Over 6.8 million Americans have received the Johnson & Johnson COVID-19 vaccine, which is now facing renewed scrutiny after six of those recipients developed a rare, severe type of blood clot that has caused the FDA and Centers for Disease Control and Prevention (CDC) to recommend a pause in the rollout. But for those millions who have already received the one-shot vaccine, what does that mean?
According to the FDA, all six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days post-vaccination. The blood clot, called cerebral venous sinus thrombosis, which was seen in combination with low levels of blood platelets, is treated differently than other clots.
As such, the agency now recommends that people who have received the Johnson & Johnson vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after inoculation contact their health care provider.
Health care providers are also being asked to report such adverse events to the Vaccine Adverse Event Reporting System. The agency said the pause is also meant to inform the health care community so that they can better prepare for the potential occurrence of these clots, and “plan for proper recognition and management due to the unique treatment required.”
“Right now, these adverse events appear to be extremely rare,” the FDA said. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”