FOX31 Denver

J&J vaccine investigation underway after wave of adverse reactions at Commerce City site 

DENVER (KDVR) — New information has surfaced regarding the adverse reactions people had to the Johnson & Johnson vaccine in Commerce City.  

Eleven people reported having problems after getting the vaccine at the Dick’s Sporting Goods Park mass vaccination site on Wednesday.  

On Thursday, we learned the batch of J&J vaccines in question were part of what appeared to be one batch for Centura. 

Negative reactions from the J&J vaccine, also known as the Janssen vaccine, led to the temporary halt of the mass vaccination site in Commerce City.  

The doses were being administered by Centura Heath and the Colorado Department of Public Health and Environment.

“At this point we have no reason to believe there is anything wrong with the vaccine itself,” said Centura Health Chief Clinical Officer Dr. Shauna Gulley.  

Eleven people reported having adverse reactions out of 1,700 doses that were administered. Centura Health said two people were taken to a hospital out of an abundance of caution.  

Symptoms included light headedness, nausea, vomiting and low blood pressure. Those symptoms were mild according to Gulley.  

 “So, I think the vaccination was likely safe and effective for everyone who received it successfully,” added Gulley.  

The problems started around 11 a.m. Shots for 640 others waiting in line were cancelled four hours later and re-scheduled for Sunday.  

There have been 10 previous reactions documented at community vaccination sites across the state.

Eleven people having reactions in just a few hours was higher than what Centura had seen at any of its other sites.  

 “The issues yesterday that we experienced in partnership with the state will be fully investigated,” said Centura Health President and CEO Peter Banko.  

Johnson & Johnson told FOX31, the company is investigating and is “collecting the necessary information.” 

Meantime, other J&J vaccines were being administered at Ball Arena on Thursday.  

“We take very extreme precautions at these (vaccination sites). We need to make sure everything is ok and that all clear is there and everything is fine,” Governor Jared Polis said.  

Centura Health said the batch of vaccines in question has been sequestered. CDPHE is leading the investigation.  

“The Colorado Department of Public Health and Environment is in communication with the CDC and FDA regarding the temporary suspension of vaccinations at Dick’s Sporting Goods Community vaccination site yesterday and the Johnson & Johnson vaccine. We currently believe that the dizziness and other symptoms experienced are consistent with what can be expected of any similar medical procedure, however we are conducting an exhaustive review and are following up with patients from yesterday,” said a spokesperson for CDPHE.  

Centura Health encouraged everyone to move forward with taking their vaccines. The hospital system said there had been no cancellations.  

Below is the full statement from Johnson & Johnson.  

“There is no greater priority than the safety and well-being of the people we serve, and we carefully review reports of adverse events in individuals receiving our medicines and vaccines. Any report about individuals receiving our COVID-19 vaccine and our assessment of that report is shared with the U.S. Food and Drug Administration and other appropriate health authorities. This is part of the established process to inform health authorities’ comprehensive surveillance programs that monitor the overall safety of medicines, as well the vaccines authorized for use against this pandemic. We are collecting the necessary information, including from the local vaccination center, to assess these reports.”