Vaccines: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Side effects people report

11,473 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Covid-191,343 reports
  2. 2Fatigue1,175 reports
  3. 3Pyrexia1,099 reports
  4. 4Headache1,019 reports
  5. 5Pain1,015 reports
  6. 6Dyspnoea954 reports
  7. 7Arthralgia888 reports
  8. 8Diarrhoea791 reports
  9. 9Nausea715 reports
  10. 10Malaise679 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on vaccines

Countries side by side on public measures for this topic.

All benchmarks

Acuitas market sizes and forecasts are only in our full reports. How we use public data.