Adverse Events Following COVID-19 Vaccine in Patients Previously Injected with Facial Filler: Scoping Review and Case Report

The “Vaccines and Related Biological Products Advisory Committee 17 December 2020 Meeting Briefing Document”, formulated by the FDA, reported three cases of swelling in areas previously injected with HA filler, introducing the possible relationship between a COVID-19 vaccine and adverse events in areas previously injected with HA fillers. The aim of this research is to report a case of an adverse event following a COVID-19 vaccine in a patient previously injected with facial filler. Furthermore, a scoping review on the same topic was performed. The research was carried out on the electronic databases PubMed, Cochrane Library, Web of Science, Google Scholar and Scopus. The selection process identified four articles as eligible for inclusion in the review. Nineteen patients, including the described case report, who experienced an adverse event following a COVID-19 vaccine in areas previously injected with facial filler were identified. Adverse events following a COVID-19 vaccine in patients previously injected with facial filler appear to be rare. A high BDDE cross-linking rate and/or a low-molecular-weight hyaluronic acid filler may have a higher tardive adverse event rate when triggered.

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Functionalized Nanoparticles Activated by Photodynamic Therapy as an Antimicrobial Strategy in Endodontics: A Scoping Review

Antibiotics ◽

10.3390/antibiotics10091064 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1064

Author(s):

Pablo Betancourt ◽

Nadia Brocal ◽

Eulàlia Sans-Serramitjana ◽

Carlos Zaror

Keyword(s):

Photodynamic Therapy ◽

Scoping Review ◽

Selection Process ◽

Data Extraction ◽

Cochrane Library ◽

Qualitative Synthesis ◽

Promising Alternative ◽

Root Canals ◽

Low Cytotoxicity

The eradication of endodontic pathogens continues to be the focus of the search for new root canal system (RCS) disinfection strategies. This scoping review provides a comprehensive synthesis of antimicrobial photodynamic therapy (aPDT) using nanoparticles (NPs) as an alternative to optimize RCS disinfection. A systematic search up to March 2021 was carried out using the MEDLINE, EMBASE, Scopus, Lilacs, Central Cochrane Library, and BBO databases. We included studies focused on evaluating the activation of NPs by aPDT in inoculated root canals of human or animal teeth or bacterial cultures in the laboratory. The selection process and data extraction were carried out by two researchers independently. A qualitative synthesis of the results was performed. A total of seventeen studies were included, of which twelve showed a substantial antibacterial efficacy, two assessed the substantivity of the disinfection effect, and three showed low cytotoxicity. No adverse effects were reported. The use of functionalized NPs with photosensitizer molecules in aPDT has been shown to be effective in reducing the bacteria count, making it a promising alternative in endodontic disinfection. Further studies are needed to assess the development of this therapy in in vivo conditions, with detailed information about the laser parameters used to allow the development of safe and standardized protocols.

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The Relationship between Use of Low Molecular Weight Heparin during Pregnancy and Risk of Peripartum Adverse Events: A Meta-Analysis

Annals of Hematology & Oncology ◽

10.26420/annhematoloncol.2021.1372 ◽

2021 ◽

Vol 8 (11) ◽

Author(s):

Xiaorong Y ◽

◽

Shan L ◽

Shengji S ◽

Tao S ◽

...

Keyword(s):

Molecular Weight ◽

Adverse Events ◽

Pregnant Women ◽

Low Molecular Weight Heparin ◽

Meta Analysis ◽

Cochrane Library ◽

Premature Delivery ◽

Low Molecular Weight ◽

Significant Difference ◽

Fetal Complications

Introduction: To summarize the trials investigated on relationship between low molecular weight heparin use during pregnancy and peripartum adverse events. Meta-analysis was performed to evaluate the effect of Low Molecular Weight Heparin (LMWH) on maternal and fetal complications. Methods: Electronic research was performed in Cochrane Library, MEDLINE and EMBASE through October 2020. The primary outcome was the incidence of maternal and fetal complications during peripartum period. RevMan 5.3 was used for data analysis. Results: 11 articles were finally included. Meta-analysis showed there was no significant difference in abortion, premature delivery, stillbirth, preeclampsia and postpartum hemorrhage events between pregnant women who used LMWH and those who not. Conclusion: Using LMWH in pregnant women does not increase pregnancy related maternal and fetal complications.

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Delayed Ileal Pouch Anal Anastomosis Has a Lower 30-Day Adverse Event Rate: Analysis From the National Surgical Quality Improvement Program

Inflammatory Bowel Diseases ◽

10.1093/ibd/izy082 ◽

2018 ◽

Vol 24 (8) ◽

pp. 1833-1839 ◽

Cited By ~ 4

Author(s):

Bharati Kochar ◽

Edward L Barnes ◽

Anne F Peery ◽

Katherine S Cools ◽

Joseph Galanko ◽

...

Keyword(s):

Adverse Event ◽

Quality Improvement ◽

Adverse Events ◽

Ileal Pouch ◽

Ileal Pouch Anal Anastomosis ◽

Quality Improvement Program ◽

Adverse Event Rate ◽

Improvement Program ◽

Surgical Quality ◽

Anal Anastomosis

Abstract Background Ulcerative colitis (UC) patients requiring colectomy often have a staged ileal pouch anal anastomosis (IPAA). There are no prospective data comparing timing of pouch creation. We aimed to compare 30-day adverse event rates for pouch creation at the time of colectomy (PTC) with delayed pouch creation (DPC). Methods Using prospectively collected data from 2011–2015 through the National Surgical Quality Improvement Program, we conducted a cohort study including subjects aged ≥18 years with a postoperative diagnosis of UC. We assessed 30-day postoperative rates of unplanned readmissions, reoperations, and major and minor adverse events (AEs), comparing the stage of the surgery where the pouch creation took place. Using a modified Poisson regression model, we estimated risk ratios (RRs) with 95% confidence intervals (CIs) adjusting for age, sex, race, body mass index, smoking status, diabetes, albumin, and comorbidities. Results Of 2390 IPAA procedures, 1571 were PTC and 819 were DPC. In the PTC group, 51% were on chronic immunosuppression preoperatively, compared with 15% in the DPC group (P < 0.01). After controlling for confounders, patients who had DPC were significantly less likely to have unplanned reoperations (RR, 0.42; 95% CI, 0.24–0.75), major AEs (RR, 0.72; 95% CI, 0.52–0.99), and minor AEs (RR, 0.48; 95% CI, 0.32–0.73) than PTC. Conclusions Patients undergoing delayed pouch creation were at lower risk for unplanned reoperations and major and minor adverse events compared with patients undergoing pouch creation at the time of colectomy.

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Comparing Demographic Characteristics and Adverse Event Rates at Two Dermatologic Surgery Practices

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2014.13119 ◽

2014 ◽

Vol 18 (5) ◽

pp. 337-340 ◽

Cited By ~ 6

Author(s):

Jenna L. O'Neill ◽

Brandon Shutty ◽

Yun Sun Lee ◽

James A. Solomon ◽

Nikita Patel ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Geographic Location ◽

Common Adverse Event ◽

Adverse Event Rate ◽

Dermatologic Surgery ◽

Patient Demographics ◽

Logistic Regression Procedure ◽

Event Rates ◽

Procedure Type

Background: Patient demographics and operative techniques may contribute to adverse events after surgeries. Objective: To identify differences in adverse event rates between different dermatologic surgery centers and potential contributing features affecting these rates. Methods: Data regarding demographics, procedure type, and adverse events were collected at two dermatologic surgery centers. Results: The most common adverse event at both sites was infection: 2.1% at site 1 versus 0.5% at site 2 ( p < .001). Using multivariate logistic regression, procedure type (Mohs surgery), geographic location (being at site 1), older age, and anatomic location of surgery were associated with a higher risk of infection. Conclusion: Adverse event rate appears to correlate with patient demographics, procedure type, and setting of surgery more than use of prophylactic antibiotics. Identification of differences in adverse event rates and potential contributing variables at different practices may allow for identification of opportunities to prevent adverse events.

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User interface approaches implemented with automated patient deterioration surveillance tools: protocol for a scoping review

BMJ Open ◽

10.1136/bmjopen-2021-055525 ◽

2022 ◽

Vol 12 (1) ◽

pp. e055525

Author(s):

Yik-Ki Jacob Wan ◽

Guilherme Del Fiol ◽

Mary M McFarland ◽

Melanie C Wright

Keyword(s):

Machine Learning ◽

User Interface ◽

Adverse Events ◽

Scoping Review ◽

English Language ◽

Learning Algorithms ◽

Sudden Cardiac Arrest ◽

Machine Learning Algorithms ◽

Cochrane Library ◽

Patient Deterioration

IntroductionEarly identification of patients who may suffer from unexpected adverse events (eg, sepsis, sudden cardiac arrest) gives bedside staff valuable lead time to care for these patients appropriately. Consequently, many machine learning algorithms have been developed to predict adverse events. However, little research focuses on how these systems are implemented and how system design impacts clinicians’ decisions or patient outcomes. This protocol outlines the steps to review the designs of these tools.Methods and analysisWe will use scoping review methods to explore how tools that leverage machine learning algorithms in predicting adverse events are designed to integrate into clinical practice. We will explore the types of user interfaces deployed, what information is displayed, and how clinical workflows are supported. Electronic sources include Medline, Embase, CINAHL Complete, Cochrane Library (including CENTRAL), and IEEE Xplore from 1 January 2009 to present. We will only review primary research articles that report findings from the implementation of patient deterioration surveillance tools for hospital clinicians. The articles must also include a description of the tool’s user interface. Since our primary focus is on how the user interacts with automated tools driven by machine learning algorithms, electronic tools that do not extract data from clinical data documentation or recording systems such as an EHR or patient monitor, or otherwise require manual entry, will be excluded. Similarly, tools that do not synthesise information from more than one data variable will also be excluded. This review will be limited to English-language articles. Two reviewers will review the articles and extract the data. Findings from both researchers will be compared with minimise bias. The results will be quantified, synthesised and presented using appropriate formats.Ethics and disseminationEthics review is not required for this scoping review. Findings will be disseminated through peer-reviewed publications.

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ENDOSCOPIC PAPILLECTOMY FOR EARLY AMPULLARY NEOPLASTIC LESIONS - A CASE SERIES ANALYSIS

Arquivos de Gastroenterologia ◽

10.1590/s0004-2803.202000000-55 ◽

2020 ◽

Vol 57 (3) ◽

pp. 300-305

Author(s):

Nelson Silveira CATHCART JR ◽

Raquel Canzi Almada de SOUZA ◽

Rafael William NODA ◽

Eloy TAGLIERI ◽

José Celso ARDENGH ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Residual Tumor ◽

High Grade Dysplasia ◽

Adverse Event Rate ◽

High Grade ◽

Technical Success ◽

Curative Intent ◽

Endoscopic Papillectomy ◽

Neoplastic Lesions

ABSTRACT BACKGROUND: Endoscopic papillectomy has been conceived as a less invasive therapeutic option for treatment of early neoplastic lesions located at the major duodenal papilla. OBJECTIVE: Evaluating patients with early ampullary lesions who underwent curative intent endoscopic papillectomy related to technical success (histopathological tumor margin assessment) and safety (adverse event rate). METHODS: A retrospective study including consecutive patients who underwent curative intent endoscopic papillectomy for demographic, histopathological and pre-/post-procedural clinical assessment. Endpoints were technical success (histopathological residual tumor assessment) and adverse events rates. RESULTS: A total of 21 medical records patients with a female predominance (13 cases, 61.9%) were included. The tumor was incidental in 8 (38%) cases. Negative residual tumor resection margin rate was 72% (15 cases); three of these cases confirmed high-grade dysplasia in the resected specimen, and six cases were invasive neoplasia. Tumoral recurrence was seen in two cases, and median follow-up time was 12 months, with a 23% loss rate (five patients). Six (28.5%) patients had adverse events, all of them early (bleeding and pancreatitis); none of them required surgical intervention and there was no mortality. CONCLUSION: Endoscopic papillectomy allowed for technical successful procedure with complete removal of ampullary neoplastic lesions in the majority of cases with acceptable adverse event rates. Recurrence rate should be carefully assessed in further studies. There was a recent increase in the number of procedures. There was also a low correlation between pre- and post-histopathological assessment regarding the presence of invasive carcinoma and adenoma with high grade dysplasia, with a predominance of superficial neoplastic adenomatous lesions.

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Abstract P176: Metabolic Side Effects Of Systemic Corticosteroids - A Systematic Review

Hypertension ◽

10.1161/hyp.76.suppl_1.p176 ◽

2020 ◽

Vol 76 (Suppl_1) ◽

Author(s):

Spoorthy Kulkarni ◽

Hannah Durham ◽

Luke Glover ◽

Leslie Cousens ◽

Parmis Blomgran ◽

...

Keyword(s):

Side Effects ◽

Adverse Events ◽

Event Rate ◽

Risk Of Bias ◽

Adverse Event Rate ◽

Cochrane Library ◽

Exclusion Criteria ◽

Metabolic Side Effects ◽

Onset Diabetes ◽

New Onset

Introduction: Metabolic adverse events associated with corticosteroid therapy (CT) are seen as a necessary evil in the management of a wide variety of inflammatory conditions. Evidence on the burden of dysglycaemia associated with CT strategies is mostly based on case- control studies. The aim of this study was to quantify metabolic side effects of systemic steroids as reported in randomised clinical trials (RCT). Methods: We searched Medline, Embase, Cochrane Library, Web of Science and Scopus for studies reporting adverse effects of CT in trials since database inception to 13/01/2020. We used a standardised data extraction form to collect information from eligible studies using predefined inclusion and exclusion criteria. Cochrane risk of bias tool 2 (ROB2) was used to assess risk of bias in the RCTs. The study was registered prospectively with PROSPERO (CRD42020161270). Results: The search identified 5446 studies. In total 120 blinded studies were identified for the mixed method review of AEs. There was significant heterogeneity with respect to steroid dose, treatment duration, condition treated, exclusion criteria in the studies, data collection methods for adverse events (AE) and definition for specific AEs. A significant increase in cases of new onset diabetes, hyperglycaemia, episodes of rise in blood pressure (BP) was noted. Average adverse event rate for new onset of diabetes in the studies (N=21, 27 CT arms) was 4.8% (72 events in 1477 participants, range: 0.85%-18.75%). Event rate of hyperglycaemia in the CT arms was 11.8% approximately (53 CT arms, 222 events in 1854 participants, range: 2.5%-69%). Rise in BP was reported in 53 CT arms in 42 studies, with average event rate of 12.8% (160 events in 1251 participants, range: 0.94%-30.4%). Other significant AEs associated with steroid use included weight gain, dyslipidaemia, insomnia, infections, osteoporosis and fractures. Conclusions: Risk of new onset diabetes and worsening of diabetes control is significant in patients treated with CT, although available evidence to estimate risk is heterogenous. Both, alternatives to corticosteroids which do not elevate blood glucose and accurate estimation of risk of dysglycaemia from well-designed prospective RCTs are urgently required.

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Surgical timing and presence of a vitreoretinal fellow on postoperative adverse events following pars plana vitrectomy

European Journal of Ophthalmology ◽

10.1177/1120672118811980 ◽

2018 ◽

Vol 30 (1) ◽

pp. 81-87

Author(s):

Ryan A Shields ◽

Cassie A Ludwig ◽

Matthew A Powers ◽

Jonathan D Tijerina ◽

Ira H Schachar ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Pars Plana Vitrectomy ◽

Vitreous Hemorrhage ◽

Adverse Event Rate ◽

Start Time ◽

School Of Medicine ◽

Pars Plana ◽

Independent Risk Factors ◽

Postoperative Vitreous Hemorrhage

Introduction: To evaluate the adverse event rate following pars plana vitrectomy as a function of surgical start time and the presence of a vitreoretinal fellow. Methods: Single-institution retrospective cohort study of patients undergoing pars plana vitrectomy from 1 January 2016 to 31 December 2016 at Stanford University School of Medicine (Palo Alto, CA, USA). Records were reviewed for surgical start time, the presence of vitreoretinal fellow, and postoperative adverse events defined as any finding deviating from the expected postoperative course requiring observation or intervention. Results: A total of 310 pars plana vitrectomies were performed. There was no statistical difference in the rate of any adverse event when comparing cases starting after 16:01 (9/13, 69.2%) and after 12:01 (42/99, 42.4%) to a morning start time (69/198, 34.9%, adjusted p = 0.083). There was a statistically significant increase in the risk of postoperative vitreous hemorrhage with afternoon and evening cases as compared to morning cases (adjusted p = 0.021). In addition, there was no difference in any adverse event with a fellow present (93/244, 38.1%) compared to without (27/66, 40.9%, adjusted p = 0.163). There was a higher risk of postoperative hypotony when a fellow was involved (6.6% vs 0%, p = 0.028), though this difference disappeared after adjusting for confounders (adjusted p = 0.252). There was no difference in the length of surgery with and without a fellow (49 vs 54 min, respectively; p = 0.990). Discussion: Afternoon start time and the presence of a fellow were not independent risk factors for postoperative adverse events.

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Associations between contextual and compositional characteristics of early childcare facilities with health, health behaviours and well-being among young children aged 06 years: protocol for a scoping review

BMJ Open ◽

10.1136/bmjopen-2020-037038 ◽

2020 ◽

Vol 10 (9) ◽

pp. e037038

Author(s):

Jennifer Hilger-Kolb ◽

Sven Schneider ◽

Raphael Herr ◽

Nina Osenbruegge ◽

Stephanie Hoffmann ◽

...

Keyword(s):

Young Children ◽

Scoping Review ◽

Selection Process ◽

Life Stage ◽

Well Being ◽

Primary Data ◽

Cochrane Library ◽

Key Characteristics ◽

Scoping Reviews ◽

Early Childcare

IntroductionEarly childhood is an important life stage which is crucial for determining health and health inequalities in later life. At the meso-level (institutional-level), early childcare facilities (eg, kindergartens, preschools) are the most important agent of socialisation next to families in young children aged 06 years. In recent years, an increasing amount of studies has focused on contextual and compositional characteristics of early childcare facilities and their association with health (eg, self-rated health), health behaviour (eg, physical activity) and well-being (eg, emotional well-being) in this age group. However, as currently no overview of the available literature on this topic exists, we will conduct a scoping review including various study designs (eg, cross-sectional studies, prospective studies, qualitative studies).Methods and analysisWe will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A systematic search of the following scientific databases will be conducted: PubMed/Medline, PsycInfo, Sociological Abstracts, Education Resources Information Center and The Cochrane Library. During the selection process, we will follow a two-step process. First, two reviewers will independently screen titles/abstracts of all potentially eligible articles by applying a set of previously defined inclusion and exclusion criteria. After the completion of the title/abstract screening, full texts of the remaining articles will be screened following the same procedure. To determine inter-rater agreement between reviewers, we will calculate Cohen’s Kappa after both steps. Key characteristics (eg, country of origin, sample size, study design) of included articles will be extracted. We will map the evidence available by providing a summary table on the key characteristics extracted and by presenting the associations using various types of illustrations.Ethics and disseminationSince no primary data will be collected for this review, ethical approval is not required. Our findings will be published in an international peer-reviewed journal and presented at national and international conferences.

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Clinical impact of endoscopic ultrasound-guided through-the-needle microbiopsy in patients with pancreatic cysts

Endoscopy ◽

10.1055/a-1214-6043 ◽

2020 ◽

Vol 53 (01) ◽

pp. 44-52 ◽

Cited By ~ 4

Author(s):

Bojan Kovacevic ◽

Pia Klausen ◽

Charlotte Vestrup Rift ◽

Anders Toxværd ◽

Hanne Grossjohann ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Endoscopic Ultrasound ◽

Clinical Management ◽

Event Rate ◽

Clinical Impact ◽

Adverse Event Rate ◽

Controlled Study ◽

Cystic Neoplasm ◽

Pancreatic Cysts

Abstract Background The limited data on the utility of endoscopic ultrasound (EUS)-guided through-the-needle biopsies (TTNBs) in patients with pancreatic cystic lesions (PCLs) originate mainly from retrospective studies. Our aim was to determine the clinical impact of TTNBs, their added diagnostic value, and the adverse event rate in a prospective setting. Methods This was a prospective, single-center, open-label controlled study. Between February 2018 and August 2019, consecutive patients presenting with a PCL of 15 mm or more and referred for EUS were included. Primary outcome was a change in clinical management of PCLs following TTNB compared with cross-sectional imaging and cytology. Adverse events were defined according to the ASGE lexicon. Results 101 patients were included. TTNBs led to a change in clinical management in 11.9 % of cases (n = 12). Of these, 10 had serous cysts and surveillance was discontinued, while one of the remaining two cases underwent surgery following diagnosis of a mucinous cystic neoplasm. The diagnostic yield of TTNBs for a specific cyst diagnosis was higher compared with FNA cytology (69.3 % vs. 20.8 %, respectively; P < 0.001). The adverse event rate was 9.9 % (n = 10; 95 % confidence interval 5.4 % – 17.3 %), with the most common event being acute pancreatitis (n = 9). Four of the observed adverse events were severe, including one fatal outcome. Conclusions TTNBs resulted in a change of clinical management in about one in every 10 patients; however, the associated adverse event risk was substantial. Further studies are warranted to elucidate in which subgroups of patients the clinical benefit outweighs the risks.

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