Active Symptom-Based Surveillance of Adverse Events Following Immunization Among Individuals Vaccinated with ChAdOx1 nCoV-19 Coronavirus Vaccine in a Tertiary Hospital of Kerala

Abstract

Background: The reports on adverse experiences following vaccination are scanty from India. It is important to know the real-world post-vaccination experience outside of clinical trial conditions Objectives: To estimate the incidence of adverse events following immunization with ChAdOx1 nCoV-19 coronavirus vaccine and to identify the predictors for development of vaccine adverse events Materials and Methods: A prospective observational study was conducted among health care workers who received the ChAdOx1 nCoV-19 coronavirus vaccine. Study participants were monitored at the site for 30 min following vaccination and were followed up for 7 days after receiving the second dose, with a purpose-specific designed online surveillance form to enquire about any adverse events following vaccination. We used the Chi-squared test for categorical variables and multivariate regression analysis to identify predictors for the development of vaccine adverse effects. Results: Of 411 participants, the mean age was 30.77 ± 12.5 years and 76.2% were females. Overall, 207 (50.4%) respondents reported at least one post-vaccination symptom receiving either dose of coronavirus vaccination. Fever (34.8%), local pain at the injection site (28.0%), tiredness (25.5%), chills (20%), myalgia (18.7%), headache (17.8%), injection site stiffness (5.4%), joint pain (4.6%) and nausea-vomiting (3.8%) were the most prevalent symptoms following the first dose. Adverse reactions reported after the second dose were milder and less frequent. Post-vaccination symptoms were more likely in the younger age group, those with comorbidity particularly, bronchial asthma and who had a history of allergy to food/drugs. Conclusion: All the adverse reactions were of a minor type and non-serious. Side effects were less common in older adults (>60 years). Reactions to the second dose were lesser in intensity and frequency. Younger age, history of allergy, and comorbidities, particularly asthma were found to be major predictors for the development of adverse events and require more watchful vaccine administration

Assessment of safety and adverse events following COVID-19 vaccination and their predictors in first 30 days among healthcare workers of a tertiary care teaching hospital in North India

“…Among those participants experiencing any AEFI in our study, majority (119, 99.0 %) experienced only mild/minor grade AEFI with only 2(1.0 %) experiencing a severe AEFI requiring hospitalization but without any sequelae or long-term complication. Similar results were reports by other studies from various parts of India [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] and across the globe [29] , [30] , [31] , [32] , [33] . In the study by Kamal et al [22] , two serious AEFI (altered sensorium) were reported within 48 h after the 1st dose of COVISHIELD TM vaccine.…”

“…Studies by Kushwaha et al [17] from North India and Kujur et al [18] from Eastern India assessing AEFI with 1st dose of COVISHIELD and Parida et al [16] from Eastern India assessing AEFI with Covaxin reported similar figures of 30.4 %, 33.6 % and 29.8 % respectively. However, studies by Kaur U et al [19] , Kaur S et al [20] and Jha et al [21] from North India reported the incidence of AEFI as 40.0 %, 46.0 % and 73.9 % respectively with 1st dose of COVISHIELD TM whereas studies by Kamal et al [22] , Jose M et al [23] , Jose D et al [24] and Manda et al [25] from Southern India and study by Velhal et al [26] from Western India reported the incidence of AEFI as 57 %, 50.4 %, 54.3 %, 49.9 % and 94.4 % respectively, much higher than our finding. However, Joshi et al [27] from Northern India and Basavaraja et al [28] from Southern India reported the incidence of AEFI as 6.4 % and 4.3 % respectively after 1st dose of COVISHIELD, much lower than our figure.…”

A systematic review and meta-analysis of the effectiveness and safety of COVID-19 vaccination in older adults

“…Finally, the same indicators (including author, year of publication, number of participants, and vaccination efficacy and safety) could be extracted from eight qualitative analysis articles (62)(63)(64)(65)(66)(67)(68)(69), which are shown in Appendix 6. However, these studies could not be included in the meta-analysis due to insufficient data and/or descriptive explanations of vaccination efficacy and safety without the use of a parallel control, among other reasons.…”

“…However, these studies could not be included in the meta-analysis due to insufficient data and/or descriptive explanations of vaccination efficacy and safety without the use of a parallel control, among other reasons. One article reported the VE (63), three articles reported antibody titer levels after vaccination (64,65,69), and six articles reported the occurrence of vaccine-related adverse events in the elderly (62,(64)(65)(66)(67)(68).…”

Adverse events following immunization of ChAdOx1 nCoV-19 vaccine among healthcare workers of a medicine-teaching institution of North India

“…The most common symptoms found in a study in the tertiary hospital of Kerala were fever, local pain at the injection site, tiredness, chills, myalgia, headache, injection site stiffness, joint pain, and nausea/vomiting after the first dose. [ 23 ] National AEFI Committee of India, on June 4, 2021, reported the first death due to anaphylaxis to vaccine product of Covishield. [ 24 ] In phase II HCT of COVAXIN (6 μg with aluminum gels (Algel)-imidazoquinoline derivative (IMDG)), AEFI (expressed in percentage of total participants in 6 μg with Algel-IMDG group) for the first and second dose, respectively, were pain at the injection site, redness at the injection site, itching, stiffness in the upper arm, weakness in injection arm, body ache, fever, headache, malaise, weakness, rashes.…”