• MAUDE Adverse Event Report: DEKA / EL. (fda.gov)
  • Although HPV vaccines have not been linked to causing adverse pregnancy outcomes or side effects (adverse events) to the developing fetus among pregnant people vaccinated inadvertently, HPV vaccines have not been studied in pregnant people in clinical trials. (cdc.gov)
  • Data could not be pooled owing to heterogeneity in delta-9-tetrahydrocannabinol potency by dried weight, differing frequency and duration of treatment, and variability in assessing outcomes. (cfp.ca)
  • 13 - 15 Our own research in this area has built upon extensive work in aviation by developing a scale to evaluate the behaviour of the operating team in relation to other intraoperative events, processes and outcomes. (bmj.com)
  • Other possible adverse outcomes include spontaneous abortions (both early and late), major and minor birth defects, perinatal death, low birth weight, altered sex ratio, developmental or behavioral disabilities, and transplacental exposure to carcinogen (9-11). (cdc.gov)
  • Estimates of the prevalence of adverse reproductive outcomes indicate that these events occur with considerable frequency in the U.S. population. (cdc.gov)
  • The causes of most of these adverse outcomes are unknown. (cdc.gov)
  • Studies of adverse outcomes of pregnancy, however, are subject to several methodologic limitations. (cdc.gov)
  • For example, the detection of rare outcomes, such as birth defects, requires the study of several thousand pregnancies, and retrospective studies are subject to problems of recall and misclassification, both of reproductive events and of exposures (20,21). (cdc.gov)
  • The number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event, or as evidence about the existence, severity, frequency, or rates of problems associated with vaccines. (cdc.gov)
  • Prevalence, nature, severity and preventability of adverse drug events in mental health settings: findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) study. (ahrq.gov)
  • The warming of the planet will be gradual, but the increasing frequency and severity of extreme weather events, such as intense storms, heat waves, droughts and floods, will be abrupt and the consequences will be acutely felt. (who.int)
  • Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients. (ersjournals.com)
  • It is not distinguished by grouping frequency of migraine attacks, whether it is associated with severity scores of depression and anxiety, and with or without aura compared to controlled subjects. (medscape.com)
  • In the present study, we tested the hypothesis that migraine frequency may be predictive of depression/anxiety severity, regardless of the presence of auras. (medscape.com)
  • Specifically, we evaluated the relationship between severity of depression/anxiety and migraine frequency while controlling for potentially confounding factors (eg, sleep quality, employment, education, smoking status, and alcohol and coffee consumption). (medscape.com)
  • Below is the selection of side effect reports (a.k.a. adverse event reports) related to Eligard (Leuprolide) where reactions include prostatic specific antigen increased. (druglib.com)
  • However, users are generally unaware of the many potential adverse reactions that could have long-term effects, some of which are quite serious," said Higgins. (acsm.org)
  • Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported. (drugs.com)
  • The incidence of adverse reactions associated with ADVAIR DISKUS in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 2). (medicinenet.com)
  • This chapter is intended as a guide for the assessment and initial management of vaccine recipients who develop acute adverse reactions in a community setting (e.g., schools, public health clinics, health centres). (canada.ca)
  • In previous estimates in the United States, 3 to 7% of all hospitalizations were due to adverse drug reactions. (msdmanuals.com)
  • Carbamazepine (CBZ) is a commonly used drug for epilepsy that is associated with troublesome adverse events including dizziness, double vision, drowsiness, poor co-ordination and unsteadiness. (cochrane.org)
  • VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of U.S. licensed vaccines. (cdc.gov)
  • VAERS accepts reports of adverse events that occur following vaccination. (cdc.gov)
  • These adverse events often occur during peaks in drug plasma concentration. (cochrane.org)
  • Retinal arterial occlusive events caused by cholesterol, fibrinoplatelet or calcific emboli are known to occur in individuals with atheromatous vessels and aortic valves especially during or after interventional procedures such as cardiac catheterisation and coronary artery bypass graft procedures. (bmj.com)
  • Within hospitals, the operating theatre is reportedly the most common site for adverse events to occur, 1 probably because it represents a complex environment where technology, competence and resources require coordination under time pressure. (bmj.com)
  • Fainting itself has no adverse consequence but during a fall, severe head injuries could occur. (canada.ca)
  • Adverse events usually occur within the first few days following injection and are transient, but may persist for several months or, rarely, longer. (acnr.co.uk)
  • The prevalence of adverse events in admissions was 12.2% (95% CI 9.5% to 15.5%), with an incidence of 10.3 events per 100 admissions (95% CI 7.5 to 13.1). (bmj.com)
  • The incidence and nature of in-hospital adverse events: a systematic review. (ahrq.gov)
  • Greater frequency and intensity of heat waves will increase mortality and the incidence of heat stress and heat stroke. (who.int)
  • Other symptoms such as headache, palpitations and lower extremity oedema at the travel destination were reported with similar frequency in both groups. (bmj.com)
  • The association of depression and anxiety with headache depends more on headache frequency than diagnostic category (eg, migraine or tension-type headaches). (medscape.com)
  • [ 6 ] Furthermore, headache frequency is an important predictor of health-related quality of life. (medscape.com)
  • There may be a bidirectional association between depression, migraines, [ 12 ] and headache characteristics, including frequency, as these factors tend to have a strong influence on anxiety and depression symptoms, as well as on quality of life. (medscape.com)
  • Any suspected adverse events following HPV vaccination during pregnancy should be reported to VAERS. (cdc.gov)
  • Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S. licensed vaccines. (cdc.gov)
  • This online database provides a nationwide mechanism by which VAERS reports are made available to the public and may be reviewed and analyzed. (cdc.gov)
  • On June 30, 2017, VAERS released a new reporting form, called the VAERS 2.0 Report Form. (cdc.gov)
  • This new form replaced the now obsolete VAERS-1 Report Form, which was active from July 1, 1990 to June 29, 2017. (cdc.gov)
  • See the Vaccine Adverse Event Reporting System (VAERS) web site for more information. (cdc.gov)
  • While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. (cdc.gov)
  • Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS even if they are not sure if the vaccine was the cause. (cdc.gov)
  • In some situations, reporting to VAERS is required of healthcare providers and vaccine manufacturers. (cdc.gov)
  • Reports to VAERS can also be biased. (cdc.gov)
  • Data from VAERS reports should always be interpreted with these limitations in mind. (cdc.gov)
  • VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as "safety signals. (cdc.gov)
  • These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events. (cdc.gov)
  • Additionally, CDC and FDA cannot provide individual medical advice regarding any report to VAERS. (cdc.gov)
  • VAERS does not obtain follow up records on every report. (cdc.gov)
  • If a report is classified as serious, VAERS requests additional information, such as health records, to further evaluate the report. (cdc.gov)
  • VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available. (cdc.gov)
  • VAERS data available to the public include only the initial report data to VAERS. (cdc.gov)
  • Additionally, reports to VAERS that appear to be false or fabricated with the intent to mislead CDC and FDA may be reviewed before they are added to the VAERS database. (cdc.gov)
  • Cases listed in VAERS were excluded if another ellow fever virus (YFV) vaccine had been considered explanation for the adverse event was evident in the case the safest of the live-virus vaccines. (cdc.gov)
  • Reporting System (VAERS) (www.vaers.hhs.gov), the decades later ( 13 ). (cdc.gov)
  • Three fatal cases of possible YEL-AVD among young thymectomies secondary to thymoma ( 5 ) are recognized women reported in VAERS were excluded from the Table as groups at risk for YEL-AVD. (cdc.gov)
  • A follow up study by the US Center of Disease Control (CDC) based on the VAERS and V-Safe self-reporting systems 18 further confirms these findings 19 . (nature.com)
  • A systematic review of methods for medical record analysis to detect adverse events in hospitalized patients. (ahrq.gov)
  • At present, data from trials do not confirm or refute an advantage for CR CBZ over IR CBZ for seizure frequency or adverse events in patients with newly diagnosed epilepsy. (cochrane.org)
  • For trials involving epilepsy patients already prescribed IR CBZ, no conclusions can be drawn concerning the superiority of CR CBZ with respect to seizure frequency. (cochrane.org)
  • A change to CR CBZ may therefore be a worthwhile strategy in patients with acceptable seizure control on IR CBZ but experiencing unacceptable adverse events. (cochrane.org)
  • These adverse events may limit the daily dose of CBZ that can be tolerated and reduce the chances of seizure control in patients who require high doses. (cochrane.org)
  • 2) For patients on established treatment with IR CBZ but experiencing unacceptable adverse events, what is the effect on seizure control and the tolerability of a switch to a CR formulation versus remaining on the IR formulation? (cochrane.org)
  • Methods and analysis In this prospective observational study, 20 patients underwent full ophthalmic examination to assess retinal embolic events prior to TAVI and at 48 hours and 1 month post-TAVI. (bmj.com)
  • At 1 month, another two patients had new retinal emboli events in at least one eye and a fourth patient developed retinal splinter haemorrhages in the right eye. (bmj.com)
  • Health care providers must talk to their patients about energy drink use, and report adverse events to watchdog agencies, like the Poison Control Centers, Consumer Product Safety Commission and the FDA. (acsm.org)
  • Despite fears of compromised oxygen delivery in patients with Eisenmenger syndrome during flight on commercial aircraft, a clinical study has shown no adverse effects, and many patients travel frequently. (bmj.com)
  • Thirteen patients with Eisenmenger syndrome reported no travel in the past 10 years (vs 4/48 acyanotic patients, p = 0.03), six of whom were told not to fly by healthcare providers. (bmj.com)
  • Most reports about the safety of commercial air travel concern patients with chronic obstructive lung disease or cystic fibrosis. (bmj.com)
  • 1 - 5 Still, only rare case reports of adverse events from flight in CHD exist, 6 and none in patients with Eisenmenger syndrome specifically. (bmj.com)
  • 7 No significant drop in P o 2 was found in cyanotic patients and no patient had any adverse effect. (bmj.com)
  • The authors concluded that commercial air travel does not place cyanotic patients at adverse risk. (bmj.com)
  • When the patients were given a whole-plant cannabis oil containing THC, CBD, and other cannabinoids as well as compounds including terpenes and flavonoids, the frequency of their seizures decreased by nearly 90 percent. (hightimes.com)
  • Objective To determine if medical marijuana provides pain relief for patients with chronic noncancer pain (CNCP) and to determine the therapeutic dose, adverse effects, and specific indications. (cfp.ca)
  • Over 70% of events were considered preventable. (bmj.com)
  • Preventable adverse events are an ongoing challenge in healthcare. (bmj.com)
  • 2 , 3 Approximately half of the adverse events are preventable. (bmj.com)
  • Prevalence and nature of medication errors and preventable adverse drug events in paediatric and neonatal intensive care settings: a systematic review. (ahrq.gov)
  • Seizure frequency across all 10 participants reduced by 86 percent with no significant adverse events," the authors of the study wrote . (hightimes.com)
  • Antibody kinetics in pregnant women likely in the Morbidity and Mortality Weekly Report ( MMWR ). (cdc.gov)
  • Morbidity and Mortality Weekly Report antipertussis antibody concentrations from maternal delivery lower socioeconomic status, the interval between pregnancies and cord blood pairs from women who received Tdap within generally is 18 months ( 15 ). (cdc.gov)
  • A frequency analysis was done to examine the difference in observed versus expected prevalence (calculated using a contingency table assuming independence across cells) of co-occurring complications or comorbidities. (cdc.gov)
  • The exact frequency of fainting post-immunization is not known but the majority of syncope adverse event reports involve adolescents or adults. (canada.ca)
  • Was the Report Sent to FDA? (fda.gov)
  • Cardiovascular adverse conditions are caused by coronavirus disease 2019 (COVID-19) infections and reported as side-effects of the COVID-19 vaccines. (nature.com)
  • Well-designed and controlled research is required to examine the increasing frequency of adverse events being reported by emergency departments. (acsm.org)
  • There seemed to be no adverse side effects except right after the procedure. (fda.gov)
  • Our review of the available science showed that excessive levels of caffeine found in energy drinks can have adverse effects on cardiovascular, neurological, gastrointestinal, renal and endocrine systems, as well as psychiatric symptoms. (acsm.org)
  • Investment in awareness and educational resources highlighting the potential adverse effects and safe use of energy drinks is required. (acsm.org)
  • A national registry should be set up to specifically track energy drink side effects with mandated reporting requirements. (acsm.org)
  • Few adverse effects, including excessive tiredness before exact dosing was determined, were reported to researchers. (hightimes.com)
  • Data sources In April 2014, MEDLINE and EMBASE searches were conducted using the terms chronic noncancer pain , smoked marijuana or cannabinoids , placebo and pain relief, or side effects or adverse events . (cfp.ca)
  • All experimental sessions in the studies were of short duration (maximum of 5 days) and reported statistically significant pain relief with nonserious side effects. (cfp.ca)
  • Secondary objectives included determining its effect on function, identifying therapeutic doses, and documenting commonly associated adverse effects. (cfp.ca)
  • See Summary of Product Characteristics for full information on side effects, including details of uncommon, rare and very rare events. (acnr.co.uk)
  • It is the opinion of the Risk Identification/Management Work Group that broadcast applications have the greatest potential for adverse human health effects. (cdc.gov)
  • Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that drugs (including medications ) may have. (msdmanuals.com)
  • Balancing Drug Benefits and Adverse Effects Obviously, a drug (or any medical treatment) should be used only when it will benefit a patient. (msdmanuals.com)
  • However, adverse effects after thalidomide exposure in the 1960s and the occurrence in 1970 of methylmercury poisoning among residents of Minamata, Japan, dramatically demonstrated the teratogenic potential of chemical exposures. (cdc.gov)
  • Occupational exposures can produce a wide range of adverse effects on reproduction. (cdc.gov)
  • These results provide important baseline data on the adverse event burden and, alongside web-based chart review, provide an incentive and methodology to monitor future patient-safety initiatives. (bmj.com)
  • Please do not use this form to submit personal or patient medical information or to report adverse drug events. (medscape.com)
  • The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. (bmj.com)
  • An olympus endoscopy account manager (eam) reported that during a therapeutic procedure with an evis exera iii duodenovideoscope, the single-use distal cover developed a crack and fell off into the patient.The cover was retrieved with no reported patient injury. (fda.gov)
  • The GIRFT National report highlighted the need to reduce variations, improve productivity, quality and most importantly patient safety within the NHS," said Julia Taylor, Past President of the British Association of Urological Nurses, Macmillan Consultant Nurse and Clinical Governance Lead, Urology, Salford Royal NHS Foundation Trust. (acnr.co.uk)
  • Therefore, the therapeutic strategy against IPF has shifted from corticosteroids and/or immunosuppressants to antifibrotic agents, as reported in recent clinical trials 5 , 6 . (ersjournals.com)
  • Several reports have shown modulation of Cys-loop receptors by phytocannabinoids and endocannabinoids independent of cannabinoid receptors with potential physiological or therapeutic consequences. (researchgate.net)
  • Management and implications for future immunization are markedly different for these events and it is important to distinguish one from the other as quickly as possible without delaying appropriate therapeutic interventions. (canada.ca)
  • Conclusion Retinal embolic events and new retinal abnormalities following TAVI occurred in 15% and 20% of our cohort, respectively, without any associated retinal damage or significant visual problems. (bmj.com)
  • however, little is known about adverse event occurrence. (bmj.com)
  • Target marketing to sporting and other events involving children and adolescents should not be permitted. (acsm.org)
  • But instead after the 3rd treatment, i was not able to have sexual intercourse at all, plus my urinary frequency got worse. (fda.gov)
  • FINDINGS: 1327 participants who completed the follow-up visit were included in the frequency analysis. (cdc.gov)
  • This report frames the findings of Work Package 2 (WP 2) of the EWENT project. (europa.eu)
  • Flu View is a weekly influenza surveillance report prepared by CDC Influenza Division. (cdc.gov)
  • Conclusions This first study of adverse events in Ireland reports similar rates to other countries. (bmj.com)
  • All parents reported that the whole-plant products were well-tolerated and the children showed improvements in their mood, behavior, eating anding as well as substantial improvements in their cognitive [mental] abilities," said study author Rayyan Zafar, a fellow at the Centre for Psychedelic Research and Neuropsychopharmacology at Imperial College London. (hightimes.com)
  • The study provides the first comprehensive climatology of the adverse and extreme weather events affecting the European transport system by estimating the frequency (or probability) of phenomena for the present climate (1971-2000) and an overview of projected changes in some of these adverse and extreme phenomena in the future climate until 2070. (europa.eu)
  • This study reports on the development and evaluation of a method for measuring operating-theatre teamwork quality. (bmj.com)
  • A controlled-release formulation of CBZ delivers the same dose over a longer period of time when compared to a standard immediate-release formulation, thereby reducing post-dose peaks in CBZ plasma concentration and potentially reducing adverse events. (cochrane.org)
  • Frequency and nature of medication errors and adverse drug events in mental health hospitals: a systematic review. (ahrq.gov)
  • This systematic review found that medication errors and adverse drug events in mental health hospitals are common. (ahrq.gov)
  • Medication safety in mental health hospitals: a mixed-methods analysis of incidents reported to the National Reporting and Learning System. (ahrq.gov)
  • Adverse health events related to self-medication practices among elderly: a systematic review. (ahrq.gov)
  • The United States has experienced substantial increases in tussis in infants, the Advisory Committee on Immunization reported pertussis cases over the past several years. (cdc.gov)
  • Objective To assess the frequency and nature of adverse events in Irish hospitals. (bmj.com)
  • You are encouraged to report adverse drug event information to the FDA. (medscape.com)
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. (medicinenet.com)
  • The writing group used the rating system of the National Heart Lung and Blood Institute ( Table 1 ) and a consensus approach to synthesize the available evidence from clinical trials and case reports, narrative and systematic reviews, and meta-analyses ( 3 ). (lww.com)
  • The frequency and amount applied in these cases was not systematic and varied widely among residences. (cdc.gov)
  • Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. (medicines.org.uk)
  • Available safety data for PAXLOVID has been generally consistent in more than 3,500 PAXLOVID-treated participants across the EPIC-HR, EPIC-SR and EPIC-PEP studies, as well as in reported post-market safety experience. (pfizer.com)
  • Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. (cdc.gov)
  • A review of published and other data suggested a higher than expected number of deaths reports from the ProMED Web site (http://apex.oracle. (cdc.gov)
  • All data are preliminary and may change as CDC receives more reports. (cdc.gov)
  • Frequency and probability analysis of past and present extremes were performed using observational and reanalysis data. (europa.eu)
  • RESULTS: Glucose Ra in fasted HV was consistent with previously reported data. (bvsalud.org)
  • Conclusion Higher migraine frequency, either with or without auras, correlated with higher symptom scores of anxiety and depression. (medscape.com)
  • This combination of factors has previously been identified in teams working in other complex, high-risk environments, 2 and analogies between healthcare and other industries have been frequently and plausibly made, 3 - 5 supported by observations of the relationship in the operating theatre between potential adverse events and deficiencies in teamwork behaviour and coordination. (bmj.com)
  • Those events and the increasing entry of women into the workforce focused greater attention on the potential hazards to female reproductive function of occupational exposures. (cdc.gov)
  • In a time of austerity, adverse events in adult inpatients were estimated to cost over €194 million. (bmj.com)
  • International studies demonstrate that 3%-17% of admissions are associated with an adverse event (defined as an injury caused by healthcare management resulting in prolonged hospitalisation, disability on discharge or death 1 ). (bmj.com)
  • Although selection bias may have associated Deaths infl uenced the cases reported, the sex-specifi c survival rates for these 2 age groups statistically differed: 21% (3/14) in Young Women1 versus 0% (0/6) (p = 0.002 by Fisher exact test). (cdc.gov)
  • Since it was first reported in Vietnam in 2003, the disease has been responsible for human outbreaks and deaths in 15 countries in Asia, Europe, Middle East and Africa resulting in 603 human cases including 356 deaths. (who.int)
  • Climate change will affect, in profoundly adverse ways, some of the most fundamental determinants of health: food, air and water. (who.int)