Incidence of adverse events following immunization (AEFI) among infants after immunization with primary doses of scheduled vaccines in district Srinagar (J&K)

Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. However, like other medicinal products, vaccines are not free from adverse reactions. AEFI is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The reporting of AEFI’s from the routine system is inadequate due to many reasons. Hence this study was conducted to throw some light and provide the baseline data. To find out the incidence of adverse events following immunization among infants in District Srinagar. It was a prospective study in which parents of infants receiving vaccines were contacted telephonically after specified time intervals to verify the occurrence of adverse events. The children were followed till 30 days of the administration of vaccines up to measles rubella vaccine. The incidence of AEFI reported in this study was 23.03% with 95% CI (22.24% to 23.85%). The most frequently reported AEFI was Fever (54.90%, n=1322), followed by Diarrhea (8.30%, n=200) and Vomiting (8.14%, n=196). AEFI were more in frequency during first week of receiving vaccine and most of the parents of children did not report AEFI after 7 days after vaccination. This study reveals that most of the vaccines associated adverse reactions were of mild and non-serious type and rarely of serious nature, yet proper monitoring of vaccine associated adverse reactions; is too essential. Proper and complete reporting of AEFI’s by field workers needs to be encouraged.

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Efficacy of an Oxycodone-Propofol Combination versus a Fentanyl-Propofol Combination in Conscious Sedation during Therapeutic Endoscopic Retrograde Cholangiopancreatography in Elderly Patients

Gerontology ◽

10.1159/000511173 ◽

2020 ◽

pp. 1-8

Author(s):

Peipei Guo ◽

Huisheng Wu ◽

Lan Liu ◽

Qiu Zhao ◽

Zhao Jin

Keyword(s):

Adverse Events ◽

Elderly Patients ◽

Endoscopic Retrograde Cholangiopancreatography ◽

Postoperative Nausea ◽

Recovery Time ◽

Adverse Reactions ◽

Conscious Sedation ◽

Endoscopic Retrograde ◽

Patients Satisfaction ◽

Low Incidence

Background: With a rapidly aging population, the need for endoscopic retrograde cholangiopancreatography (ERCP) is increasing. The commonly used sedation anesthesia in ERCP is a combination of propofol and fentanyl, even though fentanyl may cause some adverse reactions such as respiratory depression. Objectives: This study aimed to evaluate the efficacy of oxycodone combined with propofol versus fentanyl combined with propofol for sedation anesthesia during ERCP. Methods: A total of 193 patients aged from 65 to 80 years undergoing ERCP were enrolled and randomized into two groups: an “oxycodone combined with propofol” group (group OP, n = 97) and a “fentanyl combined with propofol” group (group FP, n = 96). The rate of perioperative adverse events as well as the recovery time, patients’ satisfaction, and endoscopists’ satisfaction were noted. Results: There was no difference in the frequency of hypotension or bradycardia between the two groups, but there were more episodes of desaturation (SpO2 <90% for >10 s in 8.3%), postoperative nausea (7.3%), and vomiting (5.2%) in group FP than in group OP. Patients’ satisfaction in group FP was lower than that in group OP. The recovery time was longer in group FP than in group OP. Conclusions: Oxycodone combined with propofol was effective in ERCP, with a low incidence of perioperative adverse events.

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Adverse reactions to oxacillin in hospitalized children: a prospective study

Revista Brasileira de Saúde Materno Infantil ◽

10.1590/s1519-38292007000100007 ◽

2007 ◽

Vol 7 (1) ◽

pp. 55-61 ◽

Cited By ~ 1

Author(s):

Mariana de Oliveira Brizeno de Souza ◽

Maria da Conceição Castro de Araújo ◽

Raquel Araújo de Santiago ◽

Helena Lutéscia Luna Coelho ◽

Marta Maria de França Fonteles

Keyword(s):

Exposure Time ◽

Treatment Duration ◽

Adverse Reactions ◽

Therapeutic Interventions ◽

Hospitalized Children ◽

Significant Relation ◽

Moderate Severity ◽

A Prospective Study ◽

Established Treatment

OBJECTIVES: follow-up of children exposed to oxacillin during hospitalization focusing on adverse reactions. METHODS: patients were selected from the pediatric wards of two hospitals in Fortaleza (Hospital Universitário Walter Cantídio-HUWC and Hospital Infantil Albert Sabin-HIAS) from the first oxacillin prescription with a prospective cohort study between October, 2000 and July, 2001 (HUWC) and July/2001 and March, 2002 (HIAS). Patients' follow-up was performed by daily visits to the wards and medical charts and prescription analysis. Suspected oxacillininduced adverse reactions (OxAR cases) were notified and classified according to causality and severity. Related statistic tests were completed. RESULTS: of the 130 patients exposed to oxacillin, 27 had OxAR (20.8%). Fever was the most frequent reaction (50%) followed by rash (35.7%). The majority of reactions were considered Probable, for oxacillin was the only medication involved and 92.6% of the cases had Moderate severity with the need of therapeutic interventions caused by OxAR. A significant relation between oxacillin exposure time and OxAR was determined as well as hospitalization time and the appearance of adverse reactions. Exposure time over 14 days to oxacillin was established as a risk factor for OxAR (relative risk = 5.49). CONCLUSIONS: careful administration of oxacillin in children is recommended with established treatment duration. Empiric and prolonged use must be avoided.

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AB0864 DO CORTICOSTEROIDS AND HYALURONIC ACID INJECTIONS CAUSE INFECTIONS? A SYSTEMATIC REVIEW OF LITERATURE ON ADVERSE EFFECTS AND INFECTION RATES OF INTRA-ARTICULAR CORTICOSTEROID AND HYALURONIC ACID INJECTIONS IN PATIENTS WITH KNEE OSTEOARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5799 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1739.2-1739

Author(s):

C. Hatzantonis

Keyword(s):

Systematic Review ◽

Hyaluronic Acid ◽

Adverse Effects ◽

Adverse Events ◽

Knee Osteoarthritis ◽

Adverse Reactions ◽

Infection Rates ◽

Management Options ◽

Cochrane Reviews ◽

Number Of Patients

Background:Knee osteoarthritis has been a leading cause of chronic pain and disability in our increasingly aging population. Conservative management options of physiotherapy and oral analgesics offer some relief, but delivery of intra-articular injections such as corticosteroids or hyaluronic acid has increasingly become the mainstay of pain management of knee osteoarthritis. In a clinical setting, intra-articular injections offer a means to delay a total knee replacement. Despite the abundance of literature on corticosteroids and hyaluronic acid, there is no known percentage of infection rates or adverse effects that clinicians may use to inform patients prior to obtaining consent for the injection.Objectives:To determine a rate of adverse events and infection rates in patients undergoing intra-articular injections of corticosteroids or hyaluronic acid.Methods:A systematic review of current literature including studies involving patients ranging from 45 patients (Carmona L, 2018) to Cochrane reviews of 1767 patients (Campbell Kirk, 2015). From these studies, the number of patients, adverse reactions (i.e. pain, erythema) and serious adverse reactions (infections) were calculated.Results:Within our study, there was a large variation of numbers of adverse effects of hyaluronic acid and corticosteroids amongst studies, with percentages as variable as 0-9.3%. Corticosteroids demonstrated 11-26% reduction of adverse events compared to hyaluronic acid. However, confidence intervals were found to not be statistically significant.Conclusion:Intra-articular injections of corticosteroids and hyaluronic acid, although deemed clinically effective, continue to demonstrate variable rates of adverse effects and infection amongst patients with progressive knee osteoarthritis.Disclosure of Interests:None declared

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First, do no harm: the risks of overtreating children with epilepsy

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2007000100002 ◽

2007 ◽

Vol 65 (1) ◽

pp. 1-4 ◽

Cited By ~ 1

Author(s):

Eunice Chuang ◽

Marilisa M. Guerreiro ◽

Sara Y. Tsuchie ◽

Angelica Santucci ◽

Carlos A. M. Guerreiro ◽

...

Keyword(s):

Adverse Events ◽

Prospective Study ◽

Antiepileptic Drug ◽

Antiepileptic Drugs ◽

Seizure Frequency ◽

Seizure Control ◽

Control Method ◽

Refractory Epilepsy ◽

Do No Harm ◽

A Prospective Study

BACKGROUND: Although overtreatment with antiepileptic drugs contributes to the morbidity associated with epilepsy, many children still are overtreated. OBJECTIVE: To evaluate if the withdrawal of at least one antiepileptic drug (AED) in children with refractory epilepsy using polytherapy enable a better seizure control. METHOD: This was a prospective study. Children with refractory epilepsy using at least two AEDs were included. Once the patient, or guardian, agreed to participate in the study, one or more AED were slowly tapered off. The remaining AEDs dosages could be adjusted as needed, but a new AED could not be introduced. RESULTS: Fifteen patients were evaluated, three girls; ages ranging from 3 to 18 (mean=8.7 years). After at least one AED withdrawal, two (13.5%) patients became seizure free, seizures improved >50% in 5 (33.5%) patients, did not change in 5 (33.5%), and seizure frequency became worse in 3 (20%). Adverse events improved in 12 patients (80%). CONCLUSION: The withdrawal of at least one AED is a valuable option in the treatment of selected children with refractory epilepsy.

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Factors affecting vascular access complications in children undergoing congenital cardiac catheterization

Cardiology in the Young ◽

10.1017/s1047951111000989 ◽

2011 ◽

Vol 22 (2) ◽

pp. 136-144 ◽

Cited By ~ 10

Author(s):

Alaa M. Roushdy ◽

Noha Abdelmonem ◽

Azza A. El Fiky

Keyword(s):

Body Weight ◽

Adverse Events ◽

Cardiac Catheterization ◽

Vascular Access ◽

Vascular Complications ◽

P Value ◽

Factors Affecting ◽

Vein Thrombosis ◽

Access Complications ◽

A Prospective Study

AbstractBackgroundComplications at the vascular access sites are among the most common adverse events in congenital cardiac catheterization. The use of small-gauge catheters may reduce these events; however, other factors can contribute to the development of vascular complications.ObjectivesTo determine factors associated with the development of vascular access complications in children undergoing congenital cardiac catheterization.MethodsWe performed a prospective study of 403 patients who underwent diagnostic (62.5%) or interventional (37.5%) cardiac catheterization over a period of 6 months, and analysed the vascular complications during and immediately after the procedure.ResultsThe most common access-related adverse event was transient loss of pulsation (17.6%). Other less common access-related adverse events included subcutaneous haematoma (2%), bleeding (3%), vessel tear (0.2%), and vein thrombosis (0.2%). Patients who had no access-related adverse events had significantly higher age and body weight compared with those who had one or more access problems. Among 81 patients who had vascular access established in unplanned access sites, 30 patients (37%) had lost pulsations. Among the 322 patients who had vascular access established in planned access sites, however, only 41 patients had lost pulsation (13%). In addition, patients who had lost pulsations had significantly longer puncture time compared to those who had normal pulsations (p value 0.01).ConclusionFactors other than sheath size can contribute to access-related adverse events in children undergoing cardiac catheterization. Obtaining vascular access in unplanned access sites and longer puncture times increases the incidence of lost pulsations after catheterization. Younger age and smaller body weight are also associated with significant increase in access-related adverse events.

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Rheumatological Adverse Events Following Immunotherapy for Cancer

Medicina ◽

10.3390/medicina58010094 ◽

2022 ◽

Vol 58 (1) ◽

pp. 94

Author(s):

Ioana Cretu ◽

Bogdan Cretu ◽

Catalin Cirstoiu ◽

Adrian Cursaru ◽

Mihaela Milicescu ◽

...

Keyword(s):

Side Effects ◽

Adverse Events ◽

Adverse Reactions ◽

Cancer Treatments ◽

Treatment Conditions ◽

Clinical Presentations ◽

Rheumatic Manifestations ◽

Grade 3 ◽

Dose Dependent ◽

Rheumatological Manifestations

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1–2) were reported in a higher proportion than severe side effects (grade 3–5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

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Papulopustular rash following Moderna COVID-19 (mRNA-1273) vaccine: A case report

Journal of Skin and Sexually Transmitted Diseases ◽

10.25259/jsstd_85_2021 ◽

2022 ◽

Vol 0 ◽

pp. 1-5

Author(s):

David Pudukadan

Keyword(s):

Case Report ◽

Adverse Events ◽

Adverse Reactions ◽

Healthcare Professionals ◽

Systemic Steroids ◽

Effective Care ◽

Short Course ◽

The World

Coronavirus disease-2019 (COVID-19) has affected countries around the world. The introduction of COVID-19 vaccines has proved the most effective arsenal in the fight against the disease. However, with the vaccination of billions of people, data on vaccine-induced adverse reactions are also emerging. We report a 32-year-old woman who manifested papulopustular rash 7 days after receiving Moderna COVID-19 (mRNA-1273) vaccine. The patient responded to a short course of systemic steroids and antihistamines. Awareness regarding the possible adverse events that can be anticipated after the COVID-19 vaccination may help the healthcare professionals to offer prompt and effective care to the affected.

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Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

Safety and Risk of Pharmacotherapy ◽

10.30895/2312-7821-2021-9-1-34-42 ◽

2021 ◽

Vol 9 (1) ◽

pp. 34-42

Author(s):

E. Yu. Demchenkova ◽

G. I. Gorodetskaya ◽

I. A. Mazerkina ◽

M. V. Zhuravleva ◽

A. S. Kazakov ◽

...

Keyword(s):

Adverse Events ◽

Adverse Drug Reactions ◽

Patient Information ◽

Adverse Reactions ◽

Stevens Johnson Syndrome ◽

Drug Reactions ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Spontaneous Reports ◽

Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

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A phase I/II trial to treat massive Africanized honeybee (Apis mellifera) stings using the new apilic antivenom

10.1101/2020.12.26.20248062 ◽

2021 ◽

Author(s):

Alexandre Naime Barbosa ◽

Rui Seabra Ferreira ◽

Francilene Capel Tavares de Carvalho ◽

Fabiana Schuelter-Trevisol ◽

Mônica Bannwart Mendes ◽

...

Keyword(s):

Mass Spectrometry ◽

Apis Mellifera ◽

Adverse Events ◽

Phase I ◽

Adverse Reactions ◽

Median Number ◽

Treatment Schedule ◽

Africanized Honeybee ◽

Hospitalization Period ◽

Safety Endpoint

ABSTRACTSafety, optimal minimum dose, and, preliminary effectiveness of a new generation Africanized honeybees (Apis mellifera) antivenom (AAV) were evaluated. A phase I/II, multicenter, non- randomized, single-arm clinical trial involving 20 participants showing multiple stings were studied. Participants have received either 2 to 10 vials of AAV based on the stings number together with a predefined adjuvant, symptomatic, and complementary treatment schedule. The primary safety endpoint was the presence of early adverse reactions within the first 24 hours after treatment. Preliminary efficacy through clinical evolution, including laboratory tests, was assessed at baseline and over the following four weeks. ELISA assays and mass spectrometry estimated the venom pharmacokinetics before, during, and after treatment. Twenty adult participants, 13 (65%) males, and 7 (35%) females, with a median age of 44 years and a mean body surface of 1.92 m2 (median = 1.93 m2) were recruited. The median number of stings was 52.5 ranging from 7 to more than 2,000. Envenoming severity was classified as 80% mild, 15% moderate, and 5% severe. According to the protocol, 16 (80%) participants received two AAV vials, 3 (15%) six vials, and one (5%) 10 vials. There was no discontinuation of the treatment due to acute adverse events and there were no late adverse reactions. Two patients showed mild adverse events with only transient itchy skin and erythroderma. All participants completed the infusion within two hours and there was no loss of follow-up after discharge. ELISA assays showed venom concentrations varying between 0.25 ng/mL and 1.479 ng/mL prior to treatment. Venom levels decreased in all cases during the hospitalization period. Surprisingly, in nine cases (45%), despite clinical recovery and without symptoms, the venom levels increased again during outpatient care 10 days after discharge. Mass spectrometry showed melittin in eight participants 30 days after the treatment. Considering the promising safety results of the investigational product for the treatment of massive Africanized honeybee attacks, added to efficacy in clinical improvement and immediate decrease in blood venom level, the AAV has shown to be safe for human use.Trial registrationUniversal Trial Number (UTN): U1111-1160-7011, Register Number: RBR-3fthf8 (http://www.ensaiosclinicos.gov.br/rg/RBR-3fthf8/).

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Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Archives of Medical Science ◽

10.5114/aoms/133716 ◽

2021 ◽

Author(s):

Maciej Banach ◽

Niki Katsiki ◽

Gustavs Latkovskis ◽

Manfredi Rizzo ◽

Daniel Pella ◽

...

Keyword(s):

Adverse Events ◽

Adverse Reactions ◽

Case Reports ◽

Food Supplement ◽

Product Line ◽

Food Supplements ◽

Red Yeast Rice ◽

Red Yeast ◽

Consumer Safety ◽

Suspected Adverse Reactions

IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labeling.

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