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Evaluation of Vaccines Adverse Events Reporting System (VAERS) Related to Childhood Vaccines in Kingdom of Saudi Arabia, 2017-2020.


Vaccination-associated adverse events are common among children and need to be monitored for evaluating the safety profile of immunization programs. Ministry of Health (MOH) of the Kingdom of Saudi Arabia (KSA) has launched the Vaccines Adverse Events Reporting System (VAERS) for same purpose. This study aims to evaluate adverse events related to childhood vaccines from VAERS data.


A record-based descriptive study was carried out for all the reported vaccine adverse events (AE) in MOH-VAERS during 2017-2020 among children under six years of age in KSA. Data were extracted from the electronic reporting system for medical history, age, region, date of immunization, reaction onset, type, duration, site, and impact on hospitalization.


Our analysis showed fever as the most common AE in one-year-olds following a combination vaccine against measles, mumps, rubella (MMR). Overall, the three-year trend showed AE exhibiting gender-specific variation, with a slight male preponderance. These events were also more common in Saudis of the eastern region that are better equipped with health care facilities, showing a clear region-specific pattern.


Childhood vaccine-related AE are usually mild and treatable and are bearable compared to risks associated with infection. Our study demonstrated pyrexia following MMR as the most common AE in Saudi male children of the eastern region. The occurrence and patterns of these events are in concordance with international data. Analysis of this data combined with previously published reports on vaccine-related adverse events can help the medical staff's appropriate training.