“WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME ...
The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening.
TTS may involve thrombosis at unusual locations for a thrombus (i.e., cerebral vein, visceral artery or vein, extremity artery, central artery or vein) or in an extremity vein or pulmonary
artery.
Among reported cases of TTS following administration of the Janssen COVID-19 Vaccine, symptoms began approximately one to two weeks after vaccination...
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the ‘Vaccine Information Fact Sheet for Recipients and Caregivers’ (and provide a copy or direct the individual to the website www.janssencovid19vaccine.com to obtain the Fact Sheet) prior to the individual receiving the Janssen COVID-19 Vaccine, including:
- FDA has authorized the emergency use of the Janssen COVID-19 Vaccine, which is not an FDA-approved vaccine.
- There is an option to accept or refuse the Janssen COVID-19 Vaccine.
- The significant known and potential risks and benefits of the Janssen COVID-19 Vaccine, and the extent to which such risks and benefits are unknown."
As of August 18, 2023, the original link to this document has been marked as "Revoked": https://www.fda.gov/media/146304/download