Analysis set for each outcome and definition.
<div><p>Introduction</p><p>Neurologic or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus disease 2019 (COVID-19) vaccine safety surveillance. To contextualize United States (US) surveillance findings, it is important to quantify...
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2025
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| _version_ | 1849927640745508864 |
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| author | Shelby S. Fisher (22676406) |
| author2 | Arnstein Lindaas (22676409) Stella G. Muthuri (5395769) Patricia C. Lloyd (18453529) Joann F. Gruber (18453535) Morgan M. Richey (21253213) Hai Lyu (22676412) Angela S. Cheng (22676415) Lisa S. Kowarski (22676418) Mollie M. McKillop (9111996) Christine Bui (21253201) Tainya C. Clarke (12892921) Jeffrey Beers (22676421) Timothy Burrell (12892927) Pablo Freyria Duenas (22676424) Yangping Chen (16549866) Minya Sheng (22676427) Richard A. Forshee (18453553) Steven A. Anderson (11865398) Yoganand Chillarige (18453556) Mary S. Anthony (13922319) Azadeh Shoaibi (11060528) J. Bradley Layton (9756019) |
| author2_role | author author author author author author author author author author author author author author author author author author author author author author |
| author_facet | Shelby S. Fisher (22676406) Arnstein Lindaas (22676409) Stella G. Muthuri (5395769) Patricia C. Lloyd (18453529) Joann F. Gruber (18453535) Morgan M. Richey (21253213) Hai Lyu (22676412) Angela S. Cheng (22676415) Lisa S. Kowarski (22676418) Mollie M. McKillop (9111996) Christine Bui (21253201) Tainya C. Clarke (12892921) Jeffrey Beers (22676421) Timothy Burrell (12892927) Pablo Freyria Duenas (22676424) Yangping Chen (16549866) Minya Sheng (22676427) Richard A. Forshee (18453553) Steven A. Anderson (11865398) Yoganand Chillarige (18453556) Mary S. Anthony (13922319) Azadeh Shoaibi (11060528) J. Bradley Layton (9756019) |
| author_role | author |
| dc.creator.none.fl_str_mv | Shelby S. Fisher (22676406) Arnstein Lindaas (22676409) Stella G. Muthuri (5395769) Patricia C. Lloyd (18453529) Joann F. Gruber (18453535) Morgan M. Richey (21253213) Hai Lyu (22676412) Angela S. Cheng (22676415) Lisa S. Kowarski (22676418) Mollie M. McKillop (9111996) Christine Bui (21253201) Tainya C. Clarke (12892921) Jeffrey Beers (22676421) Timothy Burrell (12892927) Pablo Freyria Duenas (22676424) Yangping Chen (16549866) Minya Sheng (22676427) Richard A. Forshee (18453553) Steven A. Anderson (11865398) Yoganand Chillarige (18453556) Mary S. Anthony (13922319) Azadeh Shoaibi (11060528) J. Bradley Layton (9756019) |
| dc.date.none.fl_str_mv | 2025-11-24T18:40:22Z |
| dc.identifier.none.fl_str_mv | 10.1371/journal.pone.0333704.t001 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/dataset/Analysis_set_for_each_outcome_and_definition_/30698083 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Medicine Neuroscience Biotechnology Immunology Cancer Mental Health Infectious Diseases Environmental Sciences not elsewhere classified weighted hazard ratios still consistently elevated potential adverse events coronavirus disease 2019 contextualize united states 78 &# 8211 60 &# 8211 45 &# 8211 23 &# 8211 20 &# 8211 18 &# 8211 04 &# 8211 mediated adverse events vaccine safety surveillance postexposure reference windows 01 &# 8211 controlled risk interval mediated aes cannot aes included guillain xlink "> neurologic xlink "> covid xlink "> mediated conditions surveillance findings risk windows included adults 01 ). remaining aes transverse myelitis study period study observed service data relative incidences medicare fee matched comparators inverse probability increased risks increased risk generally modest data sources consistent evidence confidence intervals commercial database barré syndrome 28 ). |
| dc.title.none.fl_str_mv | Analysis set for each outcome and definition. |
| dc.type.none.fl_str_mv | Dataset info:eu-repo/semantics/publishedVersion dataset |
| description | <div><p>Introduction</p><p>Neurologic or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus disease 2019 (COVID-19) vaccine safety surveillance. To contextualize United States (US) surveillance findings, it is important to quantify the association of AEs with COVID-19 diagnoses among US adults before the introduction of COVID-19 vaccines.</p><p>Methods</p><p>Cohort and self-controlled risk interval (SCRI) designs were used in 2 US administrative claims data sources—Merative™ MarketScan<sup>®</sup> Commercial Database (ages 18−64 years) and Medicare fee-for-service data (ages ≥ 65 years). AEs included Guillain-Barré syndrome (GBS), Bell’s palsy, encephalitis/encephalomyelitis, narcolepsy, immune thrombocytopenia (ITP), and transverse myelitis. The cohort (study period, 1 April 2020−10 December 2020) included adults with COVID-19 diagnoses and matched comparators. Inverse probability of treatment-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated. The SCRI (study period, 1 June 2020−10 December 2020) identified the AEs in risk windows after COVID-19 diagnosis and pre- and postexposure reference windows. Relative incidences (RIs) and 95% CIs were estimated with seasonality-adjusted conditional Poisson regression models accounting for outcome-dependent observation windows.</p><p>Results</p><p>The study observed a consistent association between COVID-19 diagnosis and GBS: MarketScan HR = 9.57 (95% CI, 1.23–74.74), RI = 8.53 (95% CI, 2.45–29.7); Medicare HR = 1.97 (95% CI, 1.04–3.74), RI = 4.63 (95% CI, 1.78–12.01). For ITP, the association was weaker, but still consistently elevated: MarketScan HR = 2.06 (95% CI, 1.20–3.53), RI = 1.74 (95% CI, 1.01–3.00); Medicare HR = 1.36 (95% CI, 1.18–1.57), RI = 1.91 (95% CI, 1.60–2.28). For all remaining AEs, there was not consistent evidence of an association with COVID-19, with estimates that were generally modest, imprecise, or varying by study design.</p><p>Conclusions</p><p>COVID-19 diagnoses were associated with an increased risk of GBS and ITP in both data sources and study designs. Increased risks of other neurologic/immune-mediated AEs cannot be ruled out.</p></div> |
| eu_rights_str_mv | openAccess |
| id | Manara_b168b93cf3d009cb44fed5ed50e5ec89 |
| identifier_str_mv | 10.1371/journal.pone.0333704.t001 |
| network_acronym_str | Manara |
| network_name_str | ManaraRepo |
| oai_identifier_str | oai:figshare.com:article/30698083 |
| publishDate | 2025 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Analysis set for each outcome and definition.Shelby S. Fisher (22676406)Arnstein Lindaas (22676409)Stella G. Muthuri (5395769)Patricia C. Lloyd (18453529)Joann F. Gruber (18453535)Morgan M. Richey (21253213)Hai Lyu (22676412)Angela S. Cheng (22676415)Lisa S. Kowarski (22676418)Mollie M. McKillop (9111996)Christine Bui (21253201)Tainya C. Clarke (12892921)Jeffrey Beers (22676421)Timothy Burrell (12892927)Pablo Freyria Duenas (22676424)Yangping Chen (16549866)Minya Sheng (22676427)Richard A. Forshee (18453553)Steven A. Anderson (11865398)Yoganand Chillarige (18453556)Mary S. Anthony (13922319)Azadeh Shoaibi (11060528)J. Bradley Layton (9756019)MedicineNeuroscienceBiotechnologyImmunologyCancerMental HealthInfectious DiseasesEnvironmental Sciences not elsewhere classifiedweighted hazard ratiosstill consistently elevatedpotential adverse eventscoronavirus disease 2019contextualize united states78 &# 821160 &# 821145 &# 821123 &# 821120 &# 821118 &# 821104 &# 8211mediated adverse eventsvaccine safety surveillancepostexposure reference windows01 &# 8211controlled risk intervalmediated aes cannotaes included guillainxlink "> neurologicxlink "> covidxlink ">mediated conditionssurveillance findingsrisk windowsincluded adults01 ).remaining aestransverse myelitisstudy periodstudy observedservice datarelative incidencesmedicare feematched comparatorsinverse probabilityincreased risksincreased riskgenerally modestdata sourcesconsistent evidenceconfidence intervalscommercial databasebarré syndrome28 ).<div><p>Introduction</p><p>Neurologic or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus disease 2019 (COVID-19) vaccine safety surveillance. To contextualize United States (US) surveillance findings, it is important to quantify the association of AEs with COVID-19 diagnoses among US adults before the introduction of COVID-19 vaccines.</p><p>Methods</p><p>Cohort and self-controlled risk interval (SCRI) designs were used in 2 US administrative claims data sources—Merative™ MarketScan<sup>®</sup> Commercial Database (ages 18−64 years) and Medicare fee-for-service data (ages ≥ 65 years). AEs included Guillain-Barré syndrome (GBS), Bell’s palsy, encephalitis/encephalomyelitis, narcolepsy, immune thrombocytopenia (ITP), and transverse myelitis. The cohort (study period, 1 April 2020−10 December 2020) included adults with COVID-19 diagnoses and matched comparators. Inverse probability of treatment-weighted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated. The SCRI (study period, 1 June 2020−10 December 2020) identified the AEs in risk windows after COVID-19 diagnosis and pre- and postexposure reference windows. Relative incidences (RIs) and 95% CIs were estimated with seasonality-adjusted conditional Poisson regression models accounting for outcome-dependent observation windows.</p><p>Results</p><p>The study observed a consistent association between COVID-19 diagnosis and GBS: MarketScan HR = 9.57 (95% CI, 1.23–74.74), RI = 8.53 (95% CI, 2.45–29.7); Medicare HR = 1.97 (95% CI, 1.04–3.74), RI = 4.63 (95% CI, 1.78–12.01). For ITP, the association was weaker, but still consistently elevated: MarketScan HR = 2.06 (95% CI, 1.20–3.53), RI = 1.74 (95% CI, 1.01–3.00); Medicare HR = 1.36 (95% CI, 1.18–1.57), RI = 1.91 (95% CI, 1.60–2.28). For all remaining AEs, there was not consistent evidence of an association with COVID-19, with estimates that were generally modest, imprecise, or varying by study design.</p><p>Conclusions</p><p>COVID-19 diagnoses were associated with an increased risk of GBS and ITP in both data sources and study designs. Increased risks of other neurologic/immune-mediated AEs cannot be ruled out.</p></div>2025-11-24T18:40:22ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.1371/journal.pone.0333704.t001https://figshare.com/articles/dataset/Analysis_set_for_each_outcome_and_definition_/30698083CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/306980832025-11-24T18:40:22Z |
| spellingShingle | Analysis set for each outcome and definition. Shelby S. Fisher (22676406) Medicine Neuroscience Biotechnology Immunology Cancer Mental Health Infectious Diseases Environmental Sciences not elsewhere classified weighted hazard ratios still consistently elevated potential adverse events coronavirus disease 2019 contextualize united states 78 &# 8211 60 &# 8211 45 &# 8211 23 &# 8211 20 &# 8211 18 &# 8211 04 &# 8211 mediated adverse events vaccine safety surveillance postexposure reference windows 01 &# 8211 controlled risk interval mediated aes cannot aes included guillain xlink "> neurologic xlink "> covid xlink "> mediated conditions surveillance findings risk windows included adults 01 ). remaining aes transverse myelitis study period study observed service data relative incidences medicare fee matched comparators inverse probability increased risks increased risk generally modest data sources consistent evidence confidence intervals commercial database barré syndrome 28 ). |
| status_str | publishedVersion |
| title | Analysis set for each outcome and definition. |
| title_full | Analysis set for each outcome and definition. |
| title_fullStr | Analysis set for each outcome and definition. |
| title_full_unstemmed | Analysis set for each outcome and definition. |
| title_short | Analysis set for each outcome and definition. |
| title_sort | Analysis set for each outcome and definition. |
| topic | Medicine Neuroscience Biotechnology Immunology Cancer Mental Health Infectious Diseases Environmental Sciences not elsewhere classified weighted hazard ratios still consistently elevated potential adverse events coronavirus disease 2019 contextualize united states 78 &# 8211 60 &# 8211 45 &# 8211 23 &# 8211 20 &# 8211 18 &# 8211 04 &# 8211 mediated adverse events vaccine safety surveillance postexposure reference windows 01 &# 8211 controlled risk interval mediated aes cannot aes included guillain xlink "> neurologic xlink "> covid xlink "> mediated conditions surveillance findings risk windows included adults 01 ). remaining aes transverse myelitis study period study observed service data relative incidences medicare fee matched comparators inverse probability increased risks increased risk generally modest data sources consistent evidence confidence intervals commercial database barré syndrome 28 ). |