• A prospective observational study interviewed 1024 individuals telephonically regarding long-term adverse events of special interest (AESIs) following a year of vaccination among adolescents and adults who received the BBV152 vaccine (Covaxin). 

• The study determined the risk factors for AESIs and AESIs that lasted for a minimum of one month.

• The most common AESIs among adolescents were as follows:

1. Viral upper respiratory tract infections (47.9%)

2. New-onset skin and subcutaneous disorders (10.5%)

3. Nervous system disorders  (4.7%) 

• Similarly, the most common AESIs among the adults were as follows:

1. Viral upper respiratory tract infections (42.6%)

2. Musculoskeletal disorders (5.8%) 

3. Nervous system disorders (5.5%)  

• A few other AESIs were also noted, such as Guillain–Barre syndrome, menstrual abnormalities, and ocular abnormalities.

• The development patterns of AESIs following BBV152 were not the same as those observed with other COVID-19 vaccines against COVID-19, nor were they consistent between adolescents and adults.

• Further comparative studies would be required to understand the association of Covaxin with the AESIs.

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