Pattern of Serious Adverse Events Associated with Administration of Different Vaccines: A US Vaccine Adverse Event Reporting System (VAERS) Database Analysis

ABSTRACT

Different vaccine adverse event surveillance systems have been developed down the years to act as an early warning system to detect signals regarding adverse events following vaccination. Different types of serious adverse events were characterized through the analysis of US VAERS registry. Methods: The VAERS data from 2010-2019 was analysed statistically for exploration of different types of serious adverse events and the signs and symptoms associated with administration of these vaccines. Vaccines implicated in serious adverse events through VAERS were further explored for correlates in WHO Vigibase database. Results: The maximum number of patients with serious events were administered FLU3 vaccine (n=4024, 12.71%), followed by PNC13 (n=2740, 8.66%), VARZOS (n=2310, 7.30%), PPV (n=1964, 6.20%) and HIBV vaccine (n=1448, 4.57%). Of all symptoms in patients with serious adverse events, pyrexia was the major symptom in patients with life threatening illness (16.06%), hospitalization (18.83%), prolongation of hospitalization (19.64%), disability (12.05%) and mortality outcome (9.95%). Among the top three vaccines implicated in serious adverse events, analysis through WHO Vigiaccess database found general disorders and administration site conditions and skin and subcutaneous tissue disorders to be the MedDRA major system organ classes for both pnemococccal and varicella zoster vaccine. Conclusion: FLU3 (Influenza), PNC13 (pneumococcal) and VARZOS (varicella zoster) vaccines were the top three vaccines implicated in serious adverse events through VAERS database analysis though a cause and effect relationship cannot be established through the this data alone.