ArticleEClinicalMedicine2021
A prospective observational safety study on ChAdOx1 nCoV-19 corona virus vaccine (recombinant) use in healthcare workers- first results from India.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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Who cites it
42 citing papers in PubMed, 76 citations in OpenAlex.
- Article
- Comparison of Transient and Persistent Adverse Events After COVID-19 Vaccination: A Retrospective Analysis.Cureus · 2024Article
- Adverse events following Covaxin administration among adolescents (15-18 years) - A pharmacovigilance study in a district in Northern India.Journal of family medicine and primary care · 2024Article
- Evaluation of SARS-CoV-2 anti-Spike antibody levels and breakthrough infection risk among vaccinated adults in North Lebanon.PloS one · 2024Article
- Adverse events following immunization of ChAdOx1 nCoV-19 vaccine among healthcare workers of a medicine-teaching institution of North India.Journal of family medicine and primary care · 2024Article
- Group of longitudinal adverse event patterns after the fourth dose of COVID-19 vaccination with a latent class analysis.Frontiers in public health · 2024Article
- Adverse events following COVID-19 vaccination: A comprehensive analysis of spontaneous reporting data in Ghana.PLOS global public health · 2024Article
- AstraZeneca COVID-19 Vaccine and Diabetes Mellitus: A Prospective Clinical Study Regarding Vaccine Side Effects.Cureus · 2024Article
- Self-reported side effects of COVID-19 vaccines among health professions students in India.PeerJ · 2024Article
- Did COVID-19 or COVID-19 Vaccines Influence the Patterns of Dengue in 2021? An Exploratory Analysis of Two Observational Studies from North India.The American journal of tropical medicine and hygiene · 2023Article
- Article
- Observational
- Article
- Risks of Cardiac Arrhythmia Associated with COVID-19 Vaccination: A Systematic Review and Meta-Analysis.Vaccines · 2023Review
- Active surveillance of adverse events following COVID-19 vaccines in a tertiary care hospital.Therapeutic advances in vaccines and immunotherapy · 2023Article
- Evaluation of Short-Term Side Effects Following the First Dose of COVID-19 Vaccines Among Physicians and Dentists: A Cross-Sectional Study from India.Journal of multidisciplinary healthcare · 2023Article
- Adverse events associated with Covishield vaccination among healthcare workers in a tertiary hospital in South India.Vaccine: X · 2022Article
- Determinants of COVID-19 Breakthrough Infections and Severity in ChAdOx1 nCoV-19-Vaccinated Priority Groups.The American journal of tropical medicine and hygiene · 2022Observational
- Observational
- Factors associated with development of adverse events after taking COVID-19 vaccine in a tribal state of India: Regression analysis.Journal of family medicine and primary care · 2022Article
Corrections and comments
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Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe provide the first post-approval safety analysis of COVISHIELD in health care workers (HCWs) in northern India.
methodsThis continuing prospective observational study (February 2021 to May 2022) enrolled participants ≥18 years receiving COVISHIELD vaccination. Primary outcome was safety and reactogenicity. Categories (FDA toxicity grading) and outcomes of adverse events following immunization (AEFIs) were recorded, causality assessment performed, and risk factors analysed.
findingsWe present the results of an interim analysis of 804 participants. AEFIs following first dose were reported in 321 (40%; systemic involvement in 248). Among 730 participants who completed a 7-day follow-up post second dose, AEFIs occurred in 115 (15.7%; systemic in 99). Majority of AEFIs were mild-moderate and resolved spontaneously. Serious AEFIs, leading to hospitalization was noticed in 1 (0.1%) participant with suspicion of immunization stress related response (ISRR). AEFIs of grade 3 severity (FDA) were recorded in 4 participants (0.5%). No deaths were recorded. Regression analysis showed increased risk of AEFIs in younger individuals, a two times higher odds in females, those with hypertension or with history of allergy; and three times higher odds in individuals with hypothyroidism.
interpretationCOVISHIELD carries an overall favourable safety profile with AEFI rates much less than reported for other adenoviral vaccines. Females, those with hypertension, individuals with history of allergy and hypothyroidism may need watchful vaccine administration. This being an interim analysis and based on healthcare workers who may not reflect the general population demographics, larger inclusive studies are warranted for confirming the findings.
fundingNo funding support.
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