{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["20(11)"],"submitter":["Fisher SS"],"pubmed_abstract":["<h4>Introduction</h4>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.<h4>Methods</h4>Cohort and self-controlled risk interval (SCRI) designs were used in 2 US administrative claims data sources-Merative™ MarketScan® 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.<h4>Results</h4>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.<h4>Conclusions</h4>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."],"journal":["PloS one"],"pagination":["e0333704"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12643290"],"repository":["biostudies-literature"],"pubmed_title":["Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States."],"pmcid":["PMC12643290"],"pubmed_authors":["Anthony MS","Bui C","Fisher SS","Lindaas A","Lloyd PC","Clarke TC","Anderson SA","Duenas PF","Kowarski LS","Chillarige Y","Muthuri SG","Gruber JF","Shoaibi A","Cheng AS","Beers J","Sheng M","Lyu H","Burrell T","Forshee RA","Chen Y","Layton JB","Richey MM","McKillop MM"],"additional_accession":[]},"is_claimable":false,"name":"Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States.","description":"<h4>Introduction</h4>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.<h4>Methods</h4>Cohort and self-controlled risk interval (SCRI) designs were used in 2 US administrative claims data sources-Merative™ MarketScan® 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.<h4>Results</h4>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.<h4>Conclusions</h4>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.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025","modification":"2026-06-05T16:54:25.899Z","creation":"2026-06-05T03:06:34.11Z"},"accession":"S-EPMC12643290","cross_references":{"pubmed":["41284649"],"doi":["10.1371/journal.pone.0333704"]}}