Healthy Father of 7 Suffers Brain Blood Clot and Is Paralyzed After J&J Vaccine
Brad Malargarie, of St. Martin, Mississippi, is a 43-year-old father of seven who, like so many, decided to get the COVID-19 vaccine.
The young father got the Johnson & Johnson single-dose Janssen injection, and four hours later was found slumped over and unresponsive at work.
He suffered a stroke caused by a blood clot in his left middle cerebral artery in his brain, which has left the young father paralyzed on one side of his body and unable to talk.
This is the exact kind of blood clot that caused the J&J vaccine to be paused last week, but the FDA and CDC have lifted the pause.
According to the FDA:
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.
However, the clinical trial of 21,895 vaccine recipients uncovered this very rare blood clot.
A healthy 25-year old male with no past medical history in the Janssen trial experienced a transverse sinus thrombosis, which was the brain blood clot that would get the vaccine paused. And the initial investigator totally dropped the ball, deeming it not related.
Here is the detailed description reported in the J&J Janssen clinical trial:
A 25-year-old male with no past medical history and no concurrent medications experienced a transverse sinus thrombosis on Day 21 following vaccination. On Day 9 the participant experienced symptoms of fever, myalgia, headache, fatigue, abdominal pain, congestion and rhinorrhea. He tested negative for SARs-CoV-2 during this acute illness. Aside from headache, his symptoms improved. On Day 19 he experienced atonic colonic seizure. A CT scan without contrast demonstrated a cerebral hemorrhage. On Day 21, a transverse sinus thrombosis was reported on a venogram. The participant underwent a thrombectomy as well as stent placement for stenosed right sigmoid sinus on Day 22. On Day 23 repeat venogram showed the presence of a new clot in the transverse sinus. A second thrombectomy with venoplasty was performed. Treating clinicians reported observing rapid thrombus formation during the two thrombectomy procedures that was consistent with a clinically hypercoagulable state. In their assessment, the transverse sinus thrombosis most likely occurred days before the participant’s clinical presentation with a seizure; the seizure was reported to be a consequence of a secondary bleed caused by elevated venous pressure from the venous flow obstruction. Workup for hematologic and infectious causes of the thrombosis did not reveal an etiology. This event was initially thought to be related to the study product by the investigator and prompted a study pause. After thorough investigation and expert consultation no clear cause of the event was identified; however possible contributing factors, such as preceding infection and an anatomical anomaly, were suggested. The investigator’s brochure and informed consent form were updated accordingly, and the study pause was lifted. The investigator and Sponsor’s final assessment of this event was that it was not related to the study product.
As of April 22nd, 8 million people were vaccinated with the Janssen shot, putting the total number of this rare brain blood clot to be around 365.
Brain Blood Clots May Have Affected 365 People–Not 6
Numerical imbalances, with more events in vaccine than placebo recipients, were observed for the following serious and other adverse events of interest in individuals receiving the vaccine or placebo, respectively:
- Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs. 2 events (1 serious; 2 within 28 days of vaccination).
- Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event (serious and within 28 days of vaccination).
- Transverse sinus thrombosis: 1 event (serious and within 28 days of vaccination) vs. 0.
- Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and 0 within 28 days following vaccination).
- Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) vs. 0.