ASSESS THE ADVERSE DRUG REACTIONS OF VARIOUS COVID VACCINES

Background: Adverse drug reactions (ADRs) following COVID-19 vaccination have been reported globally, but data on their incidence, severity, and associated risk factors remain limited. This study aimed to evaluate the occurrence and characteristics of ADRs among recipients of Covaxin and Covishield vaccines. Methods: A total of 372 participants were enrolled. ADRs were assessed in relation to age, gender, concomitant medications, and clinical manifestations. Causality and severity were evaluated using the WHO-UMC scale and the modified Hartwig and Siegel scale, respectively. Results: Among participants, 62 receiving Covaxin and 267 receiving Covishield experienced ADRs. The majority occurred in the 45–59 years age group (33.77%) and predominantly in males (Covaxin 60.94%, Covishield 71%). Participants on antihypertensive therapy reported the highest incidence of ADRs (43.33%), followed by proton pump inhibitors (15.5%) and hormonal drugs (12.5%). The most common ADRs included severe pain at the injection site (90.8%), weakness (87.54%), fever (87.21%), fatigue (61.9%), joint pain (57.3%), and muscle ache (54.75%). Organ systems most frequently affected were the skin and musculoskeletal system (25.87%) and gastrointestinal system (23.24%). Causality assessment revealed 20.38% probable, 37.54% possible, and 34.62% certain ADRs. According to the modified Hartwig and Siegel scale, 49.25% of ADRs were mild. Conclusion: ADRs following COVID-19 vaccination were common, particularly among middle-aged males and those on antihypertensive therapy. Most ADRs were mild and involved the musculoskeletal and skin systems. These findings highlight the importance of monitoring ADRs and providing guidance for vaccine recipients to manage expected side effects effectively. Keywords: Adverse drug reactions, COVID-19 vaccination, Covaxin, Covishield

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-10-09
DOI
https://doi.org/10.5281/zenodo.17307414
Primary Topic
Intramuscular injections and effects
Type
article
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article

ASSESS THE ADVERSE DRUG REACTIONS OF VARIOUS COVID VACCINES

Zenodo (CERN European Organization for Nuclear Research)
Intramuscular injections and effects
article

ASSESS THE ADVERSE DRUG REACTIONS OF VARIOUS COVID VACCINES

article en

Abstract

Background: Adverse drug reactions (ADRs) following COVID-19 vaccination have been reported globally, but data on their incidence, severity, and associated risk factors remain limited. This study aimed to evaluate the occurrence and characteristics of ADRs among recipients of Covaxin and Covishield vaccines. Methods: A total of 372 participants were enrolled. ADRs were assessed in relation to age, gender, concomitant medications, and clinical manifestations. Causality and severity were evaluated using the WHO-UMC scale and the modified Hartwig and Siegel scale, respectively. Results: Among participants, 62 receiving Covaxin and 267 receiving Covishield experienced ADRs. The majority occurred in the 45–59 years age group (33.77%) and predominantly in males (Covaxin 60.94%, Covishield 71%). Participants on antihypertensive therapy reported the highest incidence of ADRs (43.33%), followed by proton pump inhibitors (15.5%) and hormonal drugs (12.5%). The most common ADRs included severe pain at the injection site (90.8%), weakness (87.54%), fever (87.21%), fatigue (61.9%), joint pain (57.3%), and muscle ache (54.75%). Organ systems most frequently affected were the skin and musculoskeletal system (25.87%) and gastrointestinal system (23.24%). Causality assessment revealed 20.38% probable, 37.54% possible, and 34.62% certain ADRs. According to the modified Hartwig and Siegel scale, 49.25% of ADRs were mild. Conclusion: ADRs following COVID-19 vaccination were common, particularly among middle-aged males and those on antihypertensive therapy. Most ADRs were mild and involved the musculoskeletal and skin systems. These findings highlight the importance of monitoring ADRs and providing guidance for vaccine recipients to manage expected side effects effectively. Keywords: Adverse drug reactions, COVID-19 vaccination, Covaxin, Covishield

Zenodo (CERN European Organization for Nuclear Research)
Good health and well-being
Openalex Percentile: Top 34%
Intramuscular injections and effects
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ASSESS THE ADVERSE DRUG REACTIONS OF VARIOUS COVID VACCINES · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS