, T., Lale, A., Shay, D. K., Markowitz, L. E., Wharton, M., Bell, B. P., Brooks, O., ... Daley, M. F. (2022). Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR. Morbidity and mortality weekly report, 71(3), 90–95. https://doi.org/10.15585/mmwr.mm7103a4
- Xu, S., Huang, R., Sy, L. S., Hong, V., Glenn, S. C., Ryan, D. S., Morrissette, K., Vazquez-Benitez, G., Glanz, J. M., Klein, N. P., Fireman, B., McClure, D., Liles, E. G., Weintraub, E. S., Tseng, H. F., & Qian, L. (2023). A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination. Vaccine, 41(3), 844–854. https://doi.org/10.1016/j.vaccine.2022.12.036
- Xu S, Huang R, Sy LS, et al. COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1520–1524. DOI: http://dx.doi.org/10.15585/mmwr.mm7043e2
- Day, B., Menschik, D., Thompson, D., Jankosky, C., Su, J., Moro, P., Zinderman, C., Welsh, K., Dimova, R. B., & Nair, N. (2023). Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021. Pharmacoepidemiology and drug safety, 32(7), 763–772. https://doi.org/10.1002/pds.5605
- Rosenblum, H. G., Gee, J., Liu, R., Marquez, P. L., Zhang, B., Strid, P., Abara, W. E., McNeil, M. M., Myers, T. R., Hause, A. M., Su, J. R., Markowitz, L. E., Shimabukuro, T. T., & Shay, D. K. (2022). Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. The Lancet. Infectious diseases, 22(6), 802–812. https://doi.org/10.1016/S1473-3099(22)00054-8
- Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, Nair N, Martin S, Clark T, Markowitz L, Lindsey N, Zhang B, Licata C, Jazwa A, Sotir M, Shimabukuro T. First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020-January 13, 2021MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70;283-288.
- Chapin-Bardales J, Gee J, Myers T. Reactogenicity Following Receipt of mRNA-Based COVID-19 VaccinesJAMA Insights 2021 April 5. doi:10.1001/jama.2021.5374 Epub ahead of print.
- Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu T, Chang KT, Ellington SR, Burke VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant PersonsN Engl J Med 2021 April 21. DOI: 10.1056/NEJMoa2104983 Epub ahead of print.
- Gubernot D, Jazwa A, Niu M, Baumblatt J, Gee J, Moro P, Duffy J, Harrington T, McNeil MM, Broder K, Su J, Kamidani S, Olson CK, Panagiotakopoulos L, Shimabukuro T, Forshee R, Anderson S, Bennet S. U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccinesVaccine 2021 Jun 23;39(28):3666-3677. Epub 2021 May 14.
- Pingali C, Meghani M, Razzaghi H, , Lamias MJ, Weintraub E, Kenigsberg TA, Klein NP, Lewis N, Fireman B, Zerbo O, Bartlett J, Goddard K, Donahue J, Hanson K, Naleway A, Kharbanda EO, Yih K, Clark Nelson J, Lewin BJ, Williams JTB, Glanz JM, Singletom JA, Patel SA. COVID-19 Vaccination Coverage Among Insured Persons Aged ≥ 16 years, by Race/Ethnicity and Other Selected Characteristics — Eight Integrated Health Care Organizations, United States, December 14, 2020-May 15, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):985-990.
- Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot K, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021MMWR Morb Mortal Wkly Rep. 2021 Aug 10.
- Klein NP, Lewis N, Goddard K, Fireman B, Zerbo Q, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Clark Nelson J, Xu S, Yih WK, Glanz JM, Williams JTB, Hambridge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for Adverse Events After COVID-19 mRNA VaccinationJAMA 2021 Sept 3. Doi:10.1001/jama.2021.15072.
- Hause AM, Baggs J, Gee J, Marquez P, Myers TR, Shimabukuro TT, Shay DK. Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12-September 19, 2021MMWR Morb Mortal Wkly Rep. epub 2021 Sep 28.
- Chapin-Bardales J, Myers T, Gee J, Shay DK, Marquez P, Baggs J, Zhang B, Licata C, Shimabukuro TT. Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: Findings from the CDC v-safe surveillance system.Vaccine 2021 Nov 26;39(48):7066-7073. Epub 2021 Oct 16.
- Abara WE, Gee J, Mu Y, Deloray M, Ye T, Shay DK, Shimabukuro T. Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring J Infect Dis. 2021 Dec 27;jiab628. Online ahead of print.
- Lipkind HS, Vazquez-Benitez G, DeSilva M, Vesco KK, Ackerman-Banks C, Zhu J, Boyce TG, Daley MF, Fuller CC, Getahun D, Irving SA, Jackson LA, Williams JTB, Zerbo O, McNeil MM, Olson CK, Weintraub E, Kharbanda KO. Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth — Eight Integrated Health Care Orgnizations, United States, December 15, 2020-July 22, 2021.MMWR Morb Mort Wkly Rep. 2022 Jan 4:71 Early release.
- Moro PL, McNeil MM. Successes of the CDC monitoring systems in evaluating post-authorization safety of COVID-19 vaccines [Editorial]. Expert Rev Vaccines. 2022 Mar;21(3):284-284. Epub 2022 Jan 5.
- Hause AM, Bags J, Myers TR, Su JR, Blanc PG, Girwa Baumblatt JA, Woo EJ, Gee J, Shimabukuro TT, Shay DK. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021-February 6, 2022MMWR Morb Mortal Wkly Rep 2022 Feb 11;71. Early Release.
- Rosenblum HG, Gee JM, Liu R, Marquez PL, Zhang B, Strid P, Abara WE, McNeil MM, Myers TR, Hause AM, Su JR, Baer B, Menschik D, Markowitz LE, Shimabukuro TT, Shay DK. Safety monitoring of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to Vaccine Adverse Events Reporting System and v-safeLancet Infect Dis.2022 Mar 7;S1473-3099(22)0054-8. Online ahead of print.
- Kenigsberg TA, Hause AM, McNeil MM, Nelson JC, Shoup JA, Goddard K, Lou Y, Hanson KE, Glenn SC, Weintraub E. Dashboard development for near real-time visualization of COVID-19 vaccine safety surveillance data in the Vaccine Safety Datalink. Vaccine. 2022 May 1;40(22):3064-3071. Epub 2022 Apr 8.
- Hanson KE, Goddard K, Lewis N, Fireman B, Myers TR, Bakshi N, Weintraub E, Donahue JG, Nelson JC, Xu S, Glanz JM, Williams JTB, Alpern JD, Klein NP. Incidence of Guillain-Barré Syndrome after COVID-19 Vaccination in the Vaccine Safety Datalink. JAMA Network Open. 2022 Apr 1;5(4):e228879.
- Xu S, Hong V, Sy LS, Glenn SC, Ryan DS, Morrissette KL, Nelson JC, Hambidge SJ, Crane B, Zerbo O, DeSilva MB, Glanz JM, Donahue JG, Lile E, Duffy J, Qian L. Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic. Vaccine. 2022 April 18;S0264-410X922)00464-9. Online ahead of print.
- Moro PL, Olson CK, Clark E, Marquez P, Strid P, Ellington S, Zhang B, Mba-Jonas A, Alimchandani M, Cragan J, Moore C. Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 – October 2021. Vaccine. 2022 May 26; 40(24):3389-3394. Epub 2022 Apr 12.
- DeSilva M, Haapala J, Vazquez-Benitez G, Vesco KK, Daley MF, Getahun D, Zerbo O, Naleway A, Nelson JC, Williams JTB, Hambidge SJ, Boyce TG, Fuller CC, Lipkind HS, Weintraub E, McNeil MM, Kharbanda EO. Evaluation of Acute Adverse Events after Covid-19 Vaccination during Pregnancy. N Engl J Med. 2022 Jun 22. DOI: 10.1056/NEJMc2205276. Epub ahead of print.
- Weintraub ES, Oster ME, Klein NP. Myocarditis or Pericarditis Following mRNA COVID-19 Vaccination. JAMA. 2022 Jun 24; 5(6):e2218512. doi:10.1001/jamanetworkopen.2022.18512
- Hause AM, Zhang B, Yue X, Marquez P, Myers TR, Parker C, Gee J, Su J, Shimabukuro TT, Shay DK. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Netw Open 2022 Jul 1;5(7):e2222241.doi: 10.1001/jamanetworkopen.2022.22241.
- Fleming-Dutra KE, Wallace M, Moulia DL, Twentyman E, Roper LE, Hall E, Link-Gelles R, Godfrey M, Woodworth KR, Anderson TC, Rubis AB, Shanley E III, Jones JM, Morgan RL, Brooks O, Talbot HK, Lee GM, Bell BP, Daley M, Meyer S, Oliver SE. Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022. MMWR Morb Mortal Wkly Rep. 2022 Jul 1; 71(26);859–868.
- Hause AM, Shay DK, Klein NP, Abara WE, Baggs J, Cortese MM, Fireman B, Gee J, Glanz JM, Goddard K, Hanson KE, Hugueley B, Kenigsberg T, Kharbanda EO, Lewin B, Lewis N, Marquez P, Myers T, Naleway A, Nelson JC, Su JR, Thompson D, Olubajo B, Oster ME, Weintraub ES, Williams JTB, Yousaf AR, Zerbo O, Zhang B, Shimabukuro TT. Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years. Pediatrics. 2022 Jul 14. https://doi.org/10.1542/peds.2022-057313.
- Hause AM, Baggs J, Marquez P, Abara WE, Baumblatt JG, Thompson D, Su JR, Myers TR, Gee J, Shimabukuro TT, Shay DK. Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status — United States, January 12, 2022–March 28, 2022. MMWR Morb Mortal Wkly Rep. 2022 Jul 15; 71(28);899–903.
- Hause AM, Baggs J, Marquez P, Abara WE, Baumblatt J, Blanc PG, Su JR, Hugueley B, Parker C, Myers TR, Gee J, Shimabukuro TT, Shay DK. Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022. MMWR Morb Mortal Wkly Rep. 2022 Jul 29;71(30);971–976.
- Twentyman E, Wallace M, Roper LE, Anderson TC, Rubis AB, Fleming-Dutra KE, Hall E, Hsu J, Rosenblum HG, Godfrey M, Archer WR, Moulia DL, Daniel L, Brooks O, Talbot HK, Lee GM, Bell BP, Daley M, Meyer S, Oliver SE. Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years — United States, July 2022. MMWR Morb Mortal Wkly Rep. 2022 Aug 5;71(31);988–992
- Wong KK, Heilig CM, Hause A, Myers TR, Olson CK, Gee J, Marquez P, Strid P, Shay DK. Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study. Lancet Digit Health. 2022 Aug 9; S2589-7500(22)00125-X. Online ahead of print.
- Tartof SY, Malden DE, Liu ILA, Sy LS, Lewin BJ, Williams JTB, Hambidge SJ, Alpern JD, Daley MF, Nelson JC, McClure D, Zerbo O, Henninger ML, Fuller C, Weintraub E, Saydeh S, Qian L. Health Care Utilization in the 6 Months Following SARS-CoV-2 Infection. JAMA Network. 2022 Aug 12 ;5(8):e2225657. doi:10.1001/jamanetworkopen.2022.25657.
- Goddard K, Lewis N, Fireman B, Weintraub E, Shimabukuro T, Zerbo O, Boyce TG, Oster ME, Hanson KE, Donahue JG, Ross P, Naleway A, Nelson JC, Lewin B, Glanz JM, Williams JTB, Kharbanda EO, Yih WK, Klein NP. Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination. Vaccine. 2022 Aug 19; 40(35):5153-5159. Epub 2022 Jul 12.
- Hause AM, Baggs J, Marquez P, Myers TR, Su JR, Hugueley B, Thompson D, Gee J, Shimabukuro TT, Shay DK. Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years — United States, May 17–July 31, 2022. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33);1047–1051.
- Moro PL, Olson CK, Zhang B, Marquez P, Strid P. Safety of Booster Doses of Coronavirus Disease 2019 (COVID-19) Vaccine in Pregnancy in the Vaccine Adverse Event Reporting System. Obstet Gynecol.2022 Sept 1; 40(3):421-427.
- Hause AM, Marquez P, Zhang B, Myers TR, Gee J, Su JR, Parker C, Thompson D, Panchanathan SS, Shimabukuro TT, Shay DK. COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18, 2022–August 21, 2022. MMWR Morb Mortal Wkly Rep. 2022 Sep 2;71(35);1115-1120.
- Kracalik I, Oster ME, Broder KR, Cortese MM, Glover M, Shields K, Creech CB, Romanson B, Novosad S, Soslow J, Walter EB, Marquez P, Dendy JM, Woo J, Valderrama AL, Ramirez-Cardenas A, Assefa A, Campbell MJ, Su JR, Magill SS, Shay DK, Shimabukuro TT, Basavaraju SV. Outcomes at least 90 days onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. Lancet Child Adolesc Health. 2022 Nov 6;6(11):788-798. Epub 2022 Sept 22.
- Daley MF, Reifler LM, Glanz JM, Hambidge SJ, Getahun D, Irving SA, Nordin JD, McClure DL, Klein NP, Jackson ML, Duffy J, DeStefano F. Association Between Aluminum Exposure from Vaccines Before Age 24 Months and Persistent Asthma at Age 24-59 Months [PDF – 10 Pages]. Academic Pediatrics. 2022 Sept 27. Online ahead of print.
- Nelson JC, Ulloa-Perez E, Yu O, Cook AJ, Jackson ML, Belongia EA, Daley MF, Harpaz R, Kharbanda EO, Klein NP, Naleway AL, Tseng HF, Weintraub ES, Duffy J, Yih WK, Jackson LA. Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data. Am J Epidemiol. 2022 Oct 4. doi: 10.1093/aje/kwac170. Online ahead of print.
- Goddard K, Hanson KE, Lewis N, Weintraub E, Fireman B, Klein NP. Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States. Annals of Internal Medicine. 2022 Oct 4. doi.org/10.7326/M22-2274.
- Hause AM, Marquez P, Zhang B, Myers TR, Gee J, Su JR, Blanc PG, Thomas A, Thompson D, Shimabukuro TT, Shay DK. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥ 12 Years – United States, August 31 – October 23, 2022. MMWR Morb Mortal Wkly Rep. 2022 Nov 4; 71(44);1401–1406.
- Tompkins LK, Baggs J, Myers TR, Gee JM, Marquez PL, Kennedy SB, Peake D, Dua D, Hause AM, Strid P, Abara W, Rossetti R, Shimabukuro TT, Shay DK. Association between history of SARS-CoV-2 infection and severe systemic adverse events after mRNA COVID-19 vaccination among U.S. adults. Vaccine. 2022 Dec 12;S0264-410X(22)01342-1. Online ahead of print.
- Haq K, Anyalechi EG, Schlaudecker EP, McKay R, Kamidani S, Manos C, Oster ME. Multiple MIS-C Readmissions and Giant Coronary Aneurysm After COVID-19 Illness and Vaccination: A Case Report. The Pediatric Infectious Disease Journal. 2022 Dec 16; DOI: 10.1097/INF.0000000000003801. Online ahead of print.
- Malden DE, Gee J, Glenn S, Li Z, Mercado C, Ogun OA, Kim S, Lewin BJ, Ackerson BK, Jazwa A, Weintraub ES, McNeil MM, Tartof S. Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system. Vaccine. 2023 Jan 9; https://doi.org/10.1016/j.vaccine.2022.10.079. Online ahead of print.
- Moro PL, Zhang B, Ennulat C, Harris M, McVey R, Woody G, Marquez P, McNeil MM, Su JR. Safety of Co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the Vaccine Adverse Event Reporting System (VAERS) during July 1, 2021 – June 30, 2022. Vaccine. 2023 Jan 9; https://doi.org/10.1016/j.vaccine.2022.12.069 Online ahead of print.
- Yih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson J, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink. Vaccine. 2023 Jan 9; https://doi.org/10.1016/j.vaccine.2022.11.053. Online ahead of print.
- Xu S, Huang R, Sy LS, Hong V, Glenn SC, Ryan DS, Morrissette K, Vazquez-Benitez G, Glanz JM, Klein NP, Fireman B, McClure D, Liles EG, Weintraub ES, Tseng HF, Qian L. A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination. Vaccine. 2023 Jan 16; https://doi.org/10.1016/j.vaccine.2022.12.036. Online ahead of print.
- Yih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson J, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. A broad assessment of covid-19 vaccine safety using tree-based data-mining in the vaccine safety datalink. Vaccine. 2023 Jan 16; https://doi.org/10.1016/j.vaccine.2022.12.026. Online ahead of print.
- Myers TR, Marquez PL, Gee JM, Hause AM, Panagiotakopoulos L, Zhang B, McCullum I, Licata C, Olson CK, Rahman S, Kennedy SB, Cardozo M, Patel CR, Maxwell L, Kallman JR, Shay DK, Shimabukuro TT. The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. Vaccine. 2023 Jan 23; https://doi.org/10.1016/j.vaccine.2022.12.031 Online ahead of print.
- Abara WE, Gee J, Marquez P, Woo J, Myers TR, DeSantis A, Baumblatt JAG, Woo EJ, Thompson D, Nair N, Su JR, Shimabukuro TT, Shay DK. Reports of Guillain-Barré Syndrome After COVID-19 Vaccination in the United States. JAMA Network. 2023 Feb 1;6(2):e2253845. doi:10.1001/jamanetworkopen.2022.53845.
- Cortese MM, Taylor AW, Akinbami LJ, Thames-Allen A, Yousaf AR, Campbell AP, Maloney SA, Harrington TA, Anyalechi EG, Munshi D, Kamidani S, Curtis CR, McCormick DW, Staat MA, Edwards KM, Creech CB, Museru O, Marquez P, Thompson D, Su JR, Schlaudecker EP, Broder KR. Surveillance For Multisystem Inflammatory Syndrome in US Children Aged 5-11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022. J Infect Dis. 2023 Feb 23;jiad051. Online ahead of print.
- Vazquez-Benitez G, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson JC, Williams JTB, Hambidge SJ, Donahue J, Fuller CC, Weintraub ES, Olson C, Kharbanda EO. COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion. American Journal of Epidemiology. 2023 Mar 16;kwad059. Online ahead of print.
- Kharbanda EO, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Vesco KK, Daley MF, Donahue JG, Getahun D, Hambidge SJ, Irving SA, Klein NP, Nelson JC, Weintraub ES, Williams JTB, Vazquez-Benitez G. COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion. JAMA Network Open. 2023 May 19;6(5):e2314350.
- Miller ER, Moro PL, Shimabukuro TT, Carlock G, Davis SN, Freeborn EM, Roberts AL, Gee J, Taylor AW, Gallego R, Suragh T, Su JR. COVID-19 vaccine safety inquiries to the centers for disease control and prevention immunization safety office. Vaccine. 2023 Jun 19; https://doi.org/10.1016/j.vaccine.2023.05.054 Online ahead of print.
- Zhou ZH, Cortese MM, Fang JL, Wood R, Hummell DS, Risma KA, Norton AE, KuKuruga M, Kirshner S, Rabin RL, Agarabi C, Staat MA, Halasa N, Ware RE, Stahl A, McMahon M, Browning P, Maniatis P, Bolcen S, Edwards KM, Su JR, Dharmarajan S, Forshee R, Broder KR, Anderson S, Kozlowski S. Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination. Vaccine. 2023 Jun 23; https://doi.org/10.1016/j.vaccine.2023.05.029 Online ahead of print.
- Schmader KE, Liu CK, Flannery B, Rountree W, Auerbach H, Barnett ED, Schlaudecker EP, Todd CA, Poniewierski M, Staat MA, Harrington T, Li R, Broder KR, Walter EB. Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial. Immun Ageing. 2023 Jul 1; 20(1):30. doi: 10.1186/s12979-023-00355-7.
- Woo EJ, Gee J, Marquez P, Baggs J, Abara WE, McNeil MM, Dimova RB, Su JR. Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022. Vaccine. 2023 Jul 5; https://doi.org/10.1016/j.vaccine.2023.06.023 Online ahead of print.
- Moro PL, Zhang B, Marquez P, Reich J. Post-marketing Safety Surveillance of Hexavalent Vaccine in the Vaccine Adverse Event Reporting Systemnt Reporting System. Journal of Pediatrics. 2023 Jul 28. Doi.org/10.1016/j.peds.2023.113643. Online ahead of print.
- Romanson B, Moro PL, Su JR, Marquez P, Nair N, Day B, DeSantis A, Shimabukuro TT. Notes from the Field: Safety Monitoring of Novavax COVID-19 Vaccine Among Persons Aged ≥ 12 Years – United States, July 13, 2022 – March 13, 2023July 13, 2022 – March 13, 2023. MMWR Morb Mortal Wkly Rep. 2023 Aug 4. 72(31);850-851.
- Yih WK, Daley MF, Duffy J, Fireman B, McClure DL, Nelson JC, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. Safety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety DatalinkSafety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety Datalink. Vaccine. 2023 Aug 14; https://doi.org/10.1016/j.vaccine.2023.07.10 Online ahead of print.
- Kenigsberg TA, Goddard K, Hanson KE, Lewis N, Klein N, Irving SA, Naleway AL, Crane B, Kauffman TL, Xu S, Daley MF, Hurley LP, Kaiser R, Jackson LA, Jazwa A, Weintraub ES. Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccinesSimultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines. Vaccine. 2023 Sep 7; https://doi.org/10.1016/j.vaccine.2023.08.023. Online ahead of print.
- Kauffman TL, Irving SA, Brooks N, Vesco KK, Slaughter M, Smith N, Tepper NK, Olson CK, Weintraub ES, Naleway AL, Vaccine Safety Datalink Menstrual Irregularities Workgroup. Postmenopausal bleeding after COVID-19 vaccination. Am J Obstet Gynecol, 2023 Sept 17; S0002-9378(23)00613-0. Online ahead of print. https://doi.org/10.1016/j.ajog.2023.09.007.
- Phillips A, Jiang Y, Walsh D, Andrews N, Artama M, Clothier H, Cullen L, Deng L, Escolano S, Gentile A, Gidding G, Giglio N, Junker T, Huang W, Janjua N, Kwong J, Li J, Nasreen S, Naus M, Naveed Z, Pillsbury A, Stowe J, Vo T, Buttery J, Petousis-Harris H, Black S, Hviid A. Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis. Vaccine. 2023 Oct 6;41(42):6227-6238. Online ahead of print.
- See I, Su JR, Lale A, et al. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA. 2021;325(24):2448–2456. doi:10.1001/jama.2021.7517
- Isaac See, Allison Lale, Paige Marquez, et al. Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination—United States, December 2020 to August 2021. Ann Intern Med.2022;175:513-522. [Epub 18 January 2022]. doi:10.7326/M21-4502
- https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
- Oliver, S. E., Wallace, M., See, I., Mbaeyi, S., Godfrey, M., Hadler, S. C., Jatlaoui, T. C., Twentyman, E., Hughes, M. M., Rao, A. K., Fiore, A., Su, J. R., Broder, K. R., Shimabukuro, T., Lale, A., Shay, D. K., Markowitz, L. E., Wharton, M., Bell, B. P., Brooks, O., ... Daley, M. F. (2022). Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR. Morbidity and mortality weekly report, 71(3), 90–95. https://doi.org/10.15585/mmwr.mm7103a4