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We concur with the updates to the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the following new information, changes and clarifications:
5 WARNINGS AND PRECAUTIONS
• In Section 5.2 Thrombosis with Thrombocytopenia: The sentence “Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal.” was deleted and replaced with “The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some have been fatal.”
• Subsection ‘5.3 Guillain-Barré Syndrome’ including the following information was added: Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
6 OVERALL SAFETY SUMMARY
• The sentence “Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein, lower extremity veins, and pulmonary artery, with thrombocytopenia have been reported following the Janssen COVID-19 vaccine.” was deleted.
• The following was added to this section: “Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.”

6.2 Post Authorization Experience
The sentence “Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein, lower extremity veins, and pulmonary artery, combined with thrombocytopenia" was deleted
• The following was added to this section: Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
o BloodandLymphaticSystemDisorders:Thrombosiswiththrombocytopenia
o ImmuneSystemDisorders:Allergicreactions,includinganaphylaxis
o NervousSystemDisorders: Guillain-Barrésyndrome
o VascularDisorders:Capillaryleaksyndrome,Thrombosiswiththrombocytopenia
https://www.fda.gov/media/150723/download