European Union reporting system shows millions of adverse reactions to COVID-19 vaccines

by mcardinal

Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News 


A new report from the European Union collection system reveals that there have been over 30,000 fatalities and 1.1 million adverse reactions linked to the four COVID-19 vaccines that are available in the EU.

EudraVigilance, the European database of suspected adverse drug reaction reports is a system similar to VARES that collects adverse events and side effects from medications. Healthcare professionals and pharmaceutical companies are legally required to electronically submit adverse reactions, and in 2012 the European Medicines Agency created a website to give the public access to these reports. 

The majority of the vaccine injury reports have been classified as severe and many side effects were more likely to occur after individuals received a second dose of their COVID-19 vaccine. 

The EudraVigilance database reports that through November 13, 2021 there were 30,355 total fatalities linked to the Pfizer BioNTech, Moderna, AstraZeneca, and Janssen Pharmaceuticals/ Johnson & Johnson COVID-19 vaccines and 1,163,356 injuries that were reported following injections. 

The most common adverse reactions were general disorders and discomfort at the administration site, such as redness, swelling, and soreness. Other common adverse events were nervous system disorders, blood and lymphatic system disorders, cardiac disorders, musculoskeletal and connective tissue disorders, and respiratory, thoracic, and mediastinal disorders. Fatalities occurred at the highest rates in cardiac, respiratory, and nervous system disorders as well as infections.  

In the U.S., it is estimated that only 1% of vaccine adverse events are reported, as many healthcare providers are unaware that this system even exists and are only encouraged to report suspected adverse reactions. The European Medicines Agency publishes monthly safety updates for the COVID-19 vaccines authorized in the EU and the data is summarized into different categories based on individual cases and types of reactions.

All reports of suspected side effects that are reported to EudraVigilance include serious and non-serious side effects. Serious side effects are events that result in death, are life-threatening, require hospitalization, results in either a disability, a congenital anomaly, or birth defect, or results in any other medically important condition. 

Many healthcare professionals and experts refuse to acknowledge that while correlation does not always equal causation, the increased number of reports of adverse events and death should indicate a need for an investigation. However, the European Commission has forged ahead, purchasing 4.6 billion doses of COVID-19 vaccines while also negotiating deals for additional doses. To date the EU has administered over 900 million doses of COVID-19 vaccines from Pfizer-BioNTech, Moderna, AstraZeneca, and Janssen Pharmaceuticals/Johnson & Johnson as well as a number of other vaccines that are under review or are in various stages of development. 

Many believe that these reporting systems are unreliable and inaccurate and cannot accurately prove if a reaction or death was caused by vaccination or was coincidental due to some underlying disease process. However, most side effects occur immediately or within the first few weeks after vaccination, and are more likely to appear after the second dose.

With the increased incidences of cardiac events, blood clots, and nervous system disorders, as well as death, especially in persons aged 18-64, further investigation should be considered.