OAE: The Ontology of Adverse Events

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data

OAE: The Ontology of Adverse Events

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data

Drug Saf

Introduction:Routine immunization of pregnant women with seasonal inactivated influenza vaccines (IIV) is recommended in all trimesters of pregnancy. A review of the Vaccine Adverse Event Reporting System (VAERS) during 1990\u20132009 did not find any unexpected patterns of pregnancy complications or fetal outcomes after administration of IIV or live attenuated influenza vaccines (LAIV). During 2009\u20132010 pandemic H1N1 vaccination campaign, a study noted that the numbers of VAERS reports from pregnant women who received the influenza A (H1N1) 2009 inactivated monovalent vaccine (N=288) increased compared to 1990\u20132009 seasonal IIV pregnancy reports (N=148).Objectives:To assess the safety of seasonal influenza vaccines in pregnant women and their infants whose reports were submitted to VAERS during 2010\u20132016.Methods:We searched VAERS for US reports of adverse events (AEs) in pregnant women who received IIV or LAIV from 7/1/2010\u20135/06/2016. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious, based on the Code of Federal Regulations.Results:We identified 671 reports after seasonal influenza vaccines administered to pregnant women: 544 after IIV and 127 after LAIV. Serious events occurred among 61 (11.2%) reports following IIV and 1 (0.8%) report following LAIV. No deaths were reported. Among reports with trimester information (n=296), IIV was administered during the first trimester in 116 (39.2%). Among IIV reports, the most frequent pregnancy-specific AE was spontaneous abortion in 62 (11.4%) reports, followed by stillbirth in 10 (1.8%) and preterm delivery in 6 (1.1%). The most common non-pregnancy specific AEs were injection site reactions (55, 10.1%). Neonatal or infant outcomes were reported in 22 (4.0%) reports, 7 of which had major birth defects of different types and no neonatal deaths.Conclusion:As in 2009\u20132010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010\u20132016.CC999999/Intramural CDC HHS/United States2019-07-01T00:00:00Z27988883PMC66020656428vault:3248

Am J Obstet Gynecol

Objective:To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received Influenza A (H1N1) 2009 Monovalent Vaccine to assess for potential vaccine safety problems.Methods:We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from 10/0\ubd009\u201302/28/2010.Results:VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine (20.1%) women were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks), 18 stillbirths ( 6520 weeks), 7 preterm deliveries (<37 weeks), 3 threatened abortions, 2 preterm labor, 2 preeclampsia, and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip.Conclusions:Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.CC999999/Intramural CDC HHS/United States2019-07-01T00:00:00Z21861964PMC66020566428vault:3248

Ontology-Based Combinatorial Comparative Analysis of Adverse Events Associated with Killed and Live Influenza Vaccines

Vaccine adverse events (VAEs) are adverse bodily changes occurring after vaccination. Understanding the adverse event (AE) profiles is a crucial step to identify serious AEs. Two different types of seasonal influenza vaccines have been used on the market: trivalent (killed) inactivated influenza vaccine (TIV) and trivalent live attenuated influenza vaccine (LAIV). Different adverse event profiles induced by these two groups of seasonal influenza vaccines were studied based on the data drawn from the CDC Vaccine Adverse Event Report System (VAERS). Extracted from VAERS were 37,621 AE reports for four TIVs (Afluria, Fluarix, Fluvirin, and Fluzone) and 3,707 AE reports for the only LAIV (FluMist). The AE report data were analyzed by a novel combinatorial, ontology-based detection of AE method (CODAE). CODAE detects AEs using Proportional Reporting Ratio (PRR), Chi-square significance test, and base level filtration, and groups identified AEs by ontology-based hierarchical classification. In total, 48 TIV-enriched and 68 LAIV-enriched AEs were identified (PRR.2, Chi-square score .4, and the number of cases .0.2% of total reports). These AE terms were classified using the Ontology of Adverse Events (OAE), MedDRA, and SNOMED-CT. The OAE method provided better classification results than the two other methods. Thirteen out of 48 TIV-enriched AEs were related to neurological and muscular processing such as paralysis, movement disorders, and muscular weakness. In contrast, 15 out of 68 LAIV-enriched AEs were associated with inflammatory response and respiratory system disorders. There were evidences of two severe adverse events (Guillain-Barre Syndrome and paralysis) present in TIV. Although these severe adverse events were at low incidence rate, they were found to be more significantly enriched in TIVvaccinated patients than LAIV-vaccinated patients. Therefore, our novel combinatorial bioinformatics analysis discovered that LAIV had lower chance of inducing these two severe adverse events than TIV. In addition, our meta-analysis found that all previously reported positive correlation between GBS and influenza vaccine immunization were based on trivalent influenza vaccines instead of monovalent influenza vaccines.This work was supported by the National Institutes of Health (NIH) grant U54 DA021519 for the National Center for Integrative Biomedical Informatics and NIH National Institute of Allergy and Infectious Diseases (NIAID) grant R01AI081062. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/99110/1/journal.pone.0049941.pd

Vaccine

Background:The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine.Objective:To assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS).Methods:We searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period.Results:Out of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period.Conclusion:More than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs.CC999999/Intramural CDC HHS/United States2019-12-22T00:00:00Z31155414PMC69259727007vault:3428

Vaccine

Background:In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax\uae, ccIIV3), was approved in the US for adults aged 6518 years.Objective:To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.Methods:We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barr\ue9 syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3.Results:VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons < 18 years.; Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for \u2018drug administered to patient of inappropriate age.\u2019Conclusions:Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use.20152019-05-04T00:00:00ZCC999999/Intramural CDC HHS/United States26518405PMC6500456704

Am J Obstet Gynecol

Objective:To characterize adverse events (AEs) after Hepatitis A vaccines (Hep A) and Hepatitis A and Hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.Study design:We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from 01/01/1996-04/05/2013. Clinicians reviewed all reports and available medical records.Results:VAERS received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; No maternal or infant deaths were identified. Sixty-five (46.8%) did not describe an AE. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and pre-term delivery in 7 (5.0%) reports. The most common non-pregnancy specific outcome was urinary tract infection and nausea vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization.Conclusions:This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal HepA or HepAB immunizations during pregnancy.CC999999/Intramural CDC HHS/United States2019-05-04T00:00:00Z24378675PMC6500450752

Pediatrics

Objective:To assess the safety of currently licensed diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines in the US using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.Methods:We searched VAERS for US reports for DTaP vaccinations occurring during January 1, 1991, through December 31, 2016, and received by March 17, 2017. We reviewed available medical records for all death reports and a random sample of reports classified as non-death serious. We used empirical Bayesian data mining to identify adverse events that were disproportionally reported after DTaP vaccination.Results:VAERS received 50,157 reports after DTaP vaccination; 43,984 (87.7%) of them reported concomitant administration of other vaccines, and 5,627 (11%) were serious. Median age at vaccination was 19 months (interquartile range 35 months). The most frequently reported events were injection site erythema (12,695; 25.3%), pyrexia (9,913; 19.8%), injection site swelling (7,542; 15.0%), erythema (5,594; 11.2%), and injection site warmth (4,793; 9.6%). For three of the DTaP vaccines, empirical Bayesian data mining identified elevated values for vaccination errors.Conclusion:No new or unexpected AEs were detected. The observed disproportionate reporting for some non-serious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines.CC999999/Intramural CDC HHS/United States2019-04-22T00:00:00Z29866795PMC64765546436vault:3194