On April 13, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended pausing use of the Janssen COVID-19 vaccine while they investigate reports of rare and serious blood clots in patients. Out of an abundance of caution and in keeping with strong safety measures used by VHA to protect Veterans who have been vaccinated with COVID-19 vaccines, VA has paused the use of this vaccine.
The pause is due to reports of six cases of the rare blood clots, all in adult women under 50, and all occurred within 6 to 13 days after the women received a Janssen (also known as Johnson & Johnson) vaccine. We want to emphasize this event is very rare. The CDC and FDA have been actively monitoring for possible reactions related to COVID-19 vaccines, and more than 6,800,000 doses of the Janssen vaccine have been given. The Veterans Health Administration has not had any reports of serious blood clots after COVID-19 vaccination and over 100,000 Veterans have received the Janssen vaccine.
The events that did occur were in the first two weeks after receiving the Janssen COVID-19 vaccine, so persons who received the vaccine more than two weeks ago would be considered even less likely to have this happen. The type of blood clot that occurred is called cerebral venous sinus thrombosis (CVST). It happens when a blood clot forms in a type of blood vessel in the brain. This can cause symptoms including headache, vision changes, or symptoms of a stroke. The people who have had this type of blood clot also have had low blood platelets.
Symptoms that occurred in those who developed this type of blood clot include a headache that occurs six days or more after vaccination, a headache that’s different from other headaches you have had, confusion or trouble thinking clearly, visual changes such as blurry vision, weakness, numbness, or trouble moving one or more parts of your body, trouble speaking or seizures, tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets).
If you received the vaccine in the last 2 weeks and develop the symptoms we have mentioned, please contact your VHA health care team or call 9-1-1 if symptoms are severe or if you have any of the following symptoms: shortness of breath, chest pain, leg swelling, persistent abdominal (belly) pain
CVST has not been observed in the other vaccines in use in the United States, namely the Pfizer-BioNTech and Moderna COVID-19 vaccines. Both of those vaccines are mRNA vaccines, which is a different type of vaccine than the Janssen COVID-19 vaccine.
For more information, visit https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html.