Improving vaccine safety through a better understanding of vaccine adverse events.
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ABSTRACT:
SUBMITTER: Pasternak B
PROVIDER: S-EPMC4425825 | biostudies-literature | 2015 May
REPOSITORIES: biostudies-literature
Publications
Improving vaccine safety through a better understanding of vaccine adverse events.
Pasternak Björn B Feenstra Bjarke B Melbye Mads M Hviid Anders A
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20150203 10
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Project description:Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines. Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate.
| S-EPMC4514437 | biostudies-other
Project description:The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all US licensed vaccines. In March 2008, ACAM2000(®) replaced Dryvax(®) as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000(®).During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000(®)and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA(®)) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions.VAERS received 1149 reports following ACAM2000(®) administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA(®) search found 31 reports of possible ICE after receipt of ACAM2000(®) vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases.Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000(®). Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon.
| S-EPMC5946322 | biostudies-other
Project description:While vaccines are crucial to end the COVID-19 pandemic, public confidence in vaccine safety has always been vulnerable. Many statistical methods have been applied to VAERS (Vaccine Adverse Event Reporting System) database to study the safety of COVID-19 vaccines. However, none of these methods considered the adverse event (AE) ontology. AEs are naturally related; for example, events of retching, dysphagia, and reflux are all related to an abnormal digestive system. Explicitly bringing AE relationships into the model can aid in the detection of true AE signals amid the noise while reducing false positives. We propose a Bayesian graph-assisted signal selection (BGrass) model to simultaneously estimate all AEs while incorporating the network of dependence between AEs. Under a fully Bayesian inference framework, we also propose a negative control approach to mitigate the reporting bias and an enrichment approach to detecting AE groups of concern. For posterior computation we construct an equivalent model representation and develop an efficient Gibbs sampler. We evaluate the performance of BGrass via extensive simulations. To study the safety of COVID-19 vaccines, we apply BGrass to analyze approximately one million VAERS reports (01/01/2016-12/24/2021) involving more than 800 AEs. In particular, we found that blood clots (including deep vein thrombosis, thrombosis, and pulmonary embolism) are more likely to be reported after COVID-19 vaccination, compared to influenza vaccines. They are also reported more often for Johnson & Johnson-Janssen vaccine, compared to mRNA-based COVID-19 vaccines. A user-friendly R package BGrass that implements the proposed methods to assess vaccine safety is included in the Supplementary Material and is publicly available at https://github.com/BangyaoZhao/BGrass.
| S-EPMC11395664 | biostudies-literature
Project description:BackgroundEstablishing a positive safety-culture environment is essential in healthcare settings to enhance patient care. This study aimed to determine the relationship between critical care nurses' perceptions of patient safety culture and adverse events.MethodsA cross-sectional study was conducted among 200 nurses working in critical care units in the Damanhour Governorate in Egypt. Data were collected using a self-administered questionnaire, including the Hospital Survey of Patients' Safety Culture (HSOPSC) and information on adverse events (AEs).ResultsThe study revealed areas for improvement in patient safety culture, with low positive response rates in staffing (26.6%), non-punitive response to errors (38%), handoffs and transitions (39.4%), teamwork across and within units (42.3%), and overall perception of patient safety (49.3%). The majority of critical care nurses had a moderate to high level of overall perception of patient safety at 42.5% and 42.0%, respectively. The most frequent adverse events reported daily were complaints from patients or their families (65.5%). Adverse drug events and patient falls occurred several times per week in 56.5% and 57.0% of patients, respectively. A significant association was found between low safety culture perception and higher rates of patient falls (p = .008), adverse drug events (p = .005), and patient/family complaints (p = .030).ConclusionThe findings of the study indicate that nurses' perceptions of patient safety culture are moderate. Adverse medication responses, falls, and complaints from patients or their families were noted. Female nurses aged 31 to 40, especially divorced nurses, had more experience, worked fewer than 8 h daily, and had a higher education level, which appeared to influence overall safety culture perceptions. Furthermore, there was a correlation between the prevalence of adverse events and patient safety culture, with cooperation being the key factor.
| S-EPMC11536378 | biostudies-literature
Project description:Despite the efficacy, safety, and availability of COVID-19 vaccines, a lack of awareness and trust of vaccine safety research remains an important barrier to public health. The goal of this research was to design and test online meta-summaries-transparent, interactive summaries of the state of relevant studies-to improve people's awareness and opinion of vaccine safety research. We used insights from a set of co-design interviews (n = 22) to develop meta-summaries to highlight metascientific information about vaccine safety research. An experiment with 863 unvaccinated participants showed that our meta-summaries increased participants' perception of the amount, consistency, and direction of vaccine safety research relative to the U.S. Center for Disease Control (CDC) webpage, and that participants found them more trustworthy than the CDC page as well. They were also more likely to discuss it with others in the week following. We conclude that direct summaries of scientific research can be a useful communication tool for controversial scientific topics.
| S-EPMC9676710 | biostudies-literature
Project description:ObjectiveAutomated analysis of vaccine postmarketing surveillance narrative reports is important to understand the progression of rare but severe vaccine adverse events (AEs). This study implemented and evaluated state-of-the-art deep learning algorithms for named entity recognition to extract nervous system disorder-related events from vaccine safety reports.Materials and methodsWe collected Guillain-Barré syndrome (GBS) related influenza vaccine safety reports from the Vaccine Adverse Event Reporting System (VAERS) from 1990 to 2016. VAERS reports were selected and manually annotated with major entities related to nervous system disorders, including, investigation, nervous_AE, other_AE, procedure, social_circumstance, and temporal_expression. A variety of conventional machine learning and deep learning algorithms were then evaluated for the extraction of the above entities. We further pretrained domain-specific BERT (Bidirectional Encoder Representations from Transformers) using VAERS reports (VAERS BERT) and compared its performance with existing models.Results and conclusionsNinety-one VAERS reports were annotated, resulting in 2512 entities. The corpus was made publicly available to promote community efforts on vaccine AEs identification. Deep learning-based methods (eg, bi-long short-term memory and BERT models) outperformed conventional machine learning-based methods (ie, conditional random fields with extensive features). The BioBERT large model achieved the highest exact match F-1 scores on nervous_AE, procedure, social_circumstance, and temporal_expression; while VAERS BERT large models achieved the highest exact match F-1 scores on investigation and other_AE. An ensemble of these 2 models achieved the highest exact match microaveraged F-1 score at 0.6802 and the second highest lenient match microaveraged F-1 score at 0.8078 among peer models.
| S-EPMC8279785 | biostudies-literature
Project description:IntroductionStatistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. The unprecedented environment created by the coronavirus disease 2019 (COVID-19) pandemic for vaccine surveillance predisposes commonly applied signal detection methodologies to a statistical issue called the masking effect, in which signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines.ObjectiveThe aim is to investigate the problem of masking in the context of COVID-19 vaccine signal detection, assessing its impact, extent, and root causes.MethodsBased on data underlying the Vaccine Adverse Event Reporting System, three commonly applied statistical signal detection methodologies, and a more advanced regression-based methodology, we investigate the temporal evolution of signals corresponding to five largely recognized adverse events and two potentially new adverse events.ResultsThe results demonstrate that signals of adverse events related to COVID-19 vaccines may be undetected or delayed due to masking when generated by methodologies currently utilized by pharmacovigilance organizations, and that a class of advanced methodologies can partially alleviate the problem. The results indicate that while masking is rare relative to all possible statistical associations, it is much more likely to occur in COVID-19 vaccine signaling, and that its extent, direction, impact, and roots are not static, but rather changing in accordance with the changing nature of data.ConclusionsMasking is an addressable problem that merits careful consideration, especially in situations such as COVID-19 vaccine safety surveillance and other emergency use authorization products.
| S-EPMC9219360 | biostudies-literature
Project description:Using meta-analytic methods, we calculated expected rates of 20 potential adverse events of special interest (AESI) that would occur after coronavirus disease 2019 (COVID-19) vaccination within 1-, 7-, and 42-day intervals without causal associations. Based on these expected rates, if 10 000 000 persons are vaccinated, (1) 0.5, 3.7, and 22.5 Guillain-Barre syndrome cases, (2) 0.3, 2.4, and 14.3 myopericarditis cases, (3) and 236.5, 1655.5, and 9932.8 all-cause deaths would occur coincidentally within 1, 7, and 42 days postvaccination, respectively. Expected rates of potential AESI can contextualize events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine health communications, and inform COVID-19 vaccine benefit-risk assessments.
| S-EPMC8755334 | biostudies-literature
Project description:ObjectiveThis study aimed to assess nurses' perceptions of patient safety culture (PSC) and its relationship with adverse events in Hail City, Saudi Arabia.DesignA cross-sectional study was conducted between 1 August 2023 and the end of November 2023 at 4 governmental hospitals and 28 primary healthcare centres.SettingHail City, Saudi Arabia.ParticipantsData were collected from 336 nurses using 3 instruments: demographic and work-related questions, PSC and adverse events.ResultsNurses had positive responses in the dimensions of 'teamwork within units' (76.86%) and 'frequency of events reported' (77.87%) but negative responses in the dimensions of 'handoffs and transitions' (18.75%), 'staffing' (20.90%), 'non-punitive response to errors' (31.83%), 'teamwork across units' (34.15%), 'supervisor/manager expectations' (43.22%) and 'overall perception of patient safety' (43.23%). Significant associations were found between nationality, experience, current position and total safety culture, with p values of 0.015, 0.046 and 0.027, respectively. Nurses with high-ranking perceptions of PSC in 'handoffs and transitions,' 'staffing' and 'teamwork across hospital units' reported a lower incidence of adverse events than those with low-ranking perceptions, particularly in reporting pressure ulcers (OR 0.86, 95% CI 0.78 to 0.94, OR 0.82, 95% CI 0.71 to 0.94 and OR 0.83, 95% CI 0.70 to 0.99, respectively) (p<0.05). Nurses with high-ranking perceptions of PSC in UK 'handoffs and transitions' reported a lower incidence of patient falls. Similarly, those with high-ranking perceptions in both 'handoffs and transitions' and 'overall perception of patient safety reported a lower incidence of adverse events compared with those with low-ranking perceptions, especially in reporting adverse drug events (OR 0.83, 95% CI 0.76 to 0.91 and OR 0.75, 95% CI 0.61 to 0.92, respectively) (p<0.05).ConclusionFrom a nursing perspective, hospital PSCs have both strengths and weaknesses. Examples include low trust in leadership, staffing, error-reporting and handoffs. Therefore, to improve staffing, communication, handoffs, teamwork, and leadership, interventions should focus on weak areas of low confidence and high rates of adverse events.
| S-EPMC11381649 | biostudies-literature
Project description:A COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) has recently been authorized for adolescents in the US. However, the impact of adverse events on adolescents after vaccination has not been fully investigated. To assess the safety of the COVID-19 vaccine in adolescents, the incidence of adverse events (AEs) in adolescents and adults was compared after vaccination. We included 6304 adolescents (68.14 per 100,000 people) who reported adverse events using vaccine adverse event reporting system (VAERS) data from 10 May 2021 to 30 September 2021. The mean age was 13.6 ± 1.1 years and women (52.7%) outnumbered men. We analyzed severe and common adverse events in response to the COVID-19 vaccine among 6304 adolescents (68.14 per 100,000 people; 52% female; mean age, 13.6 ± 1.1 years). The risk of myocarditis or pericarditis among adolescents was significantly higher in men than in women (OR = 6.61, 95% CI = 4.43 to 9.88; p < 0.001), with a higher frequency after the second dose of the vaccine (OR = 8.52, 95% CI = 5.79 to 12.54; p < 0.001). In addition, severe adverse events such as multisystem inflammatory syndromes, where the incidence rate per 100,000 people was 0.11 (n = 10), and the relative risk was 244.3 (95% CI = 31.27 to 1908.38; p < 0.001), were significantly higher in adolescents than in adults. The risk of the inflammatory response to the COVID-19 vaccine, including myocarditis, pericarditis, or multisystem inflammatory syndromes, was significantly higher in men than in women, with a higher frequency in adolescents than in adults. The inflammation-related AEs may require close monitoring and management in adolescents.
| S-EPMC9143867 | biostudies-literature