{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T03:01:24Z","timestamp":1767841284145,"version":"3.49.0"},"reference-count":14,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T00:00:00Z","timestamp":1676592000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>Vaccine development against COVID-19 has mitigated severe disease. However, reports of rare but serious adverse events following immunization (sAEFI) in the young populations are fuelling parental anxiety and vaccine hesitancy. With a very early season of viral illnesses including COVID-19, respiratory syncytial virus (RSV), influenza, metapneumovirus and several others, children are facing a winter with significant respiratory illness burdens. Yet, COVID-19 vaccine and booster uptake remain sluggish due to the mistaken beliefs that children have low rates of severe COVID-19 illness as well as rare but severe complications from COVID-19 vaccine are common. In this study we examined composite sAEFI reported in association with COVID-19 vaccines in the United States (US) amongst 5-17-year-old children, to ascertain the composite reported risk associated with vaccination. Between December 13, 2020, and April 13, 2022, a total of 467,890,599 COVID-19 vaccine doses were administered to individuals aged 5\u201365 years in the US, of which 180 million people received at least 2 doses. In association with these, a total of 177,679 AEFI were reported to the Vaccine Adverse Event reporting System (VAERS) of which 31,797 (17.9%) were serious. The rates of ED visits per 100,000 recipients were 2.56 (95% CI: 2.70\u20133.47) amongst 5-11-year-olds, 18.25 (17.57\u201318.95) amongst 12-17-year-olds and 33.74 (33.36\u201334.13) amongst 18-65-year olds; hospitalizations were 1.07 (95% CI 0.87\u20131.32) per 100,000 in 5-11-year-olds, 6.83 (6.42\u20137.26) in 12-17-year olds and 8.15 (7.96\u20138.35) in 18\u201365 years; life-threatening events were 0.14 (95% CI: 0.08\u20130.25) per 100,000 in 5-11-year olds, 1.22 (1.05\u20131.41) in 12-17-year-olds and 2.96 (2.85\u20133.08) in 18\u201365 year olds; and death 0.03 (95% CI 0.01\u20130.10) per 100,000 in 5\u201311 year olds, 0.08 (0.05\u20130.14) amongst 12-17-year olds and 0.76 (0.71\u20130.82) in 18\u201365 years age group. The results of our study from national population surveillance data demonstrate rates of reported serious AEFIs amongst 5\u201317-year-olds which appear to be significantly lower than in 18-65-year-olds. These low risks must be taken into account in overall recommendation of COVID-19 vaccination amongst children.<\/jats:p>","DOI":"10.1371\/journal.pone.0281993","type":"journal-article","created":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T18:37:32Z","timestamp":1676659052000},"page":"e0281993","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["Reported rates of all-cause serious adverse events following immunization with BNT-162b in 5\u201317-year-old children in the United States"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3426-2001","authenticated-orcid":true,"given":"Halinder S.","family":"Mangat","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brady","family":"Rippon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6479-8910","authenticated-orcid":true,"given":"Nikita T.","family":"Reddy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akheel A.","family":"Syed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joel M.","family":"Maruthanal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanne","family":"Luedtke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jyothy J.","family":"Puthumana","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhinash","family":"Srivatsa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arnold","family":"Bosman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patty","family":"Kostkova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,2,17]]},"reference":[{"issue":"22","key":"pone.0281993.ref001","doi-asserted-by":"crossref","first-page":"2242","DOI":"10.1001\/jama.2022.7319","article-title":"Risk of Infection and Hospitalization Among Vaccinated and Unvaccinated Children and Adolescents in New York After the Emergence of the Omicron Variant","volume":"327","author":"V Dorabawila","year":"2022","journal-title":"JAMA"},{"issue":"6570","key":"pone.0281993.ref002","doi-asserted-by":"crossref","first-page":"913","DOI":"10.1126\/science.abn2566","article-title":"COVID-19 vaccines for children","volume":"374","author":"JS Gerber","year":"2021","journal-title":"Science"},{"issue":"20","key":"pone.0281993.ref003","doi-asserted-by":"crossref","first-page":"1951","DOI":"10.1001\/jama.2022.8061","article-title":"Cardiac Complications More Common After COVID-19 Than Vaccination","volume":"327","author":"BM Kuehn","year":"2022","journal-title":"JAMA"},{"key":"pone.0281993.ref004","unstructured":"Vaccine Adverse Event Reporting System: VAERS Data [Internet]. Health and Human Services. 2022 [cited 15 January, 2022]. https:\/\/vaers.hhs.gov\/data.html."},{"issue":"24","key":"pone.0281993.ref005","doi-asserted-by":"crossref","first-page":"2673","DOI":"10.1016\/j.vaccine.2013.04.009","article-title":"Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?","volume":"31","author":"MM McNeil","year":"2013","journal-title":"Vaccine"},{"key":"pone.0281993.ref006","doi-asserted-by":"crossref","first-page":"972464","DOI":"10.3389\/fpubh.2022.972464","article-title":"Analyses of reported severe adverse events after immunization with SARS-CoV-2 vaccines in the United States: One year on","volume":"10","author":"HS Mangat","year":"2022","journal-title":"Front Public Health"},{"key":"pone.0281993.ref007","unstructured":"COVID-19 Vaccination Demographics in the United States, National [Internet]. Center for Disease Control and Prevention. 2022 [cited 15 January, 2022]. https:\/\/data.cdc.gov\/Vaccinations\/COVID-19-Vaccination-Demographics-in-the-United-St\/km4m-vcsb\/data."},{"key":"pone.0281993.ref008","unstructured":"COVID-19 Vaccinations in the United States, Jurisdiction [Internet]. 2022 [cited 15 January, 2022]. https:\/\/data.cdc.gov\/Vaccinations\/COVID-19-Vaccinations-in-the-United-States-Jurisdi\/unsk-b7fc."},{"issue":"36","key":"pone.0281993.ref009","doi-asserted-by":"crossref","first-page":"4398","DOI":"10.1016\/j.vaccine.2015.07.035","article-title":"Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)","volume":"33","author":"TT Shimabukuro","year":"2015","journal-title":"Vaccine"},{"issue":"4","key":"pone.0281993.ref010","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1001\/jama.2021.24110","article-title":"Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021","volume":"327","author":"ME Oster","year":"2022","journal-title":"JAMA"},{"issue":"8","key":"pone.0281993.ref011","doi-asserted-by":"crossref","first-page":"e2227437","DOI":"10.1001\/jamanetworkopen.2022.27437","article-title":"COVID-19 Vaccination Intentions, Concerns, and Facilitators Among US Parents of Children Ages 6 Months Through 4 Years","volume":"5","author":"AM Scherer","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"7","key":"pone.0281993.ref012","doi-asserted-by":"crossref","first-page":"e2223253","DOI":"10.1001\/jamanetworkopen.2022.23253","article-title":"Post-COVID-19 Conditions Among Children 90 Days After SARS-CoV-2 Infection","volume":"5","author":"AL Funk","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"8","key":"pone.0281993.ref013","doi-asserted-by":"crossref","first-page":"e2225162","DOI":"10.1001\/jamanetworkopen.2022.25162","article-title":"Effectiveness Associated With BNT162b2 Vaccine Against Emergency Department and Urgent Care Encounters for Delta and Omicron SARS-CoV-2 Infection Among Adolescents Aged 12 to 17 Years","volume":"5","author":"SY Tartof","year":"2022","journal-title":"JAMA Netw Open"},{"issue":"6","key":"pone.0281993.ref014","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1056\/NEJMoa2203209","article-title":"Effectiveness of BNT162b2 Vaccine against Omicron in Children 5 to 11 Years of Age","volume":"387","author":"SHX Tan","year":"2022","journal-title":"The New England journal of medicine"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0281993","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T18:37:52Z","timestamp":1676659072000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0281993"}},"subtitle":[],"editor":[{"given":"Marwa Shawky","family":"Abdou","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,2,17]]},"references-count":14,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2023,2,17]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0281993","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,17]]}}}