Background incidence rates of selected adverse events of special interest (AESI) to monitor the safety of COVID-19 vaccines

Incidence and Nature of Adverse Events Following COVID-19 Second Boosters: Insights from Taiwan's Universal Vaccination Strategy

“…Additionally, the reliance on self-reported data may lead to an inflated incidence rate due to the underreporting of non-events. There is notable variability in AE incidence rates across large pharmacovigilance databases, as seen in recent studies [8][9][10][11][12]. Our findings contribute further insights into common but non-fatal AEs, consistent with the general profile of vaccine-related side events that are typically transient and resolve without serious consequences [2,[8][9][10][11]34,35].…”

“…There is notable variability in AE incidence rates across large pharmacovigilance databases, as seen in recent studies [8][9][10][11][12]. Our findings contribute further insights into common but non-fatal AEs, consistent with the general profile of vaccine-related side events that are typically transient and resolve without serious consequences [2,[8][9][10][11]34,35]. Therefore, the high incidence rate observed should be interpreted within the larger framework of vaccine safety, emphasizing that the benefits of protection against COVID-19 far outweigh the minor discomforts associated with these non-serious AEs, a fact that should be clearly communicated to address public concerns.…”

“…While vaccines remain one of the most effective means to prevent diseases, vaccine-related adverse events have always been a concern for the public [5][6][7]. Recent studies from large pharmacovigilance databases indicate substantial variability in adverse event incidence rates, emphasizing the need for context-specific analysis in vaccine safety surveillance to maintain public trust and inform future vaccination strategies [8][9][10][11][12]. There are numerous reports of Disclaimer/Publisher's Note: The statements, opinions, and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s).…”

Incidence and Nature of Short-Term Adverse Events following COVID-19 Second Boosters: Insights from Taiwan’s Universal Vaccination Strategy

“…Additionally, the reliance on self-reported data may lead to an inflated incidence rate due to the underreporting of non-events. There is notable variability in AE incidence rates across large pharmacovigilance databases, as seen in recent studies [ 8 , 9 , 10 , 11 , 12 ]. Our findings contribute further insights into common but non-fatal AEs, consistent with the general profile of vaccine-related side effects that are typically transient and resolve without serious consequences [ 2 , 8 , 9 , 10 , 11 , 35 , 36 ].…”

“…While vaccines remain one of the most effective means to prevent diseases, vaccine-related adverse events have always been a concern for the public [ 5 , 6 , 7 ]. Recent studies from large pharmacovigilance databases indicate substantial variability in adverse event incidence rates, emphasizing the need for context-specific analysis in vaccine safety surveillance to maintain public trust and inform future vaccination strategies [ 8 , 9 , 10 , 11 , 12 ]. There are numerous reports of adverse events following COVID-19 vaccination, with particular emphasis on specific groups such as the elderly [ 13 ], pregnant women [ 2 , 14 , 15 ], and those with pre-existing medical conditions.…”