CDC says no safety issues with J&J vaccine after NC clinic reports ‘adverse reactions’

RALEIGH, N.C. — The Centers for Disease Control and Prevention said it recommends continuing to give out the Johnson & Johnson vaccine after a North Carolina clinic stopped administering shots Thursday over “adverse reactions.”

According to Wake County officials, a vaccine clinic at the PNC Arena in Raleigh was put on hold around 3:30 p.m. after 18 people had “adverse reactions” to the Johnson & Johnson vaccine during the required 15-minute post-vaccination monitoring period.

Officials said 14 of those people had minor reactions and were treated on site. Four others were transported to area hospitals where they were evaluated. All but one have since been released, officials said.

According to the CDC, the patients experienced symptoms like nausea, dizziness, fainting and one allergic reaction.

Wake County health officials said all the reactions to the vaccinations were “consistent with known common side effects from receiving the vaccine.”

The CDC released a statement Thursday night saying it investigated the reactions and found no safety issues or reason for concern. The agency says it recommends continuing to administer doses.

“The North Carolina Department of Health and Human Services has worked with the Centers for Disease Control and Prevention (CDC) and Wake County Public Health Department to investigate a limited number of reactions that were reported during Johnson & Johnson vaccinations at PNC Arena on Thursday, April 8. Analysis by the CDC did not find any safety issues or reason for concern; and the CDC recommends continuing to administer the vaccine,” the statement read.

County officials said the decision to halt the clinic was made “out of an abundance of caution.”

A clinic in Orange County also made the decision to pause operations until an analysis was completed.

“We know it can be alarming to hear about or see people having reactions to vaccination -- this is why we closely monitor those we vaccinate in case of reaction,” said Wake County Public Health’s Medical Director Kim McDonald, “Right now we are working with NCDHHS and the CDC to further evaluate the situation to assure everyone is confident in the continued safety of our vaccine operations.”

More than 2,300 J&J vaccines were administered at the clinic on Thursday, according to county officials.

The North Carolina Department of Health and Human Services said there were not any reports of increased rates of reactions at any other provider.

CDC spokeswoman Kristen Nordlund said it is aware of adverse reactions in some people who received the vaccine shots in Iowa, Colorado, Georgia and North Carolina. Those reactions include dizziness, light headedness, feeling faint and rapid breathing.

She said the CDC is working with state and local officials to evaluate the issues and has performed vaccine lot analyses and not found reasons for concern. The CDC is not telling health departments to stop vaccinations.

“COVID-19 vaccines are safe and effective,” she said. “Many people don’t have any side effects after COVID-19 vaccines, but some people will have pain or swelling at the injection site or fever, chills, or a headache. These typically don’t last long and are signs that your body is building protection.”

David Wohl, an infectious disease expert at UNC Health who oversees the UNC vaccination sites, said between eight and 14 of the roughly 1,250 J&J vaccine recipients it injected on Thursday fainted after receiving the shot, though nobody was taken to a hospital.

Because of the timing of the day in which the adverse reactions started occurring, Wohl said UNC Health completed all shots for people who had appointments on Thursday at the two sites.

While his department is still working to analyze the source of the problem, he does not believe most of the cases stem from allergic reactions to the vaccine.

“I’m just concerned that if we have as many people fainting as we do, we need to understand why,” Wohl said. “Everyone that I’ve seen really doesn’t have an underlying medical history that’s of concern, but many of them do report having fainted previously.”

According to the Centers for Disease Control and Prevention, possible side effects of the one-dose vaccine are as follows:

In the arm where you got the shot:

• Pain
• Redness
• Swelling

Throughout the rest of your body:

• Tiredness
• Headache
• Muscle pain
• Chills
• Fever
• Nausea

The CDC says the side effects usually start within a day or two of getting the vaccine and that they might affect your ability to do daily activities, but should go away in a few days. Health officials said in most cases, temporary reactions are normal and are good signs that the body is building protection.

The CDC recommends the following prevention measures:

• Have a beverage or snack before getting your vaccine
• Sit or lie down after you receive your vaccine
• Breathe slowly and deeply before getting the vaccine and think of something relaxing

According to county officials, less than two hours of appointments were left at PNC Arena for the day when officials made the decision. Those remaining appointment holders were offered Pfizer vaccines or the opportunity to reschedule.

Full statement from NCDHHS on Wake County’s PNC clinic:

We are working with the Wake County Public Health team to investigate reactions to the Johnson & Johnson COVID-19 vaccine at an event at the PNC Arena today. Out of an abundance of caution, Wake County Health Department has paused use of the Johnson & Johnson vaccine at this event at this time. We have not had reports of other increased rates of reactions at any other provider, but will continue to investigate. We have notified Johnson & Johnson and are in contact with the Federal Government.

Vaccination providers are required by the FDA to report serious adverse events and encouraged to report other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. The CDC and FDA also encourages the public to report possible side effects (called adverse events) to the Vaccine Adverse Event Reporting System (VAERS). This national system collects data to look for adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns of occurrence. Reports to VAERS help the CDC monitor the safety of vaccines. Safety is a top priority.

Wake County’s full statement on PNC’s clinic:

Out of an abundance of caution, Wake County has paused Johnson & Johnson vaccinations at PNC Arena after a limited number of adverse reactions were reported at PNC Arena during the required post-vaccination monitoring period.

More than 2,300 J&J vaccines were administered at the PNC clinic today. Wake County EMS evaluated 18 total patients. Fourteen of those people had minor reactions and were treated on site. Four others were transported to area hospitals where they are being evaluated and are expected to be released.

Wake County made the decision to pause today in partnership with the NC Department of Health and Human Services and after consulting with the manufacturer. Together, these teams continue to investigate the issue. Currently the Centers for Disease Control and Prevention are analyzing the vaccine lot and expect to issue guidance within the next two hours.

Wake County is committed to providing safe community clinics, and it’s thanks to the 15-minute observation period adhered to at these sites that staff was able to provide immediate care.

The site is and will be prepared to respond to any adverse events.

Nationally, more than 4.5 million people have received the J&J vaccine. The reactions people experienced today were consistent with known common side effects from receiving the vaccine.

”We know it can be alarming to hear about or see people having reactions to vaccination - this is why we closely monitor those we vaccinate in case of reaction,” said Wake County Public Health’s Medical Director Kim McDonald, “Right now we are working with NCDHHS and the CDC to further evaluate the situation to assure everyone is confident in the continued safety of our vaccine operations.”

Less than two hours of appointments were left at PNC Arena for the day when officials made the decision. Today, those remaining appointment holders were offered Pfizer vaccines or the opportunity to reschedule until the evaluation is completed.

Wake County plans to hold and store any J&J vaccine until additional information is collected.

CDC’s full statement on Wake County’s PNC clinic:

The North Carolina Department of Health and Human Services has worked with the Centers for Disease Control and Prevention (CDC) and Wake County Public Health Department to investigate a limited number of reactions that were reported during Johnson & Johnson vaccinations at PNC Arena on Thursday, April 8. Analysis by the CDC did not find any safety issues or reason for concern; and the CDC recommends continuing to administer the vaccine.

Of more than 2,300 people who received the vaccine at the PNC event, 18 experienced symptoms like nausea, dizziness, fainting and one allergic reaction. Four were transported to local hospitals for observation; all but one have been released from the hospital. The CDC is aware of several incidents of vaccine recipients experiencing dizziness, light headedness, feeling faint (vasovagal) and rapid breathing, sweating, following COVID-19 vaccines in Iowa, Colorado, Georgia, and North Carolina.

People may experience temporary reactions after receiving a COVID-19 vaccine such as a sore arm, headache or feeling tired and achy for a day or two and in some cases, fever. In most cases, these temporary reactions are normal and are good signs that the body is building protection.

In addition, some people experience lightheadedness, nausea or fainting (symptoms of vasovagal syncope) after a vaccination. The CDC recommends the following prevention measures:

• Have a beverage or snack before getting your vaccine

• Sit or lie down after you receive your vaccine

• Breathe slowly and deeply before getting the vaccine and think of something relaxing

COVID-19 vaccines are tested, safe and effective. Close to 175 million COVID-19 vaccine doses have been administered in the United States. The three COVID-19 vaccines authorized by the Federal Food and Drug Administration are proven to help prevent COVID-19 and are effective in preventing hospitalizations and death. You cannot get COVID-19 from the vaccine, and there were no serious safety concerns found in clinical trials.

The CDC has created a smartphone-based tool called V-safe that checks in on people after their COVID-19 vaccination. After enrolling, users receive regular text messages directing them to surveys where to report any problems or adverse reactions. V-safe allows people to quickly tell CDC if they have any side effects after getting a COVID-19 vaccine. Depending on the answers to the web surveys, someone from CDC may call to check on the person and get more information.

In addition, anyone experiencing possible side effects (called adverse events) should report them to the Vaccine Adverse Event Reporting System (VAERS). This national system collects data to look for adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns of occurrence.

(The Associated Press contributed to this report.)

Gaston Co. expected to use part of Johnson & Johnson vaccine shipment to help homeless community

Cox Media Group