Adverse events following immunization of COVID‐19 (Covaxin) vaccine at a tertiary care center of India

Parida, Swayam Pragyan; Sahu, Dinesh Prasad; Singh, Arvind Kumar; Alekhya, G; Subba, Sonu Hangma; Mishra, Abhisek; Padhy, Biswa Mohan; Patro, Binod Kumar

doi:10.1002/jmv.27655

Cited by 43 publications

(56 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…13,24 The adverse reactions reported by study participants (body weakness, fever, headache, and pain at injection site) are consistent with previous findings. 17,19,20,25,26 This pattern and types of adverse reactions have been observed to be more common among recipients of the Astrazeneca vaccine; 14,15.25 similarly, in this study, all the study participants received only the Astrazeneca vaccine. The side effects of most COVID-19 vaccines usually disappear within a few days of receiving the vaccine; 15,23 in this study as well, up to 99% of the side effects experienced disappeared within few a minutes to two days.…”

Section: Discussionsupporting

confidence: 55%

Prevalence and pattern of adverse events following COVID 19 vaccination among adult population in Sokoto metropolis, northwest, Nigeria

Adamu

Lawal

et al. 2022

Preprint

View full text Add to dashboard Cite

Background: COVID-19 still poses a major public health challenge worldwide and vaccination remains one of the major interventions to control the disease. Different types of vaccines approved by the World Health Organization (WHO) are currently in use across the world to protect against the disease. As all vaccines are associated with some adverse reactions (ARs), this study assessed the prevalence and pattern of adverse events following immunization (AEFI) after receiving COVID-19 vaccine among the adult population in Sokoto metropolis, North-west, Nigeria Methods: We conducted a cross-sectional study among 230 adults in Sokoto metropolis who received COVID-19 vaccine. Data was collected using a structured questionnaire administered via personal phone calls to respondents who were selected via a systematic sampling technique. For data analysis, IBM SPSS version 25.0 was used. Results: The Majority of the participants [183 (79.7%)] experienced AEFI. The most common adverse events were body weakness [157(85%)], fever [111(60.3%)] and headache [103(56%)]. Up to half of the respondents that experienced AEFI said it occurred within minutes and a few hours, whereas 75 (40.8%) said it was within 2-3 days. Up to 66.3 of the adverse reactions were mild and lasted between a few hours (37.5%) and one day (31.5%); however, 15.2% of the respondents had severe reactions of which 22.7% were admitted to a health facility. The development of AEFI was linked to the absence of an underlying medical condition, a previous history of AEFI, and a history of drug reaction. Conclusion: The majority of respondents reported adverse events following COVID-19 vaccination, with body weakness, fever, and headache being the most common AEFIs. The underlying medical condition as well as a history of adverse drug reactions were predictors of the development of adverse reactions following COVID-19 vaccination. Service providers at each COVID-19 vaccination point should always take the time to explain to vaccine recipients that adverse reactions are possible; however, they should reassure them that most ARs resolve within a few hours to a few days.

show abstract

Section: Discussionsupporting

confidence: 55%

Prevalence and pattern of adverse events following COVID 19 vaccination among adult population in Sokoto metropolis, northwest, Nigeria

Adamu

Lawal

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…These two co-variates have recently been projected as risk factors of AEFI after COVAXIN in adults by a group from eastern India. 15 Female sex, history of allergy and presence of hypothyroidism have been proposed as determinants of AEFI after COVISHIELD in adults. 11 The association of AEFIs with hypothyroidism could not be examined in the present study because of a small number of individuals with thyroid disorders.…”

Section: Discussionmentioning

confidence: 99%

A prospective observational study on BBV152 coronavirus vaccine use in adolescents and comparison with adults- first real-world safety analysis

Kaur

Chauhan

et al. 2022

Preprint

View full text Add to dashboard Cite

Background: The BBV152 COVID-19 vaccine (COVAXIN) has recently been approved for adolescents. We provide the first real world safety data of COVAXIN use in adolescents and compare this with adults. Methods: A prospective observational study is being conducted since January 2022. Enrolled adolescents and adults were contacted telephonically after 14 days of receiving the BBV152 vaccine. Primary outcome was vaccine safety assessed as rates of adverse events following immunization (AEFI). Severity grading of AEFIs was done using the FDA scale. Findings: A total of 698 adolescents and 326 adults were enrolled. AEFIs occurred in 36.3% adolescents after first and in 37.9% after second dose. Systemic involvement was seen in 15-17% adolescents. Injection site pain and fever were the common AEFIs. Majority of AEFIs were mild-moderate. Severe and atypical AEFIs were observed in 0.9% and 0.6% adolescents respectively. Majority of AEFIs recovered in 1-2 days. In >2% adolescents, AEFIs were persisting at 14-day follow-up since the second dose. No difference in AEFI incidence and patterns was observed between adolescents and adults. Regression analysis showed females and those with history of allergy to be respectively at 1.5-times and 3-times increased risk of AEFIs among adolescents. Interpretation: COVAXIN carries an overall favorable short term safety profile in adolescents. The observed AEFI rates in adolescents are much lower than that reported with mRNA vaccines. Female adolescents and those with history of allergy need watchfulness. With some AEFIs persisting at 14 days, a longer follow-up is recommended to strengthen the safety data of these vaccines. Funding: No funding support

show abstract

“…A higher reactogenicity after the second dose has previously been demonstrated for mRNA-based COVID-19 vaccines [ 14 ]. The viral vectored vaccines and inactivated vaccines, on the other hand, have displayed lesser reactogenicity with the second dose [ 7 , 8 , 15 , 16 ]. The observation of increased reactogenicity with the second dose in the present study, however, needs a cautious interpretation.…”

Section: Discussionmentioning

confidence: 99%

“…Regression analysis showed female adolescents and those with a history of allergy to be at 1.6 times and 3 times higher risk of developing AEFIs, commonly from the SOC of general disorders. These two co-variates have recently been projected as risk factors of AEFI after COVAXIN in adults by a group from eastern India [ 16 ]. Female sex, a history of allergy, and presence of hypothyroidism have been proposed as determinants of AEFI after COVISHIELD in adults [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis

et al. 2022

View full text Add to dashboard Cite

Introduction The BBV152 coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) has recently been approved for adolescents. Objective We provide the first real-world safety data of COVAXIN use in adolescents and compare with adults. Methods A prospective observational study was initiated in January 2022. Enrolled adolescents and adults were contacted by telephone after 14 days of receiving the BBV152 vaccine. The primary outcome was vaccine safety assessed as rate of adverse events following immunization (AEFIs). Severity grading of AEFIs was done using the Food and Drug Administration (FDA) scale. Interim results are presented. Results A total of 698 adolescents and 326 adults were enrolled. AEFIs after the first dose developed in 243 out of 670 adolescents (36.3%), with 21% reporting only local AEFIs and 15.2% reporting systemic AEFIs. Among 340 adolescents who had received the second dose of vaccine, 129 (37.9%) developed AEFIs, with only local involvement in 20.3% and systemic involvement in 17.6%. Injection site pain and fever were the common AEFIs. The majority of AEFIs were mild-moderate. Nearly 0.9% of adolescents receiving the first dose reported severe AEFIs. Atypical AEFIs were observed in 0.6–0.9% of adolescents. The majority of the AEFIs resolved in 1–2 days. AEFIs were persistent in > 2% of adolescents at day 14 after the second dose, and also in 3.7% of adults overall at follow-up. No difference was observed in AEFI incidence and patterns between adolescents and adults. Regression analysis showed females and those with a history of allergy to be, respectively, at 1.6 times and 3 times increased risk of AEFIs among adolescents. Conclusions COVAXIN carries an overall favorable short-term safety profile in adolescents. The observed AEFI rates in adolescents are much lower than that reported with mRNA vaccines, but head–head comparisons in the same population are required to generate relative vaccine safety data. Female adolescents and those with a history of allergy need watchfulness for severe and persistent AEFIs. With some AEFIs persisting at 14 days, a longer follow-up is recommended to strengthen the safety data of COVAXIN.

show abstract

Adverse events following immunization of COVID‐19 (Covaxin) vaccine at a tertiary care center of India

Cited by 43 publications

References 15 publications

Prevalence and pattern of adverse events following COVID 19 vaccination among adult population in Sokoto metropolis, northwest, Nigeria

Prevalence and pattern of adverse events following COVID 19 vaccination among adult population in Sokoto metropolis, northwest, Nigeria

A prospective observational study on BBV152 coronavirus vaccine use in adolescents and comparison with adults- first real-world safety analysis

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis

Contact Info

Product

Resources

About