Coronavirus (COVID-19) Update: July 13, 2021 – FDA.gov

For Immediate Release: July 13, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS. The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine: weakness or tingling sensations, especially in the legs or arms, thats worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

07/13/2021

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Coronavirus (COVID-19) Update: July 13, 2021 - FDA.gov