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Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India.

ABSTRACT: The study aimed to assess the adverse events following COVID-19 vaccine (Covaxin) immunization at a tertiary care institution and also assess the predictors of the adverse events following immunization (AEFI). The prospective observational study was conducted in a tertiary care institute among the Covaxin beneficiaries between June 28 and September 6, 2021. A total of 1826 participants were assessed for any local or systemic adverse events after seven days of vaccination. A telephonic interview was conducted, and the beneficiaries were assessed according to the adverse event grading. A total of 1826 participants were assessed for AEFI, and 544 (29.8%) reported at least one of the AEFI. No severe adverse events were reported, and about 1.6% had moderate AEFI. Pain at the injection site (14.6%), fever (9.7%), and myalgia (5.9%) were the common adverse events reported by the participants. AEFI incidence was higher in the first dose (38.1%) when compared to the second dose (26.4%), and this finding was significant with a p < 0.001. The major factors associated with AEFI were female sex, history of an allergic reaction, presence of comorbidities, acute infection in the past 3 months, and intake of chronic medications. Precaution needs to be taken while vaccinating individuals having allergies, comorbidities, acute infection in the last 3 months, and individuals on chronic medication.

SUBMITTER: Parida SP

PROVIDER: S-EPMC9088522 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India.

Parida Swayam Pragyan SP Sahu Dinesh Prasad DP Singh Arvind Kumar AK Alekhya G G Subba Sonu Hangma SH Mishra Abhisek A Padhy Biswa Mohan BM Patro Binod Kumar BK

Journal of medical virology 20220221 6

The study aimed to assess the adverse events following COVID-19 vaccine (Covaxin) immunization at a tertiary care institution and also assess the predictors of the adverse events following immunization (AEFI). The prospective observational study was conducted in a tertiary care institute among the Covaxin beneficiaries between June 28 and September 6, 2021. A total of 1826 participants were assessed for any local or systemic adverse events after seven days of vaccination. A telephonic interview ...[more]

PMID: 35149993

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Project description:IntroductionThe rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).ObjectiveThe primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty®, Moderna's Spikevax®, AstraZeneca's Vaxzevria® and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.MethodsPatient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.ResultsData of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.ConclusionsThe analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.

Project description:BackgroundVaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process.MethodsFirst, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM).ResultsOur results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people's vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy.ConclusionsThis paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases.

Project description:BackgroundWith over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.MethodsA case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC's Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system's attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews.ResultsIn all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated "fear of being victimized" as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics.ConclusionThe AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.

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Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India.

Publications

Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India.

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