RESUMEN
@#Objective To investigate the characteristics of distribution of adverse event(AE)associated with human papillomavirus(HPV)vaccine by analysis of data on AE collected from the Vaccine Adverse Event Reporting System(VAERS).Methods The data on AE reported in VAERS from January 1st,2006 to December 31st,2021 were analyzed and compared by using Pearson Chi-square test and Mann-Whitney U test.Results A total of 53 571 cases of AE were included in the study,in which the ratio of male to female was 0. 25∶1,and the median age of vaccinees was 15 years. A portion of 36. 1%of AE occurred after the first dose,while 90. 7% occurred within 3 d after vaccination. Both the gender ratios(χ~2=72. 570,P < 0. 001) and the median ages(Z = 4. 255,P < 0. 001)of vaccinees in non-serious and serious adverse event(SAE)showed significant difference. In terms of classification of SAE,hospitalization,prolonged hospitalization and disability were more common in females than in males,of which the percentages decreased with the increasing age. Among the AE,syncope was the most common clinical symptom. In the SAE,the highest proportion of deaths was caused by HPV2 vaccine,which was 19. 0%. The proportion of prolonged hospitalization caused by HPV4 vaccine was higher than that by HPV9vaccine. In general,HPV4 vaccine was more prone to cause SAE than HPV9 vaccine(χ~2=183. 267,P < 0. 001).Conclusion In all the AE,the largest proportion occurred in the age group of 9 ～ 17 years,followed by those in the groups of 18 ～ 26 and 27 ～ 45 years. Most of the AE occurred after the first dose. The clinical symptoms of AE caused by three vaccines were different. The analysis of distribution characteristics of AE may provide a reference for the study on clinical safety of HPV vaccine and optimization of vaccination.
RESUMEN
: 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.