Thrombocytopenia after Ad.26.COV2.S COVID-19 vaccine: Reports to the vaccine adverse event reporting system.

ABSTRACT:

Background

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for Ad.26.COV2.S COVID-19 vaccine. As part of post-authorization safety surveillance, the FDA has identified a potential safety concern for thrombocytopenia following receipt of Ad.26.COV2.S COVID-19 vaccine.

Methods

Reports of thrombocytopenia were identified in a passive reporting system (Vaccine Adverse Event Reporting System; VAERS) February-December 2021. Demographics, clinical characteristics, laboratory values, and relevant medical history were reviewed. The reporting rate was analyzed, including calculation of the observed-to-expected ratio based on vaccine administration data and the background rate of thrombocytopenia in the general (unvaccinated) populatio

SUBMITTER: Woo EJ 

PROVIDER: S-EPMC9149044 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature