Safety Surveillance of Covishield Vaccine-Associated Adverse Events During the COVID-19 Pandemic: A Retrospective Longitudinal Study.

Autor:	Chaudhary S; Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, IND.; Pharmacology/Pharmacovigilance, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, IND., Aggarwal M; Pharmacology, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, IND., Kumari P; Pharmacology, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, IND., Vishwas G; Clinical Medicine, Indian Council of Medical Research - Rajendra Memorial Research Institute of Medical Sciences (ICMR-RMRIMS), Patna, IND., Meshram GG; Pharmacology, Maulana Azad Medical College, New Delhi, IND., Dhaka R; Community Medicine, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, IND., Garg M; Drug Regulatory Affairs, Delhi Pharmaceutical Sciences and Research University, New Delhi, IND.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Aug 19; Vol. 16 (8), pp. e67257. Date of Electronic Publication: 2024 Aug 19 (Print Publication: 2024).
DOI:	10.7759/cureus.67257
Abstrakt:	Background: Adverse events following immunization (AEFI) must be reported and assessed to promote patient safety. This longitudinal study examined the nature and severity of adverse events reported after Covishield (Serum Institute of India, Pune, India) vaccine administration to North Indians in a tertiary care hospital. Method: A retrospective evaluation of adverse drug reactions (ADRs) reported after Covishield vaccine administration in our hospital over 18 months was conducted. The assessment was carried out to analyze the pattern of ADRs reported by individuals receiving the Covishield vaccine from January 2021 to June 2022. Data such as age, gender, category, dose administered, type of ADR, duration of the event, medical history, and outcome of the reactions were collected. Each reported adverse event was assessed individually. Causality was determined using the WHO-UMC causality assessment scale. The data were analyzed and are expressed as mean ± standard deviation and percentage. Results: A total of 14,590 individuals were vaccinated at our study center from January 2021 to June 2022. During this period, 146 AEFIs (1.0%) were reported at our ADR monitoring center, Employees' State Insurance Corporation Medical College and Hospital (ESIC MCH), Faridabad, India. The majority of AEFIs were systemic, were reported after the first dose, and had an onset within 12 hours after vaccination. Fever, injection site pain, drowsiness, headache, vomiting, swelling, tenderness, and body aches were the most commonly reported adverse effects. No significant relationships were observed between the administered vaccine dose and sex, severity, duration of the event, or outcome. However, the incidence of adverse events was greater with the first vaccine dose than with the second dose. The possibility of serious or fatal adverse events was lowest in the general population and higher in the elderly with comorbidities. Conclusion: The data suggest that the Covishield vaccine had mild to moderate adverse effects on the study population. This pharmacovigilance study will complement safety data and aid in the benefit-risk analysis of adverse effects associated with the Covishield vaccine. Additionally, healthcare professionals should be encouraged to conduct further safety studies by establishing robust vaccine safety monitoring systems in hospitals. Continuing medical education and workshops should also be conducted to educate healthcare workers about active surveillance. Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, India issued approval 134X/11/13/2022-IEC/05. This was a retrospective study conducted by collecting data during routine ADR monitoring at the study site, so patient consent was waived. All study records were kept confidential at our ADR monitoring center, and the identities of the participants were not revealed in any unauthorized manner. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Chaudhary et al.)
Databáze:	MEDLINE
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