Post-Vaccination Adverse-Effect Profile Among Adult Beneficiaries of a Tertiary-Care Hospital in Rajasthan: A Prospective

Abstract

Background: Robust pharmacovigilance is essential to sustain public confidence in India’s COVID-19 immunisation drive. Published data from northern India remain limited, and heterogeneity persists in reporting practices.

Methods: We undertook a six-month, single-centre, prospective, comparative cohort study at Mahatma Gandhi Medical College & Hospital, Jaipur (IEC No. MGMC&H/IEC/JPR/2021/508; 21 June 2021). All consecutive adults (≥18 y) receiving either dose of Covishield™ or Covaxin™ between July-December 2021 were observed on-site for 30 min and contacted telephonically on day 1, 3 and 7. Adverse events following immunisation (AEFI) were graded (mild/moderate/severe) using Government of India guidelines. Primary outcome was cumulative incidence of any AEFI after dose 1 versus dose 2. Predictors were explored using multivariable logistic regression.

Results: Of 613 recipients (mean age 36.4 ± 12.1 y; 53.2 % male), 54.5 % reported ≥1 AEFI after dose 1 versus 35.5 % after dose 2 (p < 0.001). Local pain (41 %), fever (23 %), myalgia (13 %), fatigue (12 %) and headache (8 %) predominated. Almost 83 % of AEFI were mild and self-limiting; no anaphylaxis or thromboembolic events were recorded. Independent predictors of systemic AEFI were female sex (aOR 1.43, 95 % CI 1.02-2.00), age <30 y (aOR 1.57, 1.08-2.28) and previous SARS-CoV-2 infection (aOR 1.68, 1.05-2.70).

Conclusion: Both vaccines exhibited favourable short-term safety profiles; reactogenicity declined significantly after the second dose. Active surveillance should be continued to capture rarer, late-onset events and to strengthen public trust.