In fact, similar to other medications, vaccines can sometimes cause hypersensitivity reactions, which are typically rare and mostly mild (89, 90). Given the timing of the vaccination campaign, many of these individuals may have been asymptomatic or untested at the time of vaccination, leading to a temporal association between the vaccine and subsequent COVID-19 symptoms. Systemic reactions like headache, fatigue, and fever were among the most frequently reported AEFI for both vaccines, with a higher propensity for serious outcomes in Pfizer reports. Our findings show that for all analyzed vaccines, most cases were reported between 2021 and 2022, primarily concerning women.

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Furthermore, it is crucial to note that VAERS does not validate the causation between COVID-19 vaccines and the AEFIs reported . However, as more data were collected and larger populations were vaccinated, it became evident that the overall rates of AEFIs between the 2 vaccines were comparable. This disparity in the AEFIs reported between Moderna and Pfizer-BioNTech, despite both vaccines using the messenger RNA (mRNA) platform, can be attributed to multiple factors . Notably, the top 5 symptoms reported for all 3 vaccines are headache, fatigue, pyrexia, pain, and chills, with only slight differences in the order of rankings.

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Adults aged years reported these same symptoms, while the elderly also reported SARS-CoV-2 test positivity. The most common symptoms and AEFIs for the Novavax vaccine were dizziness, followed by headache, fatigue, incorrect product formulation, and pain. Furthermore, Multimedia Appendix 2 also provides the same information for each specific year (2020, 2021, and 2022). Regarding vaccine manufacturers, Pfizer-BioNTech had the highest number of VAERS reports, with 20,623 (48.68%) cases, followed by Moderna with 16,936 (39.98%) cases. Of these serious reports, 21,153 (49.93%) were reported by female patients and 20,275 (47.86%) by male patients. Figure S1 in Multimedia Appendix 1 presents a comprehensive breakdown of serious reports analyzed in this study.

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The occurrence of headache can be attributed to the body’s immune response to the vaccine, which triggers the generation of humoral and cellular immunity through a diverse range of mechanisms . Notably, regions II and III demonstrated the highest level of similarity, with an exceptional value of 0.9998, suggesting a strong correlation in the symptoms reported between these regions. The analysis revealed that the similarity between all regions exceeded 0.99, indicating a remarkable degree of similarity in the symptoms reported.

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10 Estimated number of cases based on seroprevalence data in the population and on the risk that women infected during a childbearing year would have a fetus with congenital rubella syndrome. 9 Average annual number of reported cases during 1966–1968, 3 years before vaccine licensure. 7 Average annual number of reported cases during 1958–1962, 5 years before vaccine licensure. 6 Average annual number of reported cases during 1951–1954, 4 years before vaccine licensure. 4 Average annual number of reported cases during 1922–1925, 4 years before vaccine development. 3 Average annual number of reported cases during 1920–1922, 3 years before vaccine development.

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• The VSD links computerized vaccination and medical records for approximately 15.5 million persons (4.7% of the US population), enabling less frequent AEs to be evaluated.
• 1 Disease data presented in the 2020 tables reflect the impacts of the COVID-19 pandemic, such as changes in exposure-related behavior, healthcare-seeking behavior, disease reporting, and public health investigations.

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• Additionally, similarities in health care infrastructure, medical practices, and access to testing facilities may contribute to the observed similarities in the symptoms reported.
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Although some of these disorders are documented in the literature, there remains a significant gap in understanding how various AEFI co-occur within these clinical entities, as not all affected women experience just a single symptom. Additionally, other emerging safety concerns have been noted in specific groups, such as menstrual disorders in women of reproductive age, including menorrhagia, metrorrhagia, and polymenorrhea (33, 34). Neurological disorders present another area of underexplored safety signals, encompassing a wide range of signs and symptoms from headaches to transverse myelitis, many of which are poorly characterized in existing studies (28–32). In particular, the pediatric population requires specific attention in pharmacovigilance efforts, as adverse events such as myocarditis, although rare, have been reported, especially among adolescent males (21, 22). The rapid spread of COVID-19 has necessitated the accelerated development and deployment of innovative vaccine technologies (7).

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Below are some examples of how VAERS data have contributed to public health, listed by some of the major objectives of VAERS. All reports are accepted and entered without case-by-case determination of whether the AEs could have been caused by the vaccine in question. Approximately 60,456 US reports of AEs following immunization were received by VAERS in the first six months of 2023 (CDC, unpublished data).