Pub Date : 2023-10-01DOI: 10.1177/00694770231204935
A national cross-sectional study evaluated the incidence and characteristics of adverse drug events by sex using adverse drug event data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) and drug use data from the Medical Expenditure Panel Survey (MEPS). Approximately 20 million adverse events were identified in the FAERS database, of which 63.3% (12.6 million) were documented in women. The median number of adverse event reports in females was 45.1% higher than those in men. When adjusted by drug use, women had a median number of adverse events 15% higher than men. Based on the results of this national cross-sectional study
{"title":"Reporting on Adverse Clinical Events","authors":"","doi":"10.1177/00694770231204935","DOIUrl":"https://doi.org/10.1177/00694770231204935","url":null,"abstract":"A national cross-sectional study evaluated the incidence and characteristics of adverse drug events by sex using adverse drug event data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) and drug use data from the Medical Expenditure Panel Survey (MEPS). Approximately 20 million adverse events were identified in the FAERS database, of which 63.3% (12.6 million) were documented in women. The median number of adverse event reports in females was 45.1% higher than those in men. When adjusted by drug use, women had a median number of adverse events 15% higher than men. Based on the results of this national cross-sectional study","PeriodicalId":500289,"journal":{"name":"Clin-Alert","volume":"132 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135707896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.1177/00694770231216043
A retrospective pharmacovigilance study evaluated cases of vestibular disorders following COVID (BNT162b2) vaccination using data from reports to the pharmacovigilance center of Georges-Pompidou European Hospital (France), in 2021. A total of 6608 adverse event cases were reported, of which 34 were classified as vestibular disorders associated with COVID vaccine administration. The majority (n = 19; 56%) of cases were reported by cases and the remainder by health care professionals (n = 15). The reports were predominantly in females (79%) and had a mean age of 54 years. The tine of onset from administration to onset of vestibular symptoms ranged from 1 hour to 90 days, with approximately one-third (32%) occurring within 24 hours. Half (50%) of the cases occurred between 1 and 7 days. Approximately one-fifth (18%) occurred between 1 and 7 days. More than half (62%) of the events occurred after the first dose and 32% were considered serious. Mean duration of symptoms was 8 days (range, 1-21 days). Complete resolution occurred in 13 cases (38%). The most commonly reported symptoms included vertigo, balance disorders, nystagmus, tinnitus, and hearing loss. The estimated regional reporting rate for vestibular disorders was 26 [95% CI: 17-34] cases/1 million persons vaccinated. Based on the results of this retrospective study, the authors concluded that the causal relationship between COVID vaccination and vestibular disorders cannot be fully established. They also recommended that clinicians should be aware of this potentially rare adverse effect.
{"title":"Reporting on Adverse Clinical Events","authors":"","doi":"10.1177/00694770231216043","DOIUrl":"https://doi.org/10.1177/00694770231216043","url":null,"abstract":"A retrospective pharmacovigilance study evaluated cases of vestibular disorders following COVID (BNT162b2) vaccination using data from reports to the pharmacovigilance center of Georges-Pompidou European Hospital (France), in 2021. A total of 6608 adverse event cases were reported, of which 34 were classified as vestibular disorders associated with COVID vaccine administration. The majority (n = 19; 56%) of cases were reported by cases and the remainder by health care professionals (n = 15). The reports were predominantly in females (79%) and had a mean age of 54 years. The tine of onset from administration to onset of vestibular symptoms ranged from 1 hour to 90 days, with approximately one-third (32%) occurring within 24 hours. Half (50%) of the cases occurred between 1 and 7 days. Approximately one-fifth (18%) occurred between 1 and 7 days. More than half (62%) of the events occurred after the first dose and 32% were considered serious. Mean duration of symptoms was 8 days (range, 1-21 days). Complete resolution occurred in 13 cases (38%). The most commonly reported symptoms included vertigo, balance disorders, nystagmus, tinnitus, and hearing loss. The estimated regional reporting rate for vestibular disorders was 26 [95% CI: 17-34] cases/1 million persons vaccinated. Based on the results of this retrospective study, the authors concluded that the causal relationship between COVID vaccination and vestibular disorders cannot be fully established. They also recommended that clinicians should be aware of this potentially rare adverse effect.","PeriodicalId":500289,"journal":{"name":"Clin-Alert","volume":"202 ","pages":"1 - 24"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139026643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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