The state’s investigation into a woman’s death shortly after receiving a coronavirus vaccine ruled that the shot did not contribute to the fatality but she had COVID-19 and suffered other medical complications.
The family of Drene Keyes, a 58-year-old Gloucester resident who died in January, disputes that determination. They paid for an independent medical examination that Keyes’ daughter, Lisa Jones, says conflicts with the state’s findings.
The private investigation, which included an autopsy, indicated negative COVID-19 test results and evidence of a blood clot that investigators believed was linked to the administration of a COVID-19 vaccine, she said.
Keyes received a first dose of Pfizer vaccine Jan. 30 and died shortly after at VCU Tappahannock Hospital. A report documenting her case in the federal Vaccine Adverse Event Reporting System said she began having trouble breathing in the parking lot of her vaccination site about 20 minutes after getting the shot. She then began vomiting every 20 to 30 seconds.
Keyes was treated at the site with epinephrine shots in her leg and arm and medicine through an oxygen mask, according to the report. When medics transferred her to a stretcher to get her in an ambulance, she became unresponsive.
The state’s investigation, which did not include an autopsy, ruled she died naturally — of complications arising from hypertensive cardiovascular disease and COVID-19, according to the Office of the Chief Medical Examiner. Other significant conditions, it said, were Type 2 diabetes, high cholesterol, obesity and hypoventilation syndrome, a breathing disorder.
“The Office of the Chief Medical Examiner is unable to comment on the death of Ms. Keyes other than to confirm the cause and manner of death,” chief medical examiner Dr. William Gormley said in a statement released to The Virginian-Pilot on Friday. “Ms. Keyes did not experience an anaphylactic reaction. We continue to offer our heartfelt condolences to the family and friends of Ms. Keyes.”
Severe and sudden allergic reactions after COVID-19 vaccinations continue to be extremely rare, federal health officials say. Over 245 million shots were administered in the United States from mid-December through April. During that time, the federal surveillance system received 4,178 reports of death, or about 2-5 per million vaccinations. The existence of a report does not necessarily mean a vaccine caused the death, officials say.
In March, Jones said the family decided to get a private autopsy because the state did not perform one. At the time, her relatives hoped it would shed more light on what happened to Keyes, a church minister and supervisor for the Middle Peninsula Northern Neck Community Services Board.
“The examiner showed from the autopsy that there was a clot, bilateral pulmonary embolism, that they believe, in their medical opinion, resulted from medical treatment of the COVID vaccine, that led to her pulmonary edema,” she said. “And those were the direct cause of death.”
The private investigation, conducted by Epiarx Diagnostics, also took samples from multiple areas of Keyes’ respiratory tract, not just nasal pharyngeal swabs, Jones said. Those specimens showed negative results for COVID-19, from rapid and molecular PCR tests.
“It did give us comfort to know the truth, especially when we pretty much argued over and over again with the medical examiner to request that they do the autopsy, and they declined, every time,” she said.
The Virginia Department of Health declined to say if, when or how its COVID-19 tests were performed, stating it was protected health information.
It also has not received the family’s private autopsy report.
“We would be glad to review it,” said Tammie Smith, a health department spokeswoman.
How Virginia chose to investigate Keyes’ death will influence how federal agencies view the case. When the U.S. Centers for Disease Control and Prevention is alerted to a fatality through the surveillance system, for instance, it does not perform its own tests. Rather, the CDC looks at documents provided to it, such as hospital records, death certificates and autopsy reports.
The findings of a relationship between a vaccine and a fatal medical emergency rely on the opinions of those who treated and examined the patients.
In a previous statement from Gormley released through a spokeswoman two months ago, severe allergic reactions generally can be ruled out through blood work. When anaphylaxis — a severe allergic reaction — happens, itching, rash and swelling come on quickly and can obstruct the airway. During the inflammatory reaction, mast cells release a high level of an enzyme known as tryptase. If the deceased person’s tryptase level is normal, that person did not suffer a life-threatening allergic reaction.
Depending on the case, Gormley’s staff decide whether to conduct an autopsy. They choose “the least invasive procedures required to document the cause and manner of death and answer specific questions related to public safety,” according to a statement.
Emails obtained through the Freedom of Information Act reveal state employees’ discussions of her tryptase level. Though slightly elevated, Virginia pathologists did not think it was high enough to point to anaphylaxis.
On Feb. 4, five days after Keyes’ death, Dr. Chrystal Van Dusen, assistant chief medical examiner, told supervisors: “Review of medical literature indicates a postmortem level of >30 ug/L would be more concerning for an anaphylactic reaction.”
Their results showed a level of 15.7, she said.
For more information on COVID-19 vaccine safety monitoring, go to https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html.
Elisha Sauers, 757-839-4754, elisha.sauers@pilotonline.com
