{"title":"Adverse events affecting recovery from seasonal influenza vaccination in the hypertensive population: A population-based pharmacovigilance analysis","authors":"Hao Wu, Xiaona He, Yu Cao, Wei Gao","doi":"10.1101/2024.09.03.24313030","DOIUrl":null,"url":null,"abstract":"Seasonal influenza vaccination is crucial for preventing influenza and its complications. Data from the U.S. Vaccine Adverse Event Reporting System (VAERS) indicate a higher proportion of adverse events (AEs) after influenza vaccination in hypertensive people. However, there is limited evidence on AEs in hypertensive people following seasonal influenza vaccination. We collected a total of 4647 individuals on seasonal influenza vaccination and 6380 AEs from VAERS for hypertensive people aged 18 years or older from 1 January 2013 to 23 June 2023. We conducted propensity score matching (PSM) by adjusting for the demographic characteristics of the seasonal influenza-vaccinated hypertensive population and the season of onset. Cox regression analysis was used to calculate the risk ratio of reported adverse events (AEs) that affected recovery after seasonal influenza vaccination. Most AEs were nonserious and occurred within 48 hours. The most common AEs were general disorders and administration site conditions (therapeutic and non-therapeutic responses, inflammation) and musculoskeletal and connective tissue disorders (musculoskeletal and connective tissue pain and discomfort, bursal disorders, joint-related signs, and symptoms). All three types of seasonal influenza vaccines were associated with injection site reactions (47.07% trivalent influenza vaccine [TIA], hazard ratio, HR 2.04, 95% confidence interval, CI 1.22–3.40; 20.00% quadrivalent influenza vaccine [QIA], HR 2.81, 95% CI, 1.81–4.37; 67.48% influenza vaccine, unknown manufacturer [FLUX], HR 2.83, 95% CI, 1.12–7.15) and were the AEs affecting the largest proportion of delayed recoveries in the hypertensive population. Potential AEs following seasonal influenza vaccination may affect the recovery of the hypertensive population. The majority of AEs reported were general disorders, predominantly injection site reactions, and nonserious.","PeriodicalId":501071,"journal":{"name":"medRxiv - Epidemiology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"medRxiv - Epidemiology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2024.09.03.24313030","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
Seasonal influenza vaccination is crucial for preventing influenza and its complications. Data from the U.S. Vaccine Adverse Event Reporting System (VAERS) indicate a higher proportion of adverse events (AEs) after influenza vaccination in hypertensive people. However, there is limited evidence on AEs in hypertensive people following seasonal influenza vaccination. We collected a total of 4647 individuals on seasonal influenza vaccination and 6380 AEs from VAERS for hypertensive people aged 18 years or older from 1 January 2013 to 23 June 2023. We conducted propensity score matching (PSM) by adjusting for the demographic characteristics of the seasonal influenza-vaccinated hypertensive population and the season of onset. Cox regression analysis was used to calculate the risk ratio of reported adverse events (AEs) that affected recovery after seasonal influenza vaccination. Most AEs were nonserious and occurred within 48 hours. The most common AEs were general disorders and administration site conditions (therapeutic and non-therapeutic responses, inflammation) and musculoskeletal and connective tissue disorders (musculoskeletal and connective tissue pain and discomfort, bursal disorders, joint-related signs, and symptoms). All three types of seasonal influenza vaccines were associated with injection site reactions (47.07% trivalent influenza vaccine [TIA], hazard ratio, HR 2.04, 95% confidence interval, CI 1.22–3.40; 20.00% quadrivalent influenza vaccine [QIA], HR 2.81, 95% CI, 1.81–4.37; 67.48% influenza vaccine, unknown manufacturer [FLUX], HR 2.83, 95% CI, 1.12–7.15) and were the AEs affecting the largest proportion of delayed recoveries in the hypertensive population. Potential AEs following seasonal influenza vaccination may affect the recovery of the hypertensive population. The majority of AEs reported were general disorders, predominantly injection site reactions, and nonserious.