{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T05:10:31Z","timestamp":1788844231474,"version":"build-2803163510"},"reference-count":56,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T00:00:00Z","timestamp":1788825600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cell. Infect. Microbiol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is routinely recommended for adolescents, adults, and pregnant individuals. Ongoing post-marketing surveillance is critical to monitor its safety profile and detect rare or unexpected adverse events (AEs) following immunization. This study aims to comprehensively analyze Tdap-related AEs reported to the Vaccine Adverse Event Reporting System (VAERS) over the past decade, with a focus on safety profiles in specific subpopulations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We retrospectively analyzed US AE reports related to Tdap vaccination from VAERS for the period 2015 to May 2025. Data mining was conducted using four disproportionality algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinkage (MGPS). The False Discovery Rate (FDR) was controlled at 5% to minimize false positives. Subgroup analyses focused on adolescents (aged 10\u201318 years), older adults (aged \u226565 years), pregnant individuals, and sex-based subgroups (males vs. non-pregnant females). Time of onset was characterized using Weibull distribution analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 20,128 AE reports were identified, with 95.80% classified as non-serious. Injection site erythema, injection site swelling, and erythema were the most frequently reported positive signals. The majority of AEs (70.31%) occurred within one day of vaccination, showing an \u201cearly failure\u201d pattern in Weibull analysis. Tdap did not exhibit any disproportionate accumulation of unexpected AEs among older adults. Among 744 pregnancy-related reports, no new or unexpected safety signals related to maternal or fetal outcomes were detected. Notably, the adolescent subgroup showed a significant signal for opisthotonus (ROR\u00a0=\u00a08.55). In non-pregnant females, bursal fluid accumulation (ROR\u00a0=\u00a021.22) and radiculitis brachial (ROR\u00a0=\u00a014.42) were disproportionately elevated, whereas no such signals were found in males.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This 10-year surveillance study revealed no unexpected signals for Tdap in the overall population, older adults, males, or pregnant women. While most reports were non-serious, the signals of radiculitis brachial in non-pregnant females generate hypotheses that require formal testing in active surveillance systems. Our findings are generally consistent with the current Tdap vaccination recommendations and highlight the importance of ongoing post-marketing surveillance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcimb.2026.1831548","type":"journal-article","created":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T04:26:07Z","timestamp":1788841567000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Post-marketing safety surveillance of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine: a disproportionality analysis of the vaccine adverse event reporting system (2015\u20132025)"],"prefix":"10.3389","volume":"16","author":[{"given":"Wenyan","family":"Song","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Taizhou First People\u2019s Hospital","place":["Taizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongjun","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Taizhou First People\u2019s Hospital","place":["Taizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meiyan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Taizhou First People\u2019s Hospital","place":["Taizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenye","family":"Liang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Taizhou First People\u2019s Hospital","place":["Taizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,8]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"8049","DOI":"10.1016\/j.vaccine.2010.10.005","article-title":"Shoulder injury related to vaccine administration (SIRVA)","volume":"28","author":"Atanasoff","year":"2010","journal-title":"Vaccine"},{"key":"B2","doi-asserted-by":"publisher","first-page":"S45","DOI":"10.1542\/peds.2010-1722H","article-title":"The Vaccine Safety Datalink: A model for monitoring immunization safety","volume":"127","author":"Baggs","year":"2011","journal-title":"Pediatrics"},{"key":"B3","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1080\/02813432.2023.2191653","article-title":"Sex and gender differences in primary care help-seeking for common somatic symptoms: a longitudinal study","volume":"41","author":"Ballering","year":"2023","journal-title":"Scand. J. Prim. Health Care"},{"key":"B4","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s002280050466","article-title":"A Bayesian neural network method for adverse drug reaction signal generation","volume":"54","author":"Bate","year":"1998","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"B5","doi-asserted-by":"publisher","first-page":"1456","DOI":"10.1093\/cid\/ciw607","article-title":"Acute demyelinating events following vaccines: a case-centered analysis","volume":"63","author":"Baxter","year":"2016","journal-title":"Clin. Infect. Dis."},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1037\/e506922006-001","article-title":"Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"55","author":"Broder","year":"2006","journal-title":"MMWR Recomm. Rep. Morb. Mortal. Wkly. Rep. Recomm. Rep."},{"key":"B7","doi-asserted-by":"publisher","first-page":"591","DOI":"10.2165\/00002018-200427080-00010","article-title":"Using MedDRA: Implications for risk management","volume":"27","author":"Brown","year":"2004","journal-title":"Drug Saf."},{"key":"B8","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1001\/jama.299.21.2502","article-title":"Syncope after vaccination--United States, January 2005-July 2007","volume":"57","year":"2008","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"B9","first-page":"468","article-title":"Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older - Advisory Committee on Immunization Practices (ACIP), 2012","volume":"61","year":"2012","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"B10","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1001\/jama.308.10.968-a","article-title":"Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012","volume":"62","year":"2013","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"B11","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1210\/endrev\/bnac017","article-title":"Estrogen receptor signaling in the immune system","volume":"44","author":"Chakraborty","year":"2023","journal-title":"Endocr. Rev."},{"key":"B12","doi-asserted-by":"publisher","first-page":"508","DOI":"10.1097\/MOP.0000000000001486","article-title":"Resurgence of pertussis: Whopping the \u2018100-day cough.\u2019","volume":"37","author":"Christie","year":"2025","journal-title":"Curr. Opin. Pediatr."},{"key":"B13","doi-asserted-by":"publisher","first-page":"4417","DOI":"10.1016\/j.vaccine.2008.06.074","article-title":"Brachial plexus neuritis following HPV vaccination","volume":"26","author":"Debeer","year":"2008","journal-title":"Vaccine"},{"key":"B14","doi-asserted-by":"publisher","first-page":"S310","DOI":"10.1093\/infdis\/jiaa469","article-title":"Pertussis (Whooping cough)","volume":"224","author":"Decker","year":"2021","journal-title":"J. Infect. Dis."},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2023.1078736","article-title":"Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: a Dutch cohort study and review of the literature","volume":"14","author":"Duijster","year":"2023","journal-title":"Front. Immunol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1002\/pds.677","article-title":"Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"B17","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1007\/s40121-022-00731-8","article-title":"Investigating tetanus, diphtheria, acellular pertussis vaccination during pregnancy and risk of congenital anomalies","volume":"12","author":"Florea","year":"2023","journal-title":"Infect. Dis. Ther."},{"key":"B18","doi-asserted-by":"publisher","first-page":"3429","DOI":"10.1016\/j.vaccine.2023.04.043","article-title":"Tdap vaccination during pregnancy and risk of chorioamnionitis and related infant outcomes","volume":"41","author":"Greenberg","year":"2023","journal-title":"Vaccine"},{"key":"B19","doi-asserted-by":"publisher","first-page":"1476","DOI":"10.1016\/j.vaccine.2019.11.074","article-title":"Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged \u226565 years, Vaccine Adverse Event Reporting System (VAERS), United States, September 2010\u2013December 2018","volume":"38","author":"Haber","year":"2020","journal-title":"Vaccine"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2024.102556","article-title":"Safety and immunogenicity of a single dose of Tdap compared to Td in pregnant women in Mali and 3 its effect on infant immune responses: a single-centre, randomised, double-blind, active-controlled phase 2 study","volume":"71","author":"Haidara","year":"2024","journal-title":"eClinicalMedicine"},{"key":"B21","doi-asserted-by":"publisher","first-page":"599","DOI":"10.3928\/0090-4481-20040901-11","article-title":"The role of the Vaccine Adverse Event Reporting System (VAERS) in monitoring vaccine safety","volume":"33","author":"Iskander","year":"2004","journal-title":"Pediatr. Ann."},{"key":"B22","doi-asserted-by":"publisher","first-page":"839","DOI":"10.1302\/0301-620X.105B8.BJJ-2023-0435","article-title":"SIRVA: Shoulder injury related to vaccine administration","author":"Jenkins","year":"2023","journal-title":"Bone Jt. J."},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2024.2324547","article-title":"Understanding the impact of adult pertussis and current approaches to vaccination: a narrative review and expert panel recommendations","volume":"20","author":"Kardos","year":"2024","journal-title":"Hum. Vaccines Immunother."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1897","DOI":"10.1001\/jama.2014.14825","article-title":"Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes","volume":"312","author":"Kharbanda","year":"2014","journal-title":"JAMA"},{"key":"B25","doi-asserted-by":"publisher","first-page":"626","DOI":"10.1038\/nri.2016.90","article-title":"Sex differences in immune responses","volume":"16","author":"Klein","year":"2016","journal-title":"Nat. Rev. Immunol."},{"key":"B26","first-page":"1","article-title":"Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel","volume":"55","author":"Kretsinger","year":"2006","journal-title":"MMWR Recomm. Rep. Morb. Mortal. Wkly. Rep. Recomm. Rep."},{"key":"B27","doi-asserted-by":"publisher","first-page":"387","DOI":"10.1002\/pds.964","article-title":"Comparison of data mining methodologies using Japanese spontaneous reports","volume":"13","author":"Kubota","year":"2004","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"B28","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1038\/s41541-025-01279-7","article-title":"More than half of shoulder vaccinations may end up in the subacromial space","volume":"10","author":"Kutaish","year":"2025","journal-title":"NPJ Vaccines"},{"key":"B29","doi-asserted-by":"publisher","first-page":"1","DOI":"10.15585\/mmwr.rr6702a1","article-title":"Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"67","author":"Liang","year":"2018","journal-title":"MMWR Recomm. Rep."},{"key":"B30","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2026.1733777","article-title":"Diphtheria-tetanus-acellular pertussis vaccine safety in children under 7 years: a post-marketing analysis of the U.S. vaccine adverse event reporting system","volume":"16","author":"Liu","year":"2026","journal-title":"Front. Cell. Infect. Microbiol."},{"key":"B31","doi-asserted-by":"publisher","first-page":"e45040","DOI":"10.7759\/cureus.45040","article-title":"Brachial neuritis after a COVID-19 booster vaccination: a case report and literature review","volume":"15","author":"Loganathan","year":"2023","journal-title":"Cureus"},{"key":"B32","doi-asserted-by":"publisher","first-page":"289","DOI":"10.1080\/14760584.2018.1445530","article-title":"Controlling pertussis: how can we do it? A focus on immunization","volume":"17","author":"Martin\u00f3n-Torres","year":"2018","journal-title":"Expert Rev. Vaccines"},{"key":"B33","doi-asserted-by":"publisher","first-page":"560","DOI":"10.1097\/AOG.0000000000001888","article-title":"Safety of tetanus, diphtheria, and pertussis vaccination during pregnancy: a systematic review","volume":"129","author":"McMillan","year":"2017","journal-title":"Obstet. Gynecol."},{"key":"B34","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1007\/978-3-319-50512-1_8","article-title":"Acute brachial radiculitis (Parsonage-Turner syndrome)","volume-title":"Musculoskeletal Sports and Spine Disorders","author":"Mizrahi","year":"2017"},{"key":"B35","doi-asserted-by":"publisher","first-page":"2872","DOI":"10.1080\/21645515.2015.1072664","article-title":"The centers for disease control and prevention\u2019s public health response to monitoring Tdap safety in pregnant women in the United States","volume":"11","author":"Moro","year":"2015","journal-title":"Hum. Vaccines Immunother."},{"key":"B36","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2017-4171","article-title":"Safety surveillance of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines","volume":"142","author":"Moro","year":"2018","journal-title":"Pediatrics"},{"key":"B37","doi-asserted-by":"publisher","first-page":"50","DOI":"10.1016\/j.vaccine.2017.11.039","article-title":"Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990\u20132016","volume":"36","author":"Moro","year":"2018","journal-title":"Vaccine"},{"key":"B38","doi-asserted-by":"publisher","first-page":"S105","DOI":"10.1097\/INF.0000000000004607","article-title":"Vaccination during pregnancy in the Vaccine Safety Datalink 2002\u20132022","volume":"44","author":"Naleway","year":"2025","journal-title":"Pediatr. Infect. Dis. J."},{"key":"B39","doi-asserted-by":"publisher","first-page":"1086","DOI":"10.1097\/AOG.0000000000004166","article-title":"Evaluating the association of stillbirths after maternal vaccination in the Vaccine Safety Datalink","volume":"136","author":"Panagiotakopoulos","year":"2020","journal-title":"Obstet. Gynecol."},{"key":"B40","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2019.34.e105","article-title":"A 6-year prospective, observational, multi-center post-marketing surveillance of the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in Korea","volume":"34","author":"Park","year":"2019","journal-title":"J. Korean Med. Sci."},{"key":"B41","doi-asserted-by":"publisher","first-page":"6007","DOI":"10.1016\/j.vaccine.2018.08.022","article-title":"Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: a systematic review","volume":"36","author":"Patterson","year":"2018","journal-title":"Vaccine"},{"key":"B42","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1002\/pds.1001","article-title":"The reporting odds ratio and its advantages over the proportional reporting ratio","volume":"13","author":"Rothman","year":"2004","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"B43","doi-asserted-by":"publisher","first-page":"995","DOI":"10.1007\/s40264-013-0061-7","article-title":"Illustration of the Weibull shape parameter signal detection tool using electronic healthcare record data","volume":"36","author":"Sauzet","year":"2013","journal-title":"Drug Saf."},{"key":"B44","doi-asserted-by":"publisher","DOI":"10.1136\/bcr-2012-007673","article-title":"Acute brachial neuritis following influenza vaccination","volume":"2012","author":"Shaikh","year":"2012","journal-title":"BMJ Case Rep."},{"key":"B45","doi-asserted-by":"publisher","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":"Shimabukuro","year":"2015","journal-title":"Vaccine"},{"key":"B46","doi-asserted-by":"publisher","first-page":"2908","DOI":"10.1016\/S0264-410X(99)00132-2","article-title":"An overview of the Vaccine Adverse Event Reporting System (VAERS) as a surveillance system","volume":"17","author":"Singleton","year":"1999","journal-title":"Vaccine"},{"key":"B47","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1542\/peds.2015-1120","article-title":"Sources of infant pertussis infection in the United States","volume":"136","author":"Skoff","year":"2015","journal-title":"Pediatrics"},{"key":"B48","doi-asserted-by":"publisher","first-page":"1602","DOI":"10.1001\/jama.1994.03510440062034","article-title":"Adverse events associated with childhood vaccines other than pertussis and rubella: summary of a report from the Institute of Medicine","volume":"271","author":"Stratton","year":"1994","journal-title":"JAMA"},{"key":"B49","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1038\/nrneurol.2011.62","article-title":"Clinical and pathophysiological concepts of neuralgic amyotrophy","volume":"7","author":"Van Alfen","year":"2011","journal-title":"Nat. Rev. Neurol."},{"key":"B50","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0128361","article-title":"Incidence of neuralgic amyotrophy (Parsonage Turner syndrome) in a primary care setting - a prospective cohort study","volume":"10","author":"Van Alfen","year":"2015","journal-title":"PloS One"},{"key":"B51","doi-asserted-by":"publisher","first-page":"438","DOI":"10.1093\/brain\/awh722","article-title":"The clinical spectrum of neuralgic amyotrophy in 246 cases","volume":"129","author":"Van Alfen","year":"2006","journal-title":"Brain"},{"key":"B52","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1007\/s40121-025-01277-1","article-title":"Understanding the epidemiology and contributing factors of post-COVID-19 pertussis outbreaks: a narrative review","volume":"15","author":"Vargas-Zambrano","year":"2026","journal-title":"Infect. Dis. Ther."},{"key":"B53","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1002\/mus.25008","article-title":"Neuralgic amyotrophy: an update on diagnosis, pathophysiology, and treatment","volume":"53","author":"Van Eijk","year":"2016","journal-title":"Muscle Nerve"},{"key":"B54","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1097\/00006454-200404000-00002","article-title":"Understanding vaccine safety information from the Vaccine Adverse Event Reporting System","volume":"23","author":"Varricchio","year":"2004","journal-title":"Pediatr. Infect. Dis. J."},{"key":"B55","doi-asserted-by":"publisher","first-page":"136","DOI":"10.1186\/s12879-020-4824-3","article-title":"Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review","volume":"20","author":"Vygen-Bonnet","year":"2020","journal-title":"BMC Infect. Dis."},{"key":"B56","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2025.1609409","article-title":"Real-world pharmacovigilance reports of hepatitis A inactivated and hepatitis B (recombinant) vaccine: insights from disproportionality analysis of the vaccine adverse event reporting system","volume":"15","author":"Zhou","year":"2025","journal-title":"Front. Cell. Infect. Microbiol."}],"container-title":["Frontiers in Cellular and Infection Microbiology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcimb.2026.1831548\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T04:26:09Z","timestamp":1788841569000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcimb.2026.1831548\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,8]]},"references-count":56,"alternative-id":["10.3389\/fcimb.2026.1831548"],"URL":"https:\/\/doi.org\/10.3389\/fcimb.2026.1831548","relation":{},"ISSN":["2235-2988"],"issn-type":[{"value":"2235-2988","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,8]]},"article-number":"1831548"}}