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COVID-19

COVID-19 Vaccine Safety: New Research Reveals Adverse Reaction Trends

Strategic Insights

— 1 min read

A new study analyzing data from the EudraVigilance database has shed light on the safety profile of COVID-19 vaccines. Conducted by researchers from the Medical University of Gdansk, the retrospective observational study examined 250,966 suspected serious adverse reactions (SADRs) following the administration of 733,837,251 vaccine doses against SARS-CoV-2. The investigation sought to identify symptoms and reporting trends of SADRs related to anti-SARS-CoV-2 vaccines.

Key Takeaways:

  • The study analyzed data from 733,837,251 vaccine doses against SARS-CoV-2, with 62.8% of reported SADRs occurring in females.
  • The most common clinical manifestations of SADRs to anti-SARS-CoV-2 vaccines included neuropsychiatric (121,877 cases), cardiovascular (78,167 cases), and musculoskeletal and connective tissue disorders (63,994 cases).
  • Vaccination with Comirnaty (Pfizer BioNTech) was associated with the lowest risk of experiencing SADRs, with a rate of 754/million administered doses.
  • The risk of SADR associated with vaccination with Spikevax (Moderna) was 785/million doses, Jcovden (Janssen) was 1,248/million doses, and Vaxzevria (AstraZeneca) was 2,301/million doses.
  • The study concluded that the risk of SADR to any SARS-CoV-2 vaccine appears to be outweighed by the benefits of active immunization against the virus.

Statistics:

  • 250,966 suspected SADRs were reported following the administration of 733,837,251 vaccine doses against SARS-CoV-2.
  • The most common types of neuropsychiatric SADRs were identified as anxiety-related disorders (21.6%), sleep disorders (12.3%), and depressive disorders (8.4%).
  • Cardiovascular SADRs accounted for 24.4% of all reported cases, with the majority related to arrhythmias (14.5%) and hypertension (8.1%).
  • Musculoskeletal and connective tissue disorders accounted for 15.6% of all reported SADRs.

Sources:

  • Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database. Scientific Reports, 2025;15(1):18582.
  • NewsRx. Medical University of Gdansk Reports Findings in COVID-19 (Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database). Information Technology Newsweekly. June 10, 2025; p 7.

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