Diane Spears felt woozy and lethargic for hours after receiving the single-shot Johnson & Johnson COVID-19 vaccine on March 27, and it only got worse from there.

Doctors at two hospitals in Oxford, Pennsylvania, diagnosed the woman with a blood-clot-induced stroke, but it was too late. She passed away on April 6.

Spears, 68, had never had a stroke and had no known heart problems. Her husband, James Spears, believes she is one of the very few people who developed blood clots and suffered a stroke after receiving the J&J vaccine. After receiving reports of adverse events, the Food and Drug Administration and the Centers for Disease Control and Prevention halted the J&J vaccine in April before deciding that the benefits outweighed the risks of keeping it off the market. The FDA and CDC identified 48 cases of people developing blood clots and low platelet counts after receiving more than 15.5 million doses of the vaccine as of Oct. 27. This condition is known as thrombosis with thrombocytopenia syndrome.

Several studies have shown that vaccines are safe and effective, with few serious side effects. Through November 1, more than 423 million doses of COVID-19 vaccine were administered in the United States, reports of death remain extremely rare, just .0022% of doses administered. And reports collected through the Vaccine Adverse Event Reporting System, a joint CDC-FDA reporting database, do not always indicate that a vaccine was the cause of death.

Following Diane Spears’ death in July, an attorney for her family’s attorney filed a claim with an obscure federal program that compensates people for serious side effects from vaccines, drugs, and other treatments. People who file a claim for injury under the program, on the other hand, face an uphill battle in getting a favorable decision.

Even before COVID-19 vaccines became widely available in the United States, the federal Countermeasures Injury Compensation Program rejected more than 90 percent of nearly 500 claims. Since then, the program run by the Health Resources and Services Administration has seen a fivefold increase in claims for COVID-19 vaccines and treatments.

Spears’ case is one of 3,158 claims filed since the beginning of the pandemic alleging injuries from COVID-19 interventions. One thousand three hundred of those claims allege injuries or deaths as a result of the COVID-19 vaccine.

So far, no claims have been paid, and only two vaccine cases have been rejected. One claim that was denied claimed that the vaccine caused swelling of the tongue and throat, difficulty speaking, swallowing, and dizziness. The other claimed the vaccine resulted in a permanent shoulder injury.

People seeking compensation must meet a high standard of proof under the countermeasures program. It is not enough for someone to sustain an injury as a result of receiving the vaccine or treatment. The injured person or their family must provide proof that the injury was caused directly by a vaccine or treatment.

Since 2010, the program has paid out more than $6 million in claims. Ten cases were eligible for compensation but had no out-of-pocket expenses.

Families who have filed claims, as well as attorneys representing them, claim that the program does not provide timely compensation or responses. David Carney, a Philadelphia attorney who represents people claiming injury from COVID-19 vaccines and other vaccines, did not expect such a large number of pending claims nearly a year after the new vaccines were released.

Because vaccine mandates are becoming more common, Carney and others believe it is critical to have a fair arbiter of rare injuries. Last week, the Biden administration announced that employees at larger companies must be vaccinated by January 4 or be routinely tested for the coronavirus. Approximately 17 million health care workers in hospitals, nursing homes, and other clinics have been required to get the shot or face fines or sanctions from their employers. As a result, some employers in the health care industry have fired or suspended vaccine skeptics.

The Vaccine Injury Compensation Program, also known as vaccine court, handles the majority of routine vaccine injury claims by holding hearings before independent “special masters.” Consumers have three years to file a claim, and the court will pay for their attorneys’ fees and expert medical opinions.