most side effects are not serious

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(CNN) – A new review of monitoring data to assess the safety of the Johnson & Johnson COVID-19 vaccine found that only 3% of reported reactions after receiving the injection are classified as severe. In addition there were a total of 17 cases of severe blood clotting with low levels of platelets in the blood.

The report, published this Friday by the Centers for Disease Control and Prevention (CDC, for its acronym in English), notes that the safety profile of the vaccine, so far, has been similar to that observed. in clinical trials, but safety assessment during vaccine deployment quickly identified cases of blood clots.

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“The United States Vaccine Safety Monitoring System quickly detected a rare but serious adverse case that occurs primarily in women, blood clots in large vessels accompanied by a low platelet count,” the CDC researchers wrote. in the report. “Monitoring for common and rare adverse events continues after receiving all covid-19 vaccines, including the Janssen COVID-19 vaccine.”

Janssen is the vaccine division of Johnson & Johnson. In February, the Johnson & Johnson vaccine was licensed for emergency use in the United States. Use of the vaccine was temporarily halted in mid-April due to extremely rare but serious cases of blood clotting in the cerebral venous sinuses after receiving the vaccine. The hiatus was lifted last week.

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Cases of clots in the US after the Johnson & Johnson vaccine

The new CDC report summarized the most recent vaccine safety data, which includes 13,725 incidents reported through the agency’s Vaccine Adverse Reaction Reporting System (VAERS). The data showed that 97% of the events were not serious.

In total, 17 cases were reported consistent with what has been described as thrombosis with thrombocytopenia syndrome or blood clotting with low levels of platelets in the blood, including 14 that were cerebral venous sinus thrombosis and three that did not involve the venous sinuses of the brain between women under the age of 60 during the vaccine break, according to the report.

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The data also included 88 deaths reported after vaccination. Among those deaths, three occurred in patients with cerebral venous sinus thrombosis, and the CDC researchers wrote that, after conducting preliminary reviews, “no other deaths appear to have an association with the vaccine.”

Cases of anxiety

Additional new data released Friday by the CDC suggests that Johnson & Johnson’s administration of the COVID-19 vaccine in early April may also have been linked to a higher incidence of “anxiety-related events” in the waiting period. 15 minutes after receiving the vaccine.

All of these anxiety-related events occurred before the reports of thrombosis with thrombocytopenia syndrome related to the Janssen vaccine came out.

In a study published Friday in the CDC’s Morbidity and Mortality Weekly Report, researchers examined data from five mass vaccination sites that reported an increase in anxiety-related events, including a rapid heart rate and rapid breathing and fainting after death. Johnson & Johnson’s Covid-19 Vaccine Administration April 7-9.

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The researchers counted a total of 64 anxiety-related cases in 8,624 vaccine recipients. The syncope or fainting rate was found to be 8.2 per 100,000 doses administered, which is 164 times the fainting rate reported after receiving the flu vaccine, the researchers wrote.

All cases were reported to the Vaccine Adverse Reaction Reporting System and none were considered “serious” by VAERS standards. More than half of the reported fainting spells were in women. At four of the five sites observed, these events occurred on the first day of the administration of the Janssen injection.

The study authors suggested that because Janssen’s covid-19 vaccine is a single-dose injection, people with fear of needles may be more likely to receive this injection rather than the other two-dose options. Of all the fainting cases, 20% of those reported occurred in people who had reported to the vaccination site that they had a history of aversion to needles.

Fainting of young people

Half of the reports of fainting occurred in people between the ages of 18 and 29. Fainting associated with injections is more common in teens and young adults. The researchers cited similar rates of fainting in the administration of the human papillomavirus vaccine, which is given mainly to young people. The HPV vaccine has a fainting rate of 7.8 per 100,000.

The researchers said tracking anxiety case rates will be important information for healthcare providers as the Covid-19 vaccine reaches more and more young people.

“Anxiety-related events can occur after any vaccine,” the study authors wrote.

“It is important that vaccination providers are aware that anxiety-related adverse events may occur more frequently after receiving the Janssen covid-19 vaccine than after influenza vaccination and should observe all recipients of the covid-19 vaccine for any adverse reaction for at least 15 minutes after the administration of the vaccine, ”they wrote. “As the use of COVID-19 vaccines expands to younger age groups, providers should be aware that younger people may be more predisposed than older people to post-pregnancy anxiety-related cases than older people. vaccination”.

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