Abstract :
Introduction: Adverse effects following vaccination must be reported and assessed in order to promote the patient safety and well-being.
Objective: The aim of this study was to observe the pattern of adverse drug reactions (ADRs) following ChAdOx1 nCoV-19 (COVISHIELD) Vaccine.
Materials and Methods: Study was conducted at Dr. RPGMC, Kangra at Tanda, which has a dedicated COVID-19 hospital, ADR monitoring Centre, COVID-19 vaccination Centre & a hospital with 700 bedded multi-specialty tertiary healthcare Centre situated in North India. Assessment was carried-out for the pattern of ADRs reported by the volunteers receiving COVID-19; ChAdOx1 nCoV-19 (COVISHIELD) vaccine from January to December 2021. Data such as age, gender, drug intake, types of ADRs, treatment and outcome of the reactions were collected. Each reported patient was assessed individually. Causality assessment was done on WHO scale. ADR profiling on the basis of site, onset, organ system affected, duration, whether urgent referral was required or not and resolution of signs & symptoms.
The data is analyzed and expressed as mean ± standard deviation & percentages.
Results: A total of 21,115 volunteers got vaccinated at our Centre from 16 January 2021 to 31 December 2021. Less than 1% (201) vaccinees reported AEFIs and all those who reported AEFIs had mild symptoms and recovered. Immune system related adverse effects (55.2%) were most common. Fever, drowsiness, headache, vomiting, injection site pain/swelling/tenderness and body aches were the most commonly reported adverse effects.
Conclusion: Reporting of vaccine adverse effects and availability of safety data on public platform is an important factor in increasing the vaccine acceptability by the people and henceforth better health. ChAdOx1 nCoV-19 COVISHIELD vaccine is proved to be a safe vaccine against COVID-19 in adults.
Keyword :
AEFI, ChAdOx1, COVISHIELD, nCoV-19 & COVID-19