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# FDA Revises Janssen Vaccine Fact Sheets
- URL: https://www.fdaweb.com/fda-revises-janssen-vaccine-fact-sheets/
- Published: 2022-01-12T12:00:00.000Z
- Updated: 2026-09-14T17:28:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150909

FDA says it has revised the Janssen Covid-19 vaccine [fact sheet](http://www.fda.gov/media/146304/download?ref=fdaweb.com) for healthcare providers administering vaccines and the [fact sheet](http://www.fda.gov/media/146305/download?ref=fdaweb.com) for recipients and caregivers. The agency [says](https://www.fda.gov/news-events/press-announcements/fda-roundup-january-11-2022?ref=fdaweb.com) the revisions are in response to new safety information about the serious risk of immune thrombocytopenia, a disorder that can cause easy or excessive bruising and bleeding due to low levels of platelets following administration of the Janssen Covid-19 vaccine.

The revised provider fact sheet has information about reports of adverse events following the use of the vaccine that suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination, FDA says. It says individuals with a history of immune thrombocytopenia should discuss the risk and the potential need for platelet monitoring following vaccination with their healthcare provider.