RESUMO
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.
RESUMO
Albizia lebbeck Benth. is extensively used in Indian traditional medicine for treating several painful and inflammatory disorders. The possible central analgesic activity and the underlying mechanism of action of the aqueous (AE) and ethanolic extracts (EE) of the leaves of A. lebbeck were investigated in Wistar rats using Eddy's hot plate and the tail flick tests. In order to investigate the underlying mechanism of action, rats were pretreated with naloxone, bicuculline or methysergide and then were administered a per os (p.o.) dose of AE or EE. AE and EE caused a significant (p<0.05) elevation in the mean basal reaction time in the hot plate method and an increase in the latency time in the tail flick method. In rats pretreated with bicuculline and methysergide, a significant (p<0.05) reduction in the analgesic activity was observed in comparison to AE and EE. Thus, AE and EE exhibited significant central analgesic activity and act possibly via the GABAergic and serotonergic pathways. The flavonoids and saponins found in the leaves could be responsible for the observed effect.