V-safe Publications
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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.
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.
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.
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.
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.
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.
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.
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.
Rosenblum HG, Gee J, Liu R, Marquez PL, Zhang B, Strid P, Abara WE, McNeil MM, Myers TR, Hause AM, Su JR, Markowitz LE, Shimabukuro TT, Shay DK. 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. Lancet Infect Dis. 2022 Mar 7; S1473-3099(22)00054-8. Online ahead of print.
Hause AM, Baggs J, Marquez P, Abara WE, Olubajo B, Myers TR, Su JR, Thompson D, Gee J, Shimabukuro TT, Shay DK. 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 Mar 1;71(9);347–351.
Hause AM, Baggs J, Marquez P, Myers TR, Su JR, Blanc PG, Gwira 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 18; 71(7);249–254.
Hause AM, Baggs J, Marquez P, Myers TR, Gee J, Su JR, Zhang B, Thompson D, Shimabukuro TT, Shay DK. COVID-19 Vaccine Safety in Children Ages 5-11 years — United States, November 3-December 19, 2021. MMWR Morb Mort Wkly Rep. 2021 Dec 31:70(5152);1755-1760.
On October 29, 2021, the FDA expanded emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include children ages 5-11 years. Once the EUA was in place, researchers began reviewing vaccine safety data for this age group, collected through the Vaccine Adverse Event Reporting System (VAERS) and v-safe. From November 3 through December 19, 2021, around 8.7 million doses of Pfizer vaccine were administered to children ages 5-11 years. During that time, VAERS received 4,249 reports of adverse events following vaccination for children in that age group, 98% of which were non-serious. There were 11 verified cases of myocarditis. Of the over 42,000 children enrolled in v-safe, 70% recorded a second dose. Local reactions (symptoms around the injection site) and systemic reactions (fever, headache, fatigue) following dose 2 of Pfizer vaccination among this age group were reported less frequently than reactions reported among children ages 12-15 years. The initial safety findings showed no unusual patterns of adverse events and that the benefits of COVID-19 vaccination continue to outweigh the risks. CDC and FDA will continue to monitor COVID-19 vaccine safety, communicate findings, and use vaccine safety data to inform vaccination recommendations.
Moro PL, Panagiotakopoulos L, Oduyebo T, Olson CK, Myers T. Monitoring the safety of COVID-19 vaccines in pregnancy in the US. Human Vaccines & Immunotherapies. 2021 Nov 10. doi.org/10.1080/21645515.2021.1984132.
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.
In this review of v-safe vaccine safety data, researchers analyzed surveys of people who received their mRNA vaccine from December 14, 2020, through March 14, 2021. V-safe is a vaccine safety monitoring system that uses text messages and web surveys to collect information on health impacts reported after receipt of COVID-19 vaccines. During this time period, more than 4.7 million participants received one dose of an mRNA vaccine (Pfizer-BioNTech or Moderna), and over 2.9 million received a second dose. Most participants reported either a local reaction at the injection site (68.5% after dose 1; 72.9% after dose 2) or a systemic reaction, such as fever, headache, muscle ache and fatigue (50.6% after dose 1; 69.5% after dose 2). Researchers found that these side effects were reported more frequently among those who received Moderna than those who received Pfizer-BioNTech. An analysis of surveys reported on day 14 after vaccination indicated that new or worsening local and systemic reactions were uncommon during the second week following both dose 1 and dose 2. CDC will continue to closely monitor the safety of COVID-19 vaccines.
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.
On August 12, 2021, the Food and Drug Administration (FDA) expanded the Emergency Use Authorizations for Pfizer-BioNTech and Moderna (mRNA) COVID-19 vaccines to include an additional dose following the 2-dose vaccination series to those with compromised immune systems. From August 12 through September 19, over 22,000 v-safe enrollees reported an additional COVID-19 dose after completing the primary 2-dose mRNA vaccination series, most with the same vaccine. Among those who completed surveys for all 3 doses, local reactions (like pain or swelling where the shot was given) were reported slightly more after dose 3 compared with after dose 2 (79% vs. 78%), while reported systemic reactions (tiredness, headache) were slightly less common after dose 3 (74% vs. 77%). These side effects were mostly mild to moderate and short-lived. These findings did not show unexpected patterns of adverse events following an additional dose of COVID-19 vaccines. CDC will continue to monitor the safety of additional doses of COVID-19 vaccines and provide data to guide recommendations and protect the public’s health.
Hause AM, Gee J, Baggs J, Abara WE, Marquez P, Thompson D, Su JR, Licata C, Rosenblum HG, Myers TR, Shimabukuro TT, Shay DK. COVID-19 Vaccine Safety in Adolescents—United States, December 14, 2020—July 16, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 30.
As of July 2021, Pfizer-BioNTech COVID-19 Vaccine (Pfizer-BioNTech) is the only COVID-19 vaccine authorized for use in adolescents (people aged 12–17 years). To evaluate the safety of Pfizer-BioNTech in adolescents, researchers reviewed data collected from VAERS and v-safe between December 14, 2020 through July 16, 2021. Over 8.9 million Pfizer-BioNTech doses were administered to adolescents ages 12-17. VAERS received 9,246 reports of adverse events in adolescents; over 90% of reports were non-serious. Myocarditis was reported in 4.3% (397) of all VAERS reports. Of the 129,000 adolescents who enrolled in v-safe, the most frequently reported side effects included injection site pain, fatigue, headache, and weakness. With the exception of myocarditis, the safety findings were similar to what was observed during preauthorization trials. CDC and FDA are actively monitoring the safety of COVID-19 vaccines. Serious adverse events after COVID-19 vaccination are rare, and CDC continues to recommend everyone 12 years and older get vaccinated as soon as possible to help protect against COVID-19.
Hause AM, Gee J, Baggs J, Abara WE, Marquez P, Thompson D, Su JR, Licata C, Rosenblum HG, Myers TR, Shimabukuro TT, Shay DK. COVID-19 Vaccine Safety in Adolescents—United States, December 14, 2020—July 16, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 30.
As of July 2021, Pfizer-BioNTech COVID-19 Vaccine (Pfizer-BioNTech) is the only COVID-19 vaccine authorized for use in adolescents (people aged 12–17 years). To evaluate the safety of Pfizer-BioNTech in adolescents, researchers reviewed data collected from VAERS and v-safe between December 14, 2020 through July 16, 2021. Over 8.9 million Pfizer-BioNTech doses were administered to adolescents ages 12-17. VAERS received 9,246 reports of adverse events in adolescents; over 90% of reports were non-serious. Myocarditis was reported in 4.3% (397) of all VAERS reports. Of the 129,000 adolescents who enrolled in v-safe, the most frequently reported side effects included injection site pain, fatigue, headache, and weakness. With the exception of myocarditis, the safety findings were similar to what was observed during preauthorization trials. CDC and FDA are actively monitoring the safety of COVID-19 vaccines. Serious adverse events after COVID-19 vaccination are rare, and CDC continues to recommend everyone 12 years and older get vaccinated as soon as possible to help protect against COVID-19.
Shay DK, Gee J, Su JR, Myers TR, Marquez P, Liu R, Zhang B, Licata C, Clark TA, Shimabukuro TT. Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March-April 2021. MMWR Morb Mortal Wkly Rep. 2021 April 30. Epub ahead of print.
Johnson & Johnson’s Janssen COVID-19 vaccine was authorized by FDA for emergency use on February 27, 2021. By April 21, nearly 8 million doses of the Janssen COVID-19 vaccine had been administered. CDC researchers reviewed safety monitoring data from VAERS and the v-safe after-vaccination health checker, and found 97% of reported reactions after vaccination, such as headache, fever, chills, injection site pain, and fatigue, were nonserious and consistent with clinical trials data. CDC and FDA issued a pause of the Janssen vaccine April 12–23, 2021, after 6 cases of cerebral venous sinus thrombosis (CVST), a serious condition that involves blood clots in the brain, were identified in VAERS. By April 25, a total of 17 thrombotic (blood clots) events with thrombocytopenia (low platelet counts) were reported to VAERS, including 3 thrombotic events not occurring in the brain. CDC and FDA continue to monitor the safety of COVID-19 vaccines, analyzing the risks and benefits of continued use.
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.
Pregnant people were not included in the messenger RNA (mRNA) COVID-19 vaccine clinical trials. Because of the increased risk of severe illness from COVID-19, CDC has provided guidance to pregnant people who may want to get a COVID-19 vaccine. The safety of mRNA vaccines in pregnant people is monitored through 3 systems: v-safe after vaccination health checker, the v-safe pregnancy registry and VAERS. From December 14, 2020 through February 28, 2021, 35,691 v-safe participants ages 16 to 54 identified as pregnant. Injection site pain was commonly reported. Of those, 3,958 enrolled in the v-safe pregnancy registry: 827 completed pregnancy; 712 (86.1%) had live births, with most vaccinations completed in the 3rd trimester. In the VAERS reports following mRNA vaccinations, 155 (70.1%) were nonpregnancy specific; 66 (29.9%) were pregnancy and neonatal specific events. The analysis of v-safe and VAERS data did not show any safety concerns among pregnant persons who received mRNA COVID-19 vaccines.
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.
CDC created v-safe, a smartphone-based tool, to monitor in near-real time the safety of COVID-19 vaccines authorized by FDA for emergency use. V-safe uses text messaging and web surveys to provide personalized health check-ins after COVID-19 vaccination. Researchers reviewed data collected from v-safe from December 14, 2020 to February 28, 2021, including side effects and reactions to the mRNA COVID-19 vaccines. Over 3.6 million v-safe participants completed at least one health check-in after the first dose and over 1.9 million after the second dose. Injection site pain was commonly reported after first (70%) and second doses (75%) of either mRNA vaccine. Systemic reactions, such as fatigue, headache, muscle pain, chills, fever, and joint pain were the top symptoms reported by participants after the first mRNA vaccine dose. These reports increased substantially after the second dose among both mRNA vaccines. People aged 65 years and older reported fewer reactions than younger people. While v-safe is voluntary and includes less than 10% of people vaccinated, reported reactions to the mRNA vaccines were consistent with results observed in clinical trials.</p
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.
The U.S. FDA authorized two COVID-19 vaccines for emergency use in December 2020: Pfizer-BioNTech and Moderna. During clinical trials, there were reports of local reactions where the shot was given, and systemic reactions affecting other parts of the body. Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history. From December 14, 2020 through January 13, 2021, almost 14 million vaccine doses were distributed. During that time, over 1.6 million vaccine recipients enrolled in v-safe, and VAERS received 6,994 reports of adverse events following vaccination. About 91% of VAERS reports were non-serious; commonly reported symptoms included headache (22.4%), fatigue (16.5%) and dizziness (16.5%). V-safe enrollees reported similar local and systemic reactions. While deaths were reported to VAERS, available documentation did not suggest a causal link between the vaccine and death. Overall, no unusual or unexpected reporting patterns were detected.