scholarly journals Adverse Events Following Immunization to CovId-19 vaccines in A Tertiary Care Hospital – A descriptive Study

2021 ◽  
Vol 14 (4) ◽  
pp. 2149-2156
Author(s):  
Vijaya Chandra Reddy Konda ◽  
Thulasi Gokul ◽  
M Poojitha M Poojitha ◽  
K Umamaheswara Rao
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Active Surveillance ◽  
Tertiary Care ◽  
Age Groups ◽  
Descriptive Study ◽  
Care Hospital ◽  
Limited Data ◽  
Monitoring Centre ◽  
Pharmaceutical Industries

Introduction: The pandemic due to Coronavirus disease 2019 (COVID-19) is a major health issue resulting in mortality across the globe. Multiple newer medications are being tried in treatment but with minimal success. The development of vaccines is occurring with unprecedented speed using different platforms with collaborations of academia and the pharmaceutical industries globally. These vaccines are approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there is a need for active surveillance of vaccine recipients to monitor for safety. Methods: Adverse drug reaction monitoring centre (AMC) of our institute is actively involved in surveillance of recipients for adverse events following immunization (AEFI) who received vaccines for COVID-19 from the vaccination centre of the institute. As per the guidelines of National Coordinating Centre (NCC), Pharmacovigilance Programme of India (PvPI), designated staff of AMC follows up vaccine recipients over their registered mobile number post-vaccination for AEFI if any. This is a descriptive study of all the AEFI reported to NCC, PvPI between 16th January 2021 and 31st March 2021. Results: Of the 5793 doses of vaccination administered during the study period, 59.4% (3443) responded to follow up and 8.6% (299 of 3443) recipients reported 509 AEFI. The most common reported AEFI include fever, generalized body pains, and headache constituting 36.1%, 30.5%, and 18.5% respectively. 64.2% (327 of 509) of AEFI were reported from people younger than 45 years of age. Though females constituted 53.8% (161 of 299) of people who reported AEFI, total number of events reported from this group was 58% (295 of 509). More number of AEFI were observed after first dose of COVISHIELD compared to second dose. Conclusion: COVID-19 vaccination drive is rolled out in multiple phases for different age groups across the country. Many vaccinations are being approved for use in general public with limited data from clinical trials. Active surveillance of COVID-19 vaccines for AEFI helps us in further understanding safety issues beyond the clinical trial environment.

scholarly journals Serious adverse events reported from the COVID-19 vaccines: A descriptive study based on WHO database

2021 ◽  
Author(s):  
Siddhartha Dutta ◽  
Rimple Jeet Kaur ◽  
Jaykaran Charan ◽  
Pankaj Bhardwaj ◽  
Praveen Sharma ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Age Groups ◽  
Descriptive Study ◽  
Causality Analysis ◽  
Limited Data ◽  
Serious Adverse Events ◽  
Short Period ◽  
The Individual ◽  
System Organ

Background: In the light of the current pandemic, the emergency approval of few COVID-19 vaccines seems to provide a ray of hope. However, their approval is solely based on limited data available from the clinical trials in a short period of time; thereby imposing a necessity to study the adverse events (AEs) associated with their use. This study therefore aims to assess the Serious Adverse Events (SAEs) associated with various COVID 19 vaccines reported in the WHO database (VigiBase). Methods: The data from VigiBase was analyzed to assess the reported SAEs linked to various COVID 19 vaccines. The duplicates in the data were removed and were analyzed on the basis of age, gender, and seriousness of adverse events at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level. Results: A total 103954 adverse events reported from 32044 subjects were taken for analysis. Of 32044 subjects, majority were females (80%). Also, a total of 28799 (27.7%) SAEs were reported from the 8007 individuals. Most of the SAEs were reported from Europe (83%), amongst females (79.4%) and between 18 to 64 years (80.74%) of age. Majority of SAEs (74%) were reported for BNT162b2 (Pfizer) vaccine. On system wise classification, general disorders (30%) were the commonest followed by nervous system (19.1%) and musculoskeletal (11.2%) disorders. In individual category, headache (8.1%) was the commonest, followed by pyrexia (7%) and fatigue (5.1%). The number of SAEs were reported with various vaccines were comparatively lesser as compared to the non-serious ones and incidence of death was low with all the vaccines candidates. Elderly (> 65 years) people reported more serious SAEs as compared to other age groups. Conclusion: The reported SAEs from the COVID 19 vaccines were in line with the data published in clinical trials. To link these SAEs to vaccines will need causality analysis and review of individual reports.

scholarly journals 817. Appropriate Sites for the Active Surveillance of Carbapenemase-producing Enterobacteriaceae

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S501-S502
Author(s):  
Joung Ha Park ◽  
Hye-Suk Choi ◽  
Hyejin Yang ◽  
Hyun-Ju Lee ◽  
Sun Hee Kwak ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Surgical Intensive Care Unit ◽  
Study Cohort ◽  
Care Hospital ◽  
Negative Group ◽  
Limited Data ◽  
Surgical Intensive Care ◽  
Transmission Rates

Abstract Background Active surveillance tests for carbapenemase-producing Enterobacteriaceae (CPE) are recommended in patients showing risk factors for colonization by these bacteria. There are limited data however on whether surveillance tests for anatomic sites other than the stool would be useful to detect CPE colonization, and we investigated this in our present study. Methods Retrospective analysis was performed on cases at our tertiary care hospital during a 5-year period. The study patients with CPE colonization had been admitted to our surgical intensive care unit (SICU) or sub-ICU for liver transplantation in this period and undergone surveillance tests for both the stool and other sites. Patients were grouped as stool CPE negative (but which included CPE positive cases from initial sputum and other site tests) or positive. Results Among the total study cohort of 158 patients, 138 (87.3%) were included in the stool CPE positive group and the remaining 20 (12.7%) in the stool CPE negative group. While the sensitivity of CPE surveillance testing of the stool was 87.3% (95% CI 81.1-92.1), the sensitivity when combining stool and sputum samples was 93.7% (88.7-96.9). The transmission rates were similar for patients showing CPE positivity in the stool, sputum and other sites, at 4.8% (27/557), 4.7% (3/64), and 6.7% (1/15), respectively (p = 0.95). Conclusion The sensitivity of CPE detection in a stool sample is suboptimal for ruling out CPE colonization and the transmission rates are similar between stool-positive or -negative cases. Combining surveillance of the stool with other sites may be needed for detecting CPE. Disclosures All Authors: No reported disclosures

scholarly journals Appropriate sites for the active surveillance of carbapenemase-producing Enterobacteriaceae

2021 ◽  
Author(s):  
Joung Ha Park ◽  
Hye-Suk Choi ◽  
Hyejin Yang ◽  
Hyun-Ju Lee ◽  
Sun Hee Kwak ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Surgical Intensive Care Unit ◽  
Study Cohort ◽  
Care Hospital ◽  
Negative Group ◽  
Limited Data ◽  
Surgical Intensive Care ◽  
Transmission Rates

Abstract Background: Active surveillance tests for carbapenemase-producing Enterobacteriaceae (CPE) are recommended in patients showing risk factors for colonization by these bacteria. There are limited data however on whether surveillance tests for anatomic sites other than the stool would be useful to detect CPE colonization, and we investigated this in our present study.Methods: Retrospective analysis was performed on cases at our tertiary care hospital during a 5-year period. Patients with CPE colonization had been admitted to our surgical intensive care unit (SICU) or sub-ICU for liver transplantation in this period and undergone surveillance tests for both the stool and other sites. Patients were grouped as stool CPE negative (but which included CPE positive cases from initial sputum and other site tests) or positive. Results: Among the total study cohort of 158 patients, 138 (87.3%) were included in the stool CPE positive group and the remaining 20 (12.7%) in the stool CPE negative group. While the sensitivity of CPE surveillance testing of the stool was 87.3% (95% CI 81.1-92.1), the sensitivity when combining stool and sputum samples was 93.7% (88.7-96.9). The transmission rates were similar for patients showing CPE positivity in the stool, sputum and other sites, at 4.8% (27/557), 4.7% (3/64), and 6.7% (1/15), respectively (p = 0.95).Conclusions: The sensitivity of CPE detection in a stool sample is suboptimal for ruling out CPE colonization and the transmission rates are similar between stool-positive or -negative cases. Thus, combining surveillance of the stool with other sites may be needed for detecting CPE.

Seroprevalence of anti-SARS-CoV-2 IgG antibodies in hospitalized patients at a tertiary referral center in North India (Preprint)

2020 ◽  
Author(s):  
Dr. Animesh Ray ◽  
Dr. Komal Singh ◽  
Souvick Chattopadhyay ◽  
Farha Mehdi ◽  
Dr. Gaurav Batra ◽  
...  
Keyword(s):  
Tertiary Care ◽  
Age Groups ◽  
Hospitalized Patients ◽  
North India ◽  
P Value ◽  
Care Hospital ◽  
Igg Antibodies ◽  
Igg Antibody ◽  
Increased Risk ◽  
Significant Difference

BACKGROUND Seroprevalence of IgG antibodies against SARS-CoV-2 is an important tool to estimate the true extent of infection in a population. However, seroprevalence studies have been scarce in South East Asia including India, which, as of now, carries the third largest burden of confirmed cases in the world. The present study aimed to estimate the seroprevalence of anti-SARS-CoV-2 IgG antibody among hospitalized patients at one of the largest government hospital in India OBJECTIVE The primary objective of this study is to estimate the seroprevalence of SARS-CoV-2 antibody among patients admitted to the Medicine ward and ICU METHODS This cross-sectional study, conducted at a tertiary care hospital in North India, recruited consecutive patients who were negative for SARS-CoV-2 by RT-PCR or CB-NAAT. Anti-SARS-CoV-2 IgG antibody levels targeting recombinant spike receptor-binding domain (RBD) protein of SARS CoV-2 were estimated in serum sample by the ELISA method RESULTS A total of 212 hospitalized patients were recruited in the study with mean age (±SD) of 41.2 (±15.4) years and 55% male population. Positive serology against SARS CoV-2 was detected in 19.8%patients(95% CI 14.7-25.8). Residency in Delhi conferred a higher frequency of seropositivity 26.5% (95% CI 19.3-34.7) as compared to that of other states 8% (95% CI 3.0-16.4) with p-value 0.001. No particular age groups or socio-economic strata showed a higher proportion of seropositivity CONCLUSIONS Around, one-fifth of hospitalized patients, who were not diagnosed with COVID-19 before, demonstrated seropositivity against SARS-CoV-2. While there was no significant difference in the different age groups and socio-economic classes; residence in Delhi was associated with increased risk (relative risk of 3.62, 95% CI 1.59-8.21)

scholarly journals ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

2018 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil
Keyword(s):  
Prospective Study ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Organ Systems ◽  
A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

scholarly journals Steroid-induced Rosacea- A Study From a Tertiary Care Hospital of Eastern Nepal

2021 ◽  
Vol 19 (1) ◽  
pp. 25-29
Author(s):  
Manoj Chaudhary ◽  
Sudha Agrawal
Keyword(s):  
Tertiary Care ◽  
Age Groups ◽  
Case Series ◽  
Sun Exposure ◽  
Care Hospital ◽  
Facial Erythema ◽  
Case Series Study ◽  
The Face ◽  
Triggering Factor ◽  
Study Population

Introduction: Topical corticosteroids (TC) are useful for treatment of various dermatological conditions in all age groups. Due to its cosmetic application TCs misuse is intertwined with fairness creams in our colour conscious society where people are obsessed with fair colour.   Aims and Objectives: To find the clinical presentations of steroid induced rosacea like-dermatitis on the face and to evaluate the purpose behind misusing TCs on the face.   Materials and methods: Descriptive prospective questionnaire-type case series study was approved by Institutional Ethical Committee of BPKIHS which involved 205 patients diagnosed as Steroid Induced Rosacea who consulted Dermatology OPD between March to June 2017.   Results: Among 205 patients enrolled, majority were from second to fourth decade (87.31%) of their life and maximum being females I.e. 91.2%. Around 97% of the study population were unaware of side effects of TCs. Most patients use Mometasone fuorate (58.04%) for melisma (88.29%). Friends acted as source of prescription (29.75%), followed by Pharmacist (24.88%) & Beauty centers (20%). Dermatologists prescribed TCs in only 6.34% cases. Sun exposure was identified as the triggering factor for steroid induced rosacea in 73.17% patients. Cheek was the commonest site involve in 92.19%, followed by forehead (65.36%), perioral area (46.83%), and chin (9.75%). Mixed type of lesions was the commonest lesion found in 52.20% patients, followed by diffuse facial erythema (36.09%), & telangiectasia (33.17%).   Conclusion: TCs misuse in the younger people for the sake of fairer skin with little or no knowledge about the adverse effects of this medication should be stopped.

scholarly journals Adverse events following immunization with pentavalent vaccine in a tertiary care hospital

2017 ◽  
Vol 5 (1) ◽  
pp. 82
Author(s):  
Sharad Bansal
Keyword(s):  
Adverse Events ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cost Effective ◽  
Care Hospital ◽  
Immunization Programs ◽  
Global Alliance ◽  
Immunization Program ◽  
Pentavalent Vaccine ◽  
Mild Fever

Background: Immunizations currently save 3 million lives per year throughout the world and is one of the most cost-effective health interventions. The Global Alliance for Vaccines and Immunizations (GAVI) and WHO recommended the use of pentavalent to replace the DPT vaccine in developing countries. Vaccines related most side effects are mild and non-serious. Surveillance of adverse events following immunization will enable us to monitor the safety of immunization programs and thereby contribute to validating the immunization program. The main aim of this study is to analyze all suspected adverse events in children reported for pentavalent vaccination.Methods:A prospective, observational epidemiological study was conducted in the department of Paediatrics OPD at tertiary care teaching institute during October 2016 to December 2016. The study was conducted amongst 190 children attending the department of Paediatrics OPD for the second or third dose of pentavalent vaccine.Results: The study shows the following adverse effects after pentavalent injection  127 (66.8%) children had pain at the site of injection, 103(54.2%) mild fever, Swelling at injection site 84(44.2%) and 55(28.9%) children held their leg back due to pain. In majority 85 (44.7%) of children antipyretic and in 65 (34.2%) children analgesic was given was given to relieve the symptoms. The parents were very positive for completing their children’s immunization schedule even though they have faced few symptoms.Conclusions:It can be concluded that all the adverse events reported were mild and could be managed easily without any complications. 

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