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Vaccine Safety








Coronavirus Disease 2019 (COVID-19) Vaccines						Print
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			Available Vaccines, Package Inserts, and FactsheetsCommon Side EffectsA Closer Look at the Safety DataHow CDC Monitors Vaccine SafetyRelated Scientific Articles
		
Safety InformationAbout Coronavirus Disease 2019 (COVID-19)**Coronavirus disease 2019**, or (COVID-19), is a respiratory disease caused by the SARS-CoV-2 virus, a coronavirus discovered in 2019. The virus 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. Everyone 6 months and older should receive at least one dose of an updated COVID-19 vaccine to protect against serious illness, hospitalization, and death.
Learn more about COVID-19.
COVID-19 vaccines can help reduce the risk of illness from COVID-19 and its potentially serious complications.Vaccine Information StatementsVaccine Information Statements (VISs) are information sheets produced by CDC that explain both the benefits and risks of a vaccine.
Vaccine Information Statement | Current VISs | CDCVISs are available for mRNA vaccines for people ages 12 years and older. For more information, go toCOVID-19 vaccine EUA Factsheets.Pfizer-BioNTech COVID-19 vaccineModerna COVID-19 vaccineNovavax COVID-19 vaccineAvailable Vaccines, Package Inserts, and Factsheets
There are two types of COVID-19 vaccines approved for use or authorized for emergency use by the Food and Drug Administration (FDA) in the United States. For most people, these vaccines are given as an injection in the muscle of the upper arm. For infants and toddlers, these vaccines are usually given as an injection in the thigh muscle.
Pfizer-BioNTech (Comirnaty®) and Moderna (Spikevax®) – are 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. These vaccines are authorized for children ages 6 months through 11 years and approved for people ages 12 years and older. CDC recommends everyone 6 months and older receive at least one dose of an updated COVID-19 vaccine.
Novavax – is 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. It is authorized for people 12 years and older.To learn more about how the different types of COVID-19 vaccines work, go toUnderstanding How COVID-19 Vaccines Work | CDC.Talk with your healthcare provider about vaccines.
They can answer questions and offer advice based on your specific health needs.Child and Adult Immunization Schedules
Get CDC’s official recommended immunization schedules for children, adolescents, and adults.Manufacturer Package Inserts and FactsheetsThere are currently two mRNA COVID-19 vaccines available in the United States that have full approval from the United States Food and Drug Administration (FDA) for use in people ages 12 and older (Pfizer-BioNTech [Comirnaty®] and Moderna [Spikevax®]). These vaccines are authorized for emergency use in children ages 6 months through 11 years. They are designed to protect people ages 6 months and older against COVID-19.
Novavax, a protein subunit COVID-19 vaccine, is also available in the United States. Novavax is authorized for use in people ages 12 years and older.
These vaccines have been updated for 2023-2024 to protect against circulating variants of the virus that causes COVID-19. CDC recommends that people receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination.
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Fully Licensed U.S. Food and Drug Administration (FDA) Vaccines
	Comirnaty (2023-2024 Formula) – [PDF – 37 Pages]: FDA approved this Pfizer-BioNTech COVID-19, mRNA vaccine in 2021. It is approved for use in people 12 years of age and older. This is a single dose injection.
Spikevax (2023-2024 Formula) – [PDF – 45 Pages]: FDA approved this Moderna COVID-19, mRNA vaccine in 2022. It is approved for use in people 12 years of age and older.Emergency Use Authorization Vaccines
	Pfizer-BioNTech COVID-19 vaccine (2023-2024 Formula) – [PDF – 61 Pages]: FDA authorized this vaccine for emergency use in children ages 6 months to 11 years.
Moderna COVID-19 vaccine (2023-2024 Formula) – [PDF – 55 Pages]: FDA authorized this vaccine for emergency use in children ages 6 months to 11 years.
Novavax COVID-19 vaccine (2023-2024 Formula) – [PDF – 50 Pages]: FDA authorized this vaccine for emergency use in people ages 12 years and older.Top of PageCommon Side Effects
Vaccines, like any medicine, can have side effects. Side effects after getting a COVID-19 vaccine vary from person to person. The most common side effects are usually mild, such as soreness in the area where the shot was given.Important!

**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.**If such reactions occur, seek immediate medical attention.**mRNA Vaccine (FDA Approved and Emergency Use) Pfizer-BioNTech and Moderna**Common Side Effects**
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
**Common Side Effects**
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
**Common Side Effects**
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

Who Should Not Get an mRNA Vaccine
**People should not get an mRNA COVID-19 vaccine if they:**
Are younger than 6 months
Have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to an ingredient of the mRNA COVID-19 vaccine**People should talk to their healthcare provider before getting an mRNA COVID-19 vaccine if they:**
Have had an immediate allergic reaction to a previous dose of an mRNA COVID-19 vaccine that was not severe
Have had an allergic reaction to an ingredient in the mRNA COVID-19 vaccine that was not severe
Have a recent history of COVID-19 infection
Are sick with a moderate or severe illness, with or without a fever
Have a history of MIS-C or MIS-A
Have a history of myocarditis or pericarditis within 3 weeks after a dose of any COVID-19 vaccineProtein Subunit Vaccine (Emergency Use) Novavax**Common Side Effects**
Pain, soreness, redness, swelling at injection site
Fatigue
Headache
Muscle pain
Joint pain
Chills
Fever
Nausea/vomiting
**Common Side Effects**
Pain, soreness, redness, swelling at injection site
Fatigue
Headache
Muscle pain
Joint pain
Chills
Fever
Nausea/vomiting
**Common Side Effects**
Pain, soreness, redness, swelling at injection site
Fatigue
Headache
Muscle pain
Joint pain
Chills
Fever
Nausea/vomiting

Who Should Not Get a Protein Subunit Vaccine
**People should not get a protein subunit COVID-19 vaccine if they:**
Are younger than 12 years
Have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to an ingredient of Novavax vaccine**People should talk to their healthcare provider before getting a protein subunit COVID-19 vaccine if they:**
Have had an immediate allergic reaction to a previous dose of a Novavax COVID-19 vaccine that was not severe
Have had an allergic reaction to an ingredient in the Novavax COVID-19 vaccine that was not severe
Have a recent history of COVID-19 infection
Are sick with a moderate or severe illness, with or without a fever
Have a history of MIS-C or MIS-A
Have a history of myocarditis or pericarditis within 3 weeks after a dose of any COVID-19 vaccineMore InformationCOVID-19 Vaccination: What everyone should knowWhat everyone should know about COVID-19 and the vaccines that can protect against it.Who Should Not Get Vaccinated?Some people should not get certain vaccines or should wait before getting them. Read the CDC guidelines for each vaccine.COVID-19 ACIP Vaccine RecommendationsOfficial recommendations for COVID-19 vaccines from the Advisory Committee on Immunization Practices (ACIP).COVID-19 Vaccination Provider Requirements and SupportGuidance for healthcare professionals about the CDC COVID-19 vaccination program.A Closer Look at the Safety DataCOVID-19 vaccines meet the Food and Drug Administration’s (FDA’s) standards for safety and effectiveness. In rare cases, people have experienced serious health events after COVID-19 vaccination. Any health problem that happens after vaccination is considered an adverse event following immunization. An adverse 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.
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.
**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.
The evidence suggests that, although rare, these events are linked to certain types of COVID-19 vaccinations that were administered.
Learn more about theseSelected Adverse Events Reported after COVID-19 Vaccination.**Which adverse events are considered “serious?”**
By regulation, an adverse event is defined as serious if it involves any of the following outcomes:
Death
A life-threatening adverse event
A persistent or significant disability or incapacity
A congenital anomaly or birth defect
Hospitalization, or prolongation of existing hospitalizationHow CDC Monitors the Safety of COVID-19 VaccinesCDC and FDA monitor the safety of vaccines after they are approved. If a problem is found with a vaccine, CDC and FDA will inform health officials, healthcare providers, and the public.Top of PageRelated Scientific Articles
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2023
	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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.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.
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.
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.2022
	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.
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.
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.
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.
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.
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.
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.
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.
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, 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.
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.
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.
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.
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
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.
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, 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.
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, 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.
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
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.
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.
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.
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.
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.
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-safe *Lancet Infect Dis*.2022 Mar 7;S1473-3099(22)0054-8. Online ahead of print.
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, 2022 *MMWR Morb Mortal Wkly Rep* 2022 Feb 11;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.
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.2021
	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.
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.
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, 2021 *MMWR Morb Mortal Wkly Rep.* epub 2021 Sep 28.
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 Vaccination *JAMA* 2021 Sept 3. Doi:10.1001/jama.2021.15072.
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 2021 *MMWR Morb Mortal Wkly Rep.* 2021 Aug 10.
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.
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 vaccines *Vaccine* 2021 Jun 23;39(28):3666-3677. Epub 2021 May 14.
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 Persons *N Engl J Med* 2021 April 21. DOI: 10.1056/NEJMoa2104983 Epub ahead of print.
Chapin-Bardales J, Gee J, Myers T. Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines *JAMA Insights*2021 April 5. doi:10.1001/jama.2021.5374 Epub ahead of print.
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, 2021 *MMWR Morb Mortal Wkly Rep.* 2021 Feb 26;70;283-288.
							
					
							Last Reviewed:  February 12, 2024, 12:00 AM						Source: 	Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP)
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