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Appendicitis as a possible safety signal for the COVID-19 vaccines

Joseph Mitchell1, Qun-Ying Yue1

  • 1Uppsala Monitoring Centre, Bredgränd 7, Uppsala 753 20, Sweden.

Vaccine: X
|November 8, 2021
PubMed

Insights

This review of COVID-19 vaccine safety reports found a potential link between vaccination and appendicitis. Further global studies are needed to confirm any causal relationship.

Area of Science:

  • Vaccinology
  • Gastroenterology
  • Pharmacovigilance

Background:

  • Appendicitis has been flagged as a potential adverse event following COVID-19 vaccination.
  • A numerical increase in appendicitis cases was observed in the vaccine arm of a clinical trial.

Purpose of the Study:

  • To investigate reported cases of appendicitis following COVID-19 vaccination.
  • To analyze the characteristics and potential associations of these cases.

Main Methods:

  • Review of individual case safety reports (ICSRs) submitted to VigiBase (WHO database).
  • Inclusion of 334 unique ICSRs from 19 countries after clinical review and exclusion of 24 cases.
  • Analysis of reporting patterns, including time to onset, imaging, and surgical intervention.

Main Results:

  • Disproportionate reporting of appendicitis cases post-COVID-19 vaccination was noted.
  • An apparent increase in reporting within four days post-vaccination and a possible dose-response relationship were observed.
  • Forty-eight percent of cases involved imaging, and 69% required surgical intervention.

Conclusions:

  • The reviewed cases suggest a potential association between COVID-19 vaccination and appendicitis.
  • Causality cannot be established from this case series due to reporting biases.
  • Longitudinal global studies are necessary to definitively clarify any relationship between COVID-19 vaccines and appendicitis.
Keywords:
AppendicitisCOVID-19 vaccinePharmacovigilanceSafety signal

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