Adverse event reporting systems, such as the Yellow Card scheme in the U.K. or VAERS in the U.S., are designed to help health authorities monitor the safety of medical products such as the COVID-19 vaccines. However, the databases contain unverified information and cannot demonstrate that COVID-19 vaccines caused adverse events. The reports can be a starting point for a detailed investigation into potential side effects, which happened for rare cases of blood clotting and anaphylaxis. Overall, the U.K. regulatory body, the MHRA, still concludes that the benefits of the COVID-19 vaccines outweigh their known risks.
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Both COVID-19 vaccines approved for emergency use by the U.S. Food and Drug Administration were thoroughly reviewed for safety and efficacy before approval. The U.S. Adverse Events Reporting System (VAERS) enables the public and healthcare providers to report adverse events that occur after vaccination. It serves as an early warning system for potential problems with vaccines. However, determining whether there is a causal link requires further investigation into these reports. VAERS data only tells us that an adverse event occurred after vaccination; on its own it cannot prove that vaccines caused the adverse event.
The COVID-19 vaccines were initially issued in the U.S. under Emergency Use Authorization by the FDA, which requires every serious adverse event that occurred post-COVID-19 vaccination to be reported, regardless of whether healthcare providers believe the vaccine was the cause. This led to an increase in the number of deaths reported in VAERS following the rollout of the COVID-19 vaccines in 2021. However, studies have shown that vaccinated people don’t experience a higher risk of mortality compared to unvaccinated people.
Studies have found that pregnant women who get COVID-19 are more likely to develop complications and carry a higher risk of death. Multiple scientific studies have shown that serious side effects following COVID-19 vaccination are rare and the benefits of vaccination outweigh the risks. There’s currently no evidence that getting a COVID-19 vaccine together with another vaccine, like the flu vaccine, leads to serious adverse outcomes.
Health authorities use various complementary vaccine safety monitoring systems to ensure vaccines are safe. In May 2023, the CDC paused its app-based monitoring system v-safe. However, other systems, including VAERS, are still operational. Health authorities are still collecting data on vaccine safety.
The VAERS database is a pharmacosurveillance tool used to detect early signs of unusual adverse event patterns following vaccination. However, on its own, it cannot prove that a vaccine caused the reported adverse events, including deaths. Therefore, VAERS data alone don’t show that COVID-19 vaccines are dangerous.
Studies show that COVID-19 vaccines don’t increase the risk of death. On the contrary, they reduce it by protecting people against severe illness and death, particularly among populations at a higher risk of severe COVID-19. While COVID-19 vaccines are associated with some serious side effects, this risk is very small and doesn’t outweigh the benefits of vaccination.
Even before COVID-19 vaccines existed, there was already a baseline rate of illness and death occurring in the general population. The occurrence of an adverse event after vaccination in itself doesn’t necessarily mean the vaccine caused the event. To determine whether vaccination alters the risk of such events, researchers need to compare the baseline rate and the rate in vaccinated people. Multiple scientific studies have shown that serious side effects following COVID-19 vaccination are rare and the benefits of vaccination outweigh the risks.
Incidental illnesses, including neurological conditions, occur regardless of vaccination. Individual case reports and data from vaccine surveillance systems are generally insufficient on their own to establish a causal link between these events and the vaccine, so further investigations are needed to determine whether a vaccine caused these events. Epidemiological studies show that neurological adverse events after COVID-19 vaccination are very rare, much rarer than after SARS-CoV-2 infection, suggesting that the benefits of COVID-19 vaccines outweigh this potential risk.
COVID-19 vaccination provides the best protection against COVID-19. Like any other vaccine, COVID-19 vaccines can cause side effects, but most of them are mild and disappear after a few days. While serious reactions to vaccination can occur, they are very rare. Current evidence indicates that the potential risks of vaccination don’t outweigh their benefits at preventing severe COVID-19 and death.