FAQs

Frequently Asked Questions

General Questions

The FDA and CDC wanted to evaluate a total of 15 rare events of cerebral venous thrombosis (a very rare type of clotting disorder) and low platelet count.  One of these people died; and another was hospitalized.  This syndrome (large vessel blood clots with low platelet count) was deemed to be biologically plausible to be associated with this type of vaccine.

The pause also afforded the opportunity to provide clarity to providers on a) who appears to be at increased risk and b) how to treat it appropriately if there is concern that it happened in someone who received the J&J vaccine.

The conclusion that they came to was that these rare events were in fact quite rare; and the benefits of the J&J vaccine greatly outweighed the risks of these events.

Category: J&J Vaccine Pause

The complication was a combination of a rare type of clotting disorder called a cerebral sinus venous thrombosis and a low platelet count.  

It is important to note that this is different from the regular blood clots we are used to thinking about.  In this case, the blood clot is the result of an immune-mediated phenomenon that causes destruction of the platelets (clotting cells) but also causes production of clots itself.  

The typical risk factors for blood clots are NOT associated with this type of clots.

Category: J&J Vaccine Pause

With only 15 of these outcomes, it’s very hard to tell if something is truly a pattern.  However, analysis did not find any particular risk factors other than all of the people who had this complication were women and the majority (13/15) were under the age of 50.

It is important to understand, however: this vaccine is NOT restricted from women or pregnant women.  It is just important to be aware of this potential rare risk.

Category: J&J Vaccine Pause

 Yes! And that is part of the reason pause: to really look at all the information and, if it is related, to get appropriate information back to health care providers about exactly what this is, what to look for, and how to appropriately treat it.

Category: J&J Vaccine Pause

This complication seems to happen a median of 9 days after vaccination—so it’s not an immediate side effect. And none of the cases occurred after 3 weeks of vaccination.

Symptoms include: severe headache, difficulty breathing, abdominal pain, swelling in the legs and easy bruising.  If you have had these symptoms and recently (within the last 3 weeks) had the J&J vaccine, you should contact your doctor or go to an emergency room to be evaluated.

Category: J&J Vaccine Pause

It is important to remember that this is an extremely rare side effect—6 people out of an estimated 7 million people who have received the J&J vaccine.  To put this into perspective, it is twice as rare as getting hit by lightening!

It is also important to remember that despite being so rare, the FDA and CDC still paused vaccination with the J&J COVID vaccine when seeing this.  This shows how seriously they take even rare serious side effects and how important it is for them to investigate these fully before allowing them to be given to Americans.

Category: J&J Vaccine Pause

Safety Questions

The FDA and CDC wanted to evaluate a total of 15 rare events of cerebral venous thrombosis (a very rare type of clotting disorder) and low platelet count.  One of these people died; and another was hospitalized.  This syndrome (large vessel blood clots with low platelet count) was deemed to be biologically plausible to be associated with this type of vaccine.

The pause also afforded the opportunity to provide clarity to providers on a) who appears to be at increased risk and b) how to treat it appropriately if there is concern that it happened in someone who received the J&J vaccine.

The conclusion that they came to was that these rare events were in fact quite rare; and the benefits of the J&J vaccine greatly outweighed the risks of these events.

Category: J&J Vaccine Pause

The complication was a combination of a rare type of clotting disorder called a cerebral sinus venous thrombosis and a low platelet count.  

It is important to note that this is different from the regular blood clots we are used to thinking about.  In this case, the blood clot is the result of an immune-mediated phenomenon that causes destruction of the platelets (clotting cells) but also causes production of clots itself.  

The typical risk factors for blood clots are NOT associated with this type of clots.

Category: J&J Vaccine Pause

With only 15 of these outcomes, it’s very hard to tell if something is truly a pattern.  However, analysis did not find any particular risk factors other than all of the people who had this complication were women and the majority (13/15) were under the age of 50.

It is important to understand, however: this vaccine is NOT restricted from women or pregnant women.  It is just important to be aware of this potential rare risk.

Category: J&J Vaccine Pause

 Yes! And that is part of the reason pause: to really look at all the information and, if it is related, to get appropriate information back to health care providers about exactly what this is, what to look for, and how to appropriately treat it.

Category: J&J Vaccine Pause

This complication seems to happen a median of 9 days after vaccination—so it’s not an immediate side effect. And none of the cases occurred after 3 weeks of vaccination.

Symptoms include: severe headache, difficulty breathing, abdominal pain, swelling in the legs and easy bruising.  If you have had these symptoms and recently (within the last 3 weeks) had the J&J vaccine, you should contact your doctor or go to an emergency room to be evaluated.

Category: J&J Vaccine Pause

It is important to remember that this is an extremely rare side effect—6 people out of an estimated 7 million people who have received the J&J vaccine.  To put this into perspective, it is twice as rare as getting hit by lightening!

It is also important to remember that despite being so rare, the FDA and CDC still paused vaccination with the J&J COVID vaccine when seeing this.  This shows how seriously they take even rare serious side effects and how important it is for them to investigate these fully before allowing them to be given to Americans.

Category: J&J Vaccine Pause

Timeline Questions

The FDA and CDC wanted to evaluate a total of 15 rare events of cerebral venous thrombosis (a very rare type of clotting disorder) and low platelet count.  One of these people died; and another was hospitalized.  This syndrome (large vessel blood clots with low platelet count) was deemed to be biologically plausible to be associated with this type of vaccine.

The pause also afforded the opportunity to provide clarity to providers on a) who appears to be at increased risk and b) how to treat it appropriately if there is concern that it happened in someone who received the J&J vaccine.

The conclusion that they came to was that these rare events were in fact quite rare; and the benefits of the J&J vaccine greatly outweighed the risks of these events.

Category: J&J Vaccine Pause

The complication was a combination of a rare type of clotting disorder called a cerebral sinus venous thrombosis and a low platelet count.  

It is important to note that this is different from the regular blood clots we are used to thinking about.  In this case, the blood clot is the result of an immune-mediated phenomenon that causes destruction of the platelets (clotting cells) but also causes production of clots itself.  

The typical risk factors for blood clots are NOT associated with this type of clots.

Category: J&J Vaccine Pause

With only 15 of these outcomes, it’s very hard to tell if something is truly a pattern.  However, analysis did not find any particular risk factors other than all of the people who had this complication were women and the majority (13/15) were under the age of 50.

It is important to understand, however: this vaccine is NOT restricted from women or pregnant women.  It is just important to be aware of this potential rare risk.

Category: J&J Vaccine Pause

 Yes! And that is part of the reason pause: to really look at all the information and, if it is related, to get appropriate information back to health care providers about exactly what this is, what to look for, and how to appropriately treat it.

Category: J&J Vaccine Pause

This complication seems to happen a median of 9 days after vaccination—so it’s not an immediate side effect. And none of the cases occurred after 3 weeks of vaccination.

Symptoms include: severe headache, difficulty breathing, abdominal pain, swelling in the legs and easy bruising.  If you have had these symptoms and recently (within the last 3 weeks) had the J&J vaccine, you should contact your doctor or go to an emergency room to be evaluated.

Category: J&J Vaccine Pause

It is important to remember that this is an extremely rare side effect—6 people out of an estimated 7 million people who have received the J&J vaccine.  To put this into perspective, it is twice as rare as getting hit by lightening!

It is also important to remember that despite being so rare, the FDA and CDC still paused vaccination with the J&J COVID vaccine when seeing this.  This shows how seriously they take even rare serious side effects and how important it is for them to investigate these fully before allowing them to be given to Americans.

Category: J&J Vaccine Pause

Vulnerable Population Questions

The FDA and CDC wanted to evaluate a total of 15 rare events of cerebral venous thrombosis (a very rare type of clotting disorder) and low platelet count.  One of these people died; and another was hospitalized.  This syndrome (large vessel blood clots with low platelet count) was deemed to be biologically plausible to be associated with this type of vaccine.

The pause also afforded the opportunity to provide clarity to providers on a) who appears to be at increased risk and b) how to treat it appropriately if there is concern that it happened in someone who received the J&J vaccine.

The conclusion that they came to was that these rare events were in fact quite rare; and the benefits of the J&J vaccine greatly outweighed the risks of these events.

Category: J&J Vaccine Pause

The complication was a combination of a rare type of clotting disorder called a cerebral sinus venous thrombosis and a low platelet count.  

It is important to note that this is different from the regular blood clots we are used to thinking about.  In this case, the blood clot is the result of an immune-mediated phenomenon that causes destruction of the platelets (clotting cells) but also causes production of clots itself.  

The typical risk factors for blood clots are NOT associated with this type of clots.

Category: J&J Vaccine Pause

With only 15 of these outcomes, it’s very hard to tell if something is truly a pattern.  However, analysis did not find any particular risk factors other than all of the people who had this complication were women and the majority (13/15) were under the age of 50.

It is important to understand, however: this vaccine is NOT restricted from women or pregnant women.  It is just important to be aware of this potential rare risk.

Category: J&J Vaccine Pause

 Yes! And that is part of the reason pause: to really look at all the information and, if it is related, to get appropriate information back to health care providers about exactly what this is, what to look for, and how to appropriately treat it.

Category: J&J Vaccine Pause

This complication seems to happen a median of 9 days after vaccination—so it’s not an immediate side effect. And none of the cases occurred after 3 weeks of vaccination.

Symptoms include: severe headache, difficulty breathing, abdominal pain, swelling in the legs and easy bruising.  If you have had these symptoms and recently (within the last 3 weeks) had the J&J vaccine, you should contact your doctor or go to an emergency room to be evaluated.

Category: J&J Vaccine Pause

It is important to remember that this is an extremely rare side effect—6 people out of an estimated 7 million people who have received the J&J vaccine.  To put this into perspective, it is twice as rare as getting hit by lightening!

It is also important to remember that despite being so rare, the FDA and CDC still paused vaccination with the J&J COVID vaccine when seeing this.  This shows how seriously they take even rare serious side effects and how important it is for them to investigate these fully before allowing them to be given to Americans.

Category: J&J Vaccine Pause
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