Silvia Pérez-Vilar
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View article: Identifying COVID-19 disease severity in real-world data: Implications for medical product effectiveness studies
Identifying COVID-19 disease severity in real-world data: Implications for medical product effectiveness studies Open
View article: Trends in Medical Encounters Involving Cannabis-Related Disorders Among US Medicare Beneficiaries, 2017–2022
Trends in Medical Encounters Involving Cannabis-Related Disorders Among US Medicare Beneficiaries, 2017–2022 Open
Objectives. To characterize cannabis-related disorder medical encounter trends in the US Medicare population during 2017 to 2022. Methods. We conducted a descriptive study, which included 56 624 432 beneficiaries aged 65 years or older and…
View article: State Cannabis Legalization and Trends in Cannabis-Related Disorders in US Older Adults, 2017 to 2022
State Cannabis Legalization and Trends in Cannabis-Related Disorders in US Older Adults, 2017 to 2022 Open
This cross-sectional study examines trends in health care encounters with cannabis-related disorders among Medicare beneficiaries from 2017 to 2022.
View article: Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States
Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States Open
There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.
View article: A Descriptive Cohort Study of Drug Utilization Patterns Among Patients Hospitalized With Coronavirus Disease 2019 in the United States, January 2021–February 2022
A Descriptive Cohort Study of Drug Utilization Patterns Among Patients Hospitalized With Coronavirus Disease 2019 in the United States, January 2021–February 2022 Open
Background There is a dearth of drug utilization studies for coronavirus disease 2019 (COVID-19) treatments in 2021 and beyond after the introduction of vaccines and updated guidelines; such studies are needed to contextualize ongoing COVI…
View article: Risk of admission to hospital with arterial or venous thromboembolism among patients diagnosed in the ambulatory setting with covid-19 compared with influenza: retrospective cohort study
Risk of admission to hospital with arterial or venous thromboembolism among patients diagnosed in the ambulatory setting with covid-19 compared with influenza: retrospective cohort study Open
Objective To measure the 90 day risk of arterial thromboembolism and venous thromboembolism among patients diagnosed with covid-19 in the ambulatory (ie, outpatient, emergency department, or institutional) setting during periods before and…
View article: Cannabidiol exposures in the United States, National Poison Data System, July 2014–June 2021
Cannabidiol exposures in the United States, National Poison Data System, July 2014–June 2021 Open
This case series identified an increasing trend in CBD exposure cases managed by AAPCC. It showed serious medical outcomes in temporal association with exposure to non-FDA approved CBD products. Our findings also suggest both unintentional…
View article: Association of COVID-19 vs Influenza With Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Association of COVID-19 vs Influenza With Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients Open
Importance The incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear. Objective To measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized …
View article: Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 Open
This study uses 2 large US health care claims databases (Medicare fee-for-service and the US Food and Drug Administration’s Sentinel System) to examine systemic corticosteroid use among nonhospitalized patients with COVID-19.
View article: Systematic review of risk of SARS-CoV-2 infection and severity of COVID-19 with therapies approved to treat multiple sclerosis
Systematic review of risk of SARS-CoV-2 infection and severity of COVID-19 with therapies approved to treat multiple sclerosis Open
View article: Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015–2018
Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015–2018 Open
View article: Adverse events reported to the U.S. Food and Drug Administration Adverse Event Reporting System for tisagenlecleucel
Adverse events reported to the U.S. Food and Drug Administration Adverse Event Reporting System for tisagenlecleucel Open
The U.S. Food and Drug Administration (FDA) approved the first chimeric antigen receptor T‐cell therapy, tisagenlecleucel, in August 2017. We sought to describe adverse events (AEs) reported to the FDA Adverse Event Reporting System (FAERS…
View article: Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014–2018
Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014–2018 Open
Background In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States. It is approved for use in individuals aged 10–25 years. Our objective was to evaluate the safety of MenB…
View article: Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season
Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season Open
Background The Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of Guillain-Barré syndrome (GBS) in days 1–42 after 2018–2019 high-dose influenza vaccine (IIV3-HD) administration. We evaluated the signal …
View article: Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999–2017
Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999–2017 Open
View article: Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System
Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System Open
View article: Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017
Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017 Open
Reported adverse events were generally consistent with the safety experience observed in prelicensure studies and described in the sipuleucel-T package insert. Off-label use among overtly symptomatic men with CRPC, reporting bias, or lack …
View article: Surveillance for Guillain-Barré syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017–2018 season
Surveillance for Guillain-Barré syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017–2018 season Open
View article: Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study Open
Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as sign…
View article: Vaccine safety surveillance in pregnancy in low- and middle-income countries using GAIA case definitions: A feasibility assessment
Vaccine safety surveillance in pregnancy in low- and middle-income countries using GAIA case definitions: A feasibility assessment Open
GAIA case definitions for four neonatal outcomes and maternal vaccination were successfully piloted in 24 sentinel sites across four WHO regions. Our assessment found that modification of the stillbirth definition could help avoid potentia…
View article: Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines – Multi-country assessment
Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines – Multi-country assessment Open
View article: Bias due to differential and non-differential disease- and exposure misclassification in studies of vaccine effectiveness
Bias due to differential and non-differential disease- and exposure misclassification in studies of vaccine effectiveness Open
Misclassification can lead to significant bias in VE estimates and its impact strongly depends on the scenario. We developed a web-application for assessing the potential (joint) impact of possibly differential disease- and exposure miscla…
View article: Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines
Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines Open
OBJECTIVE: To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance s…
View article: Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination
Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination Open
View article: Progress in vaccination towards hepatitis B control and elimination in the Region of the Americas
Progress in vaccination towards hepatitis B control and elimination in the Region of the Americas Open
The achievements of vaccination programs in the Americas suggest that the elimination of perinatal and early childhood HB transmission could be feasible in the short-term. Moreover, the data gathered indicate that the Region may have alrea…
View article: Long-term impact of self-financed rotavirus vaccines on rotavirus-associated hospitalizations and costs in the Valencia Region, Spain
Long-term impact of self-financed rotavirus vaccines on rotavirus-associated hospitalizations and costs in the Valencia Region, Spain Open
View article: The Risk of Narcolepsy Following Receipt of Adjuvanted Pandemic 2009 The Subtype of Influenza A Virus (H1N1) Vaccines: Results of the SOMNIA Global Collaborative Study
The Risk of Narcolepsy Following Receipt of Adjuvanted Pandemic 2009 The Subtype of Influenza A Virus (H1N1) Vaccines: Results of the SOMNIA Global Collaborative Study Open
View article: Intussusception following rotavirus vaccination in the Valencia Region, Spain
Intussusception following rotavirus vaccination in the Valencia Region, Spain Open
Studies have shown high intussusception rates in Spain. We performed a hospital-based retrospective observational study of the intussusception risk following rotavirus vaccinations among infants in Valencia, a region of Spain with an annua…
View article: Effectiveness of rotavirus vaccines, licensed but not funded, against rotavirus hospitalizations in the Valencia Region, Spain
Effectiveness of rotavirus vaccines, licensed but not funded, against rotavirus hospitalizations in the Valencia Region, Spain Open
Both rotavirus vaccines were over 85% effective against rotavirus hospitalization among young children. The high effectiveness shown argues in favor of their inclusion in the official schedule. Additional information on rotavirus vaccine s…