5 Vaccine-linked myocarditis is less likely to cause lingering heart problems than myocarditis due to COVID-19 illness. Since June 2020, ACIP has convened 15 public meetings to review data on COVID-19 epidemiology and use of COVID-19 vaccines. Based on ACIPs conclusion regarding the benefit-risk assessment on June 23, 2021, COVID-19 vaccination continues to be recommended for all persons aged 12 years under the FDAs EUA. You will be subject to the destination website's privacy policy when you follow the link. Cases of myocarditis and pericarditis, although rare, have occurred more often in younger men (adolescents or young adults) and after the second dose, typically within a few days after . FDA Is Looking Again at Heart Inflammation Linked to Moderna Vaccine Although Rare, New Data Suggests Higher Rate of Myocarditis - BioSpace endobj Trends in acute myocarditis related pediatric hospitalizations in the United States, 20072016. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Comparison of COVID-19 Vaccine-Associated Myocarditis and Viral Myocarditis Pathology. Among males aged 30 years, 15,300 COVID-19 cases, 4,598 hospitalizations, 1,242 ICU admissions, and 700 deaths could be prevented, compared with three to four expected myocarditis cases after COVID-19 vaccination. In those aged under 18 years, the reported rate for heart inflammation (myocarditis and pericarditis) was 13 per million first doses and 8 per million second doses of the monovalent. References to non-CDC sites on the Internet are Law, Y. M., Lal, A. K., Chen, S., ihkov, D., Cooper, L. T., Jr, Deshpande, S., Godown, J., Grosse-Wortmann, L., Robinson, J. D., Towbin, J. official website and that any information you provide is encrypted Am J Cardiol 2021;149:95102. All EUA documents for COVID-19 vaccines, including fact sheets, are available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccinesexternal icon. FLEG: Tens of thousands of people participated in the clinical trials for the COVID-19 vaccines. Currently, about 1,000 cases of myocarditis and pericarditis have been reported after vaccination against COVID-19 with one of the mRNA vaccines, Pfizer/BioNTech or Moderna. Myocarditis among Moderna COVID-19 vaccine recipients - News-Medical.net Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. [Preprint]. Even though the studies were among the largest vaccine trials in history, they were not large enough to detect very rare complications like myocarditis that occur only a few times per million vaccinations. Healthcare Providers: For additional recommendations and clinical guidance, visit Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/risk-benefit-analysis.html. FDA has added information to the Pfizer-BioNTech and Moderna COVID-19 vaccine EUA and fact sheets regarding myocarditis cases that have been reported among vaccine recipients. Block, J. P., Boehmer, T. K., Forrest, C. B., Carton, T. W., Lee, G. M., Ajani, U. The FDA - which generally follows the recommendations of its advisers but is not obligated to do so - is likely to authorize the Moderna vaccine for ages 6-17 soon. Getting vaccinated to prevent severe COVID-19 cuts your risk of myocarditis. They help us to know which pages are the most and least popular and see how visitors move around the site. ** The ACIP COVID-19 Vaccines Safety Technical (VaST) Work Group, comprising independent vaccine safety expert consultants, had also reviewed safety data on myocarditis after receipt of mRNA COVID-19 vaccines at its weekly meetings. <> In a comprehensive analysis of 1,626 myocarditis cases in the U.S. VAERS, Oster, et al., concluded the highest rates of VAM are concentrated in young males, as follows: 6 70.6 per million in males 12-15 years 105.9 per million in males 16-17 years 52.4 per million for Pfizer-BioNTech and 56.3 million for Moderna per million in males 18-24 years. JAMA Netw Open 2021;4:e2116420. The median age of the 323 patients meeting CDCs case definitions was 19 years (range=1229 years); 291 were male, and 32 were female. Myocarditis is more common after covid-19 infection than vaccination Can COVID-19 Vaccines Induce Premature Non-Communicable Diseases: Where Are We Heading to. Most people (95%) who develop myocarditis after receiving a COVID-19 mRNA vaccine have only mild symptoms that go away within a few days.5 Vaccine-linked myocarditis is less likely to cause lingering heart problems than myocarditis due to COVID-19 illness. mRNA Vaccine Technology: A Promising Idea for Fighting HIV, Testing of mRNA HIV vaccines in humans is underway. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine What are the implications for public health practice? Potential cases of postvaccine myocarditis were identified based on reports . Accessed June 29, 2022, from. Myocarditis | American Heart Association Accessibility In a population-based cohort study of adolescents and adults in Denmark who received two doses of the same mRNA vaccine against COVID, the risk of myocarditis or myopericarditis within 28 days. A small number of myocarditis and pericarditis cases have been reported for booster doses. Gurdasani, D., Bhatt, S., Costello, A., Denaxas, S., Flaxman, S., Greenhalgh, T., Griffin, S., Hyde, Z., Katzourakis, A., McKee, M., Michie, S., Ratmann, O., Reicher, S., Scally, G., Tomlinson, C., Yates, C., Ziauddeen, H., & Pagel, C. (2021). The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Moderna Reveals Slightly Higher Rates of Myocarditis in Young - Yahoo! <>/Metadata 2557 0 R/ViewerPreferences 2558 0 R>> Su, J. R., McNeil, M. M., Welsh, K. J., Marquez, P. L., Ng, C., Yan, M., & Cano, M. V. (2021). More information is available, Recommendations for Fully Vaccinated People, Investigating Long-Term Effects of Myocarditis | CDC, Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines, National Center for Immunization and Respiratory Diseases (NCIRD), Possibility of COVID-19 Illness after Vaccination, Investigating Long-Term Effects of Myocarditis, How and Why CDC Measures Vaccine Effectiveness, Monitoring COVID-19 Cases, Hospitalizations, and Deaths by Vaccination Status, Monitoring COVID-19 Vaccine Effectiveness, U.S. Department of Health & Human Services, In both cases, the bodys immune system causes inflammation in response to an infection or some other trigger. PDF Myopericarditis following COVID-19 vaccination: Updates from the Acute clinical courses were generally mild; among 304 hospitalized patients with known clinical outcomes, 95% had been discharged at time of review, and none had died. Myocarditis rates were highest after the second vaccination dose in young males between 12 and 15 years of age (70.7 per million doses of the BNT162b2 vaccine), in adolescent males age 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men age 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine . Among teenaged boys the group with the highest risk of myocarditis after COVID-19 vaccination the risk is between 2 and 5 times higher after SARS-CoV-2 infection than after vaccination.10, A study of children ages 12 to 17 in England estimated that COVID-19 vaccination prevented 4,500 hospitalizations, 300 ICU hospital stays, and 36 deaths during the summer of 2021 when infection rates were high.11, Children with myocarditis linked with vaccination are less likely to be hospitalized, admitted to the ICU, or need ventilator support, compared with children who had myocarditis after a COVID-19 diagnosis. Myocarditis linked with COVID-19 illness may also be more severe because these patients are usually older and have other health conditions that increase their risk of complications. The Researching COVID to Enhance Recovery (RECOVER) Initiative is taking place at 80 centers across the country. The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis. 2022 Jul 13;378:e069445. Heart inflammation, or myocarditis, has been reported as a very rare side effect of COVID-19 vaccines. Symptoms typically include chest pain, dyspnea, or palpitations, although other symptoms might be present, especially in younger children (3). VAERS Data Confirm Myocarditis Risk After mRNA Vaccine Boys more at risk from Pfizer jab side-effect than Covid - The Guardian These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. As of June 11, 2021, approximately 296 million doses of mRNA COVID-19 vaccines had been administered in the United States, with 52 million administered to persons aged 1229 years; of these, 30 million were first and 22 million were second doses. Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 1229 years and 2.4 per million second doses administered to males aged 30 years; reporting rates among females in these age groups were 4.2 and 1.0 per million second doses, respectively. Men under 40 who received a second dose of the Moderna vaccine had a higher risk of myocarditis following vaccination. FDA requires that vaccine providers report to VAERS vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of a COVID-19 vaccine under an EUA. Myocarditis risk significantly higher after COVID-19 infection vs Researchers Identify Four Long COVID Categories. Many people have no side effects at all. All information these cookies collect is aggregated and therefore anonymous. On June 23, 2021, the Advisory Committee on Immunization Practices concluded that the benefits of COVID-19 vaccination to individual persons and at the population level clearly outweighed the risks of myocarditis after vaccination. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Active monitoring includes reviewing data and medical records and evaluating the relationship toCOVID-19vaccination. Viruses. Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada. Most had other health conditions, such as high blood pressure, diabetes, or obesity, that raised their risk for serious COVID-19 illness.4. Saving Lives, Protecting People, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html, https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines, https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html, https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html, https://www.ahajournals.org/doi/10.1161/CIR.0000000000000239?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed#d3e785, https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html, https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/risk-benefit-analysis.html, https://covid.cdc.gov/covid-data-tracker/#demographicsovertime, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html, https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html, https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html, https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://covid.cdc.gov/covid-data-tracker/#demographics, https://www.fda.gov/media/144413/download, https://www.fda.gov/media/144637/download, https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html, https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html, https://doi.org/10.1136/heartjnl-2013-304449, https://doi.org/10.1016/j.amjcard.2021.03.019, https://doi.org/10.1016/j.vaccine.2015.07.035, https://doi.org/10.1001/jamanetworkopen.2021.16420, https://www.sciencedirect.com/science/article/pii/S0735109718388430?via%3Dihub, https://academic.oup.com/eurheartj/article/36/42/2921/2293375, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, Presence of 1 new or worsening of the following clinical symptoms:*, dyspnea, shortness of breath, or pain with breathing. The benefit of vaccination against COVID-19 outweighs the potential risk of myocarditis and pericarditis. I can't remember when I heard about the myocarditis risk with the mRNA vaccines, especially Moderna, but it was definitely by the end of 2021. Members of the Advisory Committee on Immunization Practices COVID-19 Vaccines Work Group: Edward Belongia, Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Institute; Dayna Bowen Matthew, George Washington University Law School; Oliver Brooks, National Medical Association; Jillian Doss-Walker, Indian Health Service; Marci Drees, Society for Healthcare Epidemiology of America; Jeffrey Duchin, Infectious Diseases Society of America; Kathy Kinlaw, Center for Ethics, Emory University; Doran Fink, Food and Drug Administration; Sandra Fryhofer, American Medical Association; Jason M. Goldman, American College of Physicians; Michael Hogue, American Pharmacists Association; Denise Jamieson, American College of Obstetricians and Gynecologists; Jeffery Kelman, Centers for Medicare & Medicaid Services; David Kim, U.S. Department of Health and Human Services; Susan Lett, Council of State and Territorial Epidemiologists; Kendra McMillan, American Nurses Association; Kathleen Neuzil, Center for Vaccine Development and Global Health, University of Maryland School of Medicine; Sean OLeary, American Academy of Pediatrics; Christine Oshansky, Biomedical Advanced Research and Development Authority; Stanley Perlman, Department of Microbiology and Immunology, University of Iowa; Marcus Plescia, Association of State and Territorial Health Officials; Chris Roberts, National Institutes of Health; William Schaffner, National Foundation for Infectious Diseases; Kenneth Schmader, American Geriatrics Society; Bryan Schumacher, Department of Defense; Rob Schechter, Association of Immunization Managers; Jonathan Temte, American Academy of Family Physicians; Peter Szilagyi, University of California, Los Angeles; Matthew Tunis, National Advisory Committee on Immunization Secretariat, Public Health Agency of Canada; Thomas Weiser, Indian Health Service; Matt Zahn, National Association of County and City Health Officials; Rachel Zhang, Food and Drug Administration. Moderna said the majority of the infections were mild. (Pfizer) or mRNA-1273 (Moderna) mRNA vaccine between December 14, 2020, and July 20, 2021. Myocarditis usually goes away on its own with supportive care, including IV fluids, steroid therapy, and medicines to treat disorders of heart rhythm or pumping function. MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services. Current guidelines from the American Heart Association and American College of Cardiology recommend exercise restriction until the heart recovers.. Myocarditis, Pericarditis Rare After COVID-19 Vaccination: EMR Data Males comprised 82% of the myocarditis cases for whom sex was reported. According to the TGA, the current overall estimated rates for the entire population of myocarditis for Pfizer and Moderna are similar - 1.4 cases per 100,000 Pfizer doses versus 1.8 cases per 100,000 Moderna doses. CDC continues to recommend that everyone ages 6 months and older get vaccinated for COVID-19. Vaccination prevents most hospitalizations and deaths due to COVID-19. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. **** https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html, https://covid.cdc.gov/covid-data-tracker/#variant-proportions, ***** https://covid.cdc.gov/covid-data-tracker/#demographics, https://www.fda.gov/media/144413/downloadexternal icon, https://www.fda.gov/media/144637/downloadexternal icon, https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html, ****** https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html, https://vaers.hhs.gov/faq.htmlexternal icon. Heart 2013;99:16814. The Vaccine Safety Datalink: a model for monitoring immunization safety. Montgomery J, Ryan M, Engler R, Hoffman D, McClenathan B, Collins L, Loran D, Hrncir D, Herring K, Platzer M, Adams N, Sanou A, Cooper LT Jr. JAMA Cardiol. Myocarditis typically occurs more commonly in males than in females, and incidence is highest among infants, adolescents, and young adults (1,2). No other disclosures were reported. If you have already gotten the first dose of Pfizer-BioNTech or Moderna vaccine, or if your child has already gotten the first dose of the Pfizer-BioNTech vaccine, its important to get the second dose unless a vaccination provider or your doctor tells you not to get it. OR, infants and children aged <12 years might instead have 2 of the following symptoms: troponin level above upper limit of normal (any type of troponin), Histopathologic confirmation of myocarditis, abnormal electrocardiogram (ECG or EKG) or rhythm monitoring findings consistent with myocarditis, abnormal cardiac function or wall motion abnormalities on echocardiogram, cMRI findings consistent with myocarditis, No other identifiable cause of the symptoms and findings. US researchers say teenagers are more likely to get vaccine-related myocarditis than end up in hospital with Covid Skip to main content Skip to navigation Print subscriptions Main outcomes and measures: : Myocarditis is an inflammation of the heart muscle. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination - JAMA Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. 2022 May 24;327(20):2019-2020. doi: 10.1001/jama.2022.5131. *** Rates of myocarditis and pericarditis were higher with the Moderna vaccine in both males and . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Lancet. Case Description and Clinical Course a. . Researchers added together cases after first and second doses to reach a total rate of 77 cases per million in this male age group triggered by vaccination, a sixth that seen after infection. CDC twenty four seven. Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases. 2022 Jun 1;5(6):e2218505. sharing sensitive information, make sure youre on a federal We take your privacy seriously. HHS Vulnerability Disclosure, Help Unauthorized use of these marks is strictly prohibited. Incidence Rates and Rate Ratios of Myocarditis in Vaccinated Individuals Compared With Control Groups. The study shows a low but significant rate of myocarditis among vaccine recipients, at less than 1 per 100,000 recipients. 3 0 obj xVMo8#Yi~*vSh6vm";Bk+;#{7BWAl)q7MgGSs]Hg>^Dx+2 2Mz49K-+i2\?')I!crVZ Pv)(v0Rv0`U4')>og)o|VA( CpN4yLc7zL''E->3`Vlk2dmUH'IS[X,sKWsQh &5ER(BBze?>M>#)V. Among individuals older than 40 years of age, there were no more than 8 reports of myocarditis for any individual age after receiving either vaccine. It affects fewer than 20 people per 1,000,000 COVID-19 vaccinations.3,5,7 Only the mRNA vaccines (Pfizer-BioNTech and Moderna) have been linked with myocarditis. For Moderna's vaccine, rates of myocarditis or pericarditis overall were 23 cases per million first doses and 62.5 cases per million second doses. A recent study classifying Long COVID into four types can help health care providers better target treatments for a patients specific symptoms. Information regarding the risk for myocarditis with mRNA COVID-19 vaccines should be disseminated to providers to share with vaccine recipients. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). NHLBI Information & Resources on COVID-19. In terms of. Those who have been diagnosed with myocarditis should consult with their cardiologist (heart doctor) about return to exercise or sports. CDC also encourages reporting of any additional clinically significant adverse event, even if it is not clear whether a vaccination caused the event. Though rare, Moderna Covid vaccine recipients have higher risk - CNBC The analysis assumed 95% vaccine effectiveness of 2 doses of a mRNA COVID-19 vaccine in preventing COVID-19 cases and hospitalization and assessed outcomes for a 120-day period. Moderna says Covid vaccine has fewer breakthrough cases than Pfizer's That means the vaccines protect heart health. They suggest the rates of myocarditis after the Moderna-NIAID vaccine may be two-and-a-half times higher. They also recover normal heart function sooner.12. Myocarditis typically causes shortness of breath and chest pain. The work group also reviewed a benefit-risk assessment of myocarditis events after receipt of mRNA COVID-19 vaccines, considering recent epidemiology of COVID-19 and sequelae of COVID-19, including myocarditis and multisystem inflammatory syndrome in children (MIS-C). FLEG: The CDC (Centers for Disease Control and Prevention) recommends COVID-19 vaccination for children as young as 6 months. A., & American Heart Association Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young and Stroke Council (2021). 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. They help us to know which pages are the most and least popular and see how visitors move around the site. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2external icon. Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. JEROME FLEG, M.D. Young Men's Myocarditis Risk 5 Times Higher With Moderna vs Pfizer Vax Autopsy cases may be classified as confirmed clinical myocarditis on the basis of meeting histopathologic criteria if no other identifiable cause. To meet the ECG or rhythm monitoring criterion, a probable case must include at least one of 1) ST-segment or T-wave abnormalities; 2) Paroxysmal or sustained atrial, supraventricular, or ventricular arrhythmias; or 3) AV nodal conduction delays or intraventricular conduction defects. Using either the original or the revised Lake Louise criteria. 2023 Jan 17;11(2):208. doi: 10.3390/vaccines11020208. *** The highest reporting rates were among males aged 1217 years and those aged 1824 years (62.8 and 50.5 reported myocarditis cases per million second doses of mRNA COVID-19 vaccine administered, respectively). Saving Lives, Protecting People, Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the, The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. July 5, 2022, U.S. Department of Health and Human Services, Benefits of COVID-19 vaccines outweigh a very small risk of heart complications, You can learn more about myocarditis symptoms, diagnosis, and treatment from the NHLBI, Countermeasures Injury Compensation Program, Researching COVID to Enhance Recovery (RECOVER), CONNECTS-Collaborative Cohort of Cohorts for COVID-19 Research (CONNECTS-C4R), https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total, https://doi.org/10.1161/CIR.0000000000001001, https://doi.org/10.1038/s41591-021-01630-0, https://doi.org/10.1016/j.hrtlng.2020.08.013, https://doi.org/10.1007/s12471-022-01677-9, https://doi.org/10.1016/j.vaccine.2020.12.046, https://doi.org/10.1016/j.ijcard.2022.01.037, https://doi.org/10.1007/s00392-022-02007-0, https://doi.org/10.1016/j.mayocpiqo.2021.12.006, https://doi.org/10.1177/01410768211052589, https://doi.org/10.1101/2021.10.05.21264581. It is unclear how many of these cases are a direct consequence of the vaccine versus coincidental. The walls of the heart become inflamed, which weakens the hearts pumping action and can cause irregular heart rhythms, heart failure, and other complications. According to the US Centers for Disease Control and Prevention, myocarditis/pericarditis rates are 12.6 cases per million doses of second-dose mRNA vaccine among individuals 12 to 39 years of age. This analysis did not include the potential benefit of preventing post-COVID-19 conditions, such as prolonged symptoms and MIS-C (6,7). Its clear that vaccination can protect you from myocarditis by protecting you from COVID-19 infection. Continued use of mRNA COVID-19 vaccines in all recommended age groups will prevent morbidity and mortality from COVID-19 that far exceed the number of cases of myocarditis expected. Q&A: COVID-19, Vaccines, and Myocarditis Americans received more than 590 million doses of COVID-19 vaccines between December 2020 and June 2022.1 The most intensive safety monitoring system in U.S. history has made it possible to detect even very rare COVID-19 vaccine side effects, including myocarditis, which is inflammation of the heart muscle. **** The risks were assessed as the number of myocarditis patients reported to VAERS that occurred within 7 days of receipt of a second dose of an mRNA COVID-19 vaccine per million second doses administered through the week of June 11, 2021. The benefit-risk assessment was stratified by age group and sex. Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. An analysis of 51 patients with possible or confirmed myocarditis showed that 70% were male, and the average age was 56. Follow-up is ongoing to identify and understand longer-term outcomes after myocarditis occurring after COVID-19 vaccination. You may have seen the recent reports linking rare cases. At that meeting, a chart showed that through early June, there was a higher rate of myocarditis among people who received Moderna than Pfizer-BioNTech about 20 per 1 million doses for. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. COVID-Vaccine Myocarditis: Rare, Mild, and Usually a Guy Thing - Medscape Reporting rates (per 1 million doses administered) of myocarditis among females after Moderna COVID-19 vaccination, days 0-7 after vaccination (through Jan 13, 2022 6 Moderna (Females) Ages (years) Dose 1 Dose 2 18-24 0.5 5.5 25-29 0.3 5.8 30-39 0.6 0.6 40-49 0.8 1.6 50-64 0.8 0.4 65+ 0.1 0.5 85,729,766 You can review and change the way we collect information below. Reports of Guillain-Barr Syndrome After COVID-19 Vaccination in the United States. Learn about the four phases of clinical research, what questions researchers try to answer in each, and how a vaccine is developed, approved, and manufactured.
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