Study design

The study was designed as a two-stage, cross-section survey of randomly sampled Covishield-vaccinated individuals in eastern Nepal who were vaccinated for the first dose between 27 January and 5 March 2020.

Setting

The study was conducted in the Dhankuta district and its periphery, specifically in a secondary hospital, two primary health centres and 36 health posts. As of 7 July 2021, only 2.7% of Nepal’s population has been fully vaccinated, largely owing to poor user confidence and limited access to vaccines.

Participants

Our study population encompassed healthcare workers and support staff, female community health volunteers, government workers, people’s representatives, media workers, security personnel, sanitation workers, older adults living in care homes, and prisoners who received their first dose of Covishield during the first phase of Nepal’s national COVID-19 vaccination campaign. The complete list of vaccinated individuals in Dhankuta and its periphery available from Dhankuta District Health Office was used as the sampling frame, from which participants were randomly selected via lottery. The sample size was calculated with a pre-set formula [19], (Z = 2.57, p = 0.5, d = 0.05) with margins of 10% for both non-response in the first round and attrition in the second. Of 637 individuals approached, 602 completed the first round (non-response rate = 5.6%), while 516 of 602 completed the second (attrition rate = 14.3%).

Patient and public involvement

There was no patient or public involvement in this research.

Study tools

Data was collected using a semi-structured self-prepared questionnaire administered in two rounds following two vaccine doses from March 15 to April 15, 2021. The questionnaire was based on multiple previous studies [20,21,22], and was thoroughly pre-tested in a representative population of the study area. It was revised following the feedback from interviewing doctors and reviewed by the ethical review board. The questionnaire consisted of three broad sections respectively addressing participants’ socio-demographic and professional characteristics (i.e. age, gender, marital status, occupation profile, and level of education), prior disease burden and risky behaviours (i.e. existing long-term comorbidities, current medication, tobacco use, and alcohol consumption), and COVID-19 exposure and vaccination (i.e. prior COVID-19 infection of self and family, involvement in COVID-19 treatment, source of information about vaccination, initial opinions about vaccination, confidence in the vaccines, willingness to be vaccinated, vaccination coercion, vaccination date, post-vaccination symptoms, time of onset and duration of any symptoms, medications, and likelihood of receiving the second dose). After a minimum of 21 days from each dose of Covishield, we interviewed participants face-to-face with their oral and written consent. Telephone interviews were performed in the second round whenever physical access was impossible.

Study variables

Outcome variables were the incidence, onset, duration, and severity of AEs (i.e. pain in injected arm, swelling in injected arm, fever, headache, shivering, muscle pain, joint pain, throat pain, bodily weakness, coughing, shortness of breath, common cold, sleep disturbance, loose stool, and loss of smell). Internal consistency of adverse event variables was found to be excellent (Cronbach’s (alpha =0.9)). We obtained maximum temperature recorded for fever, frequency for loose stool, and presence or absence for loss of smell. By severity, the AEs were classified into three categories: mild (i.e. without impact on working ability), moderate (i.e. with impact on working ability without consultation or hospitalization), and severe (i.e. resulting in medical consultation or hospitalization). We also collected information on comorbidities, if any, and drugs currently being taken. Vaccine recommendation is willingness to recommend vaccination to others by the vaccinated individual following the first dose. As interview happened, at minimal, after 21 days, vaccine recommendation catches potential opinion change on vaccination due to the AEFI.

Bias

Although vaccination was offered to the high-risk group, the decision to be vaccinated was left to individuals. That dynamic engendered self-selection, whereby people who favoured vaccination decided to be vaccinated and thus are sampled in our survey.

Statistical analysis

Herein, we report the frequency, percentage, and confidence interval (95% CI) for sociodemographic characteristics, comorbidities, drug use, perceptions of COVID-19, and adverse events following immunisation (AEFIs), as well as the incidence, onset, duration, severity, and medication used. Quantitative data obtained from the field were coded and parsed using MS Excel and analysed in R 4.0.1. [23]. The chi-square test was used to determine associations when appropriate.

Ethical considerations

Ethical approval was obtained from the Nepal Health Research Council (Ethical Review Board Protocol Registration No. 325/2021 P) after the submission of a brief research proposal, which was subjected to double-blind review and certified to fulfil the required protocol. All methods were performed in accordance with the relevant guidelines and regulations of NHRC. Informed consent was obtained from all the participants.

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