Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Portal vein thrombosis, Thrombocytopenia
Clinical narrative: Portal vein thrombosis; Thrombocytopenia; ABDOMINAL PAIN; BLOOD TEST; HEADACHE; FEVER; CHILLS; This spontaneous report received from a health care professional via the Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) and from an online traditional media report, and concerned a 52 year old White (not Hispanic or Latino) male. The patient's weight and height were not reported. Concurrent conditions included migraines, hypothyroidism and fibromyalgia. The patient had no drug or food allergies, no illnesses in the month prior to vaccination, and no previous reaction to any vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1808980), dose was not reported, 1 total administered on 03-APR-2021 at 11:45 hours into the right arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium and ibuprofen. On an unspecified date, initially after vaccine administration, the patient experienced a fever, chills, and a headache.  Those mild symptoms subsided (date not specified).   At 03:00 hours on 13-APR-2021, the patient initially had a severe headache followed by abdominal pain. The patient was hospitalized (date not specified).  CT "found nothing out of the ordinary".  His blood platelet count appeared normal as well (no values provided), and unspecified blood tests were performed (no values provided).  The patient was then sent home. A few days later, the patient returned to the emergency room with severe abdominal pain.  His platelet count was significantly lower (no values provided).  He was diagnosed with portal vein thrombosis (fully blocked) via CT (computed tomography) scan, MRI (magnetic resonance imaging), and ultrasound scan (with and without contrast), and thrombocytopenia.  The initial treatment plan was a platelet transfusion, but the patient said his doctor called an "audible" after reading a medical paper, which indicated that the "vaccine-induced" blood clotting, combined with low platelet counts, was best treated with intravenous immunoglobulin (IVIG); the patient was treated as TTS (thrombosis-thrombocytopenia syndrome).  The patient was hospitalized for 5 days.  The patient has since been in and out of the hospital due to rising and falling platelet counts. He subsequently received a second IVIG treatment and his condition was monitored day-to-day. So far, he said doctors haven't figured out why his body is reacting this way. He suspects it has to do with his history of medical issues, dating back to his 20's when he dealt with "a lot of immune system problems" including chronic migraines, issues with his thyroid, and fibromyalgia, "combined with the vaccine".  The patient spent two months in and out of the hospital.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the portal vein thrombosis, thrombocytopenia, headache, blood test and abdominal pain was not reported.  The patient recovered from fever, chills, and the initial headache on an unspecified date.   This report was serious (Hospitalization Caused / Prolonged).  Additional information was received via an online media report on 03-JUN-2021.  Upon review, the following information was updated and incorporated into the case and case narrative: adverse events fever and chills were added as non-serious events, adverse event treatment medication, and additional details further explaining the adverse events.; Sender's Comments: V3: Additional information ragrding updates in non-serious adverse events, treatment medication, and details of previously reported adverse event did not alter prior assessment. This spontaneous report received from a health care professional from VAERS concerned a 52-year-old White male, not Hispanic or Latino, who was hospitalized for portal vein thrombosis and thrombocytopenia 10 days after Janssen COVID-19 vaccine Ad26.CoV2.S, was administered for prevention of symptomatic SARS-CoV-2 virus infection.  Concurrent conditions included migraines, hypothyroidism and fibromyalgia. The patient had no drug or food allergies, no illnesses in the month prior to vaccination, and no previous reaction to any vaccine. Concomitant medications included levothyroxine sodium and ibuprofen. The subject was hospitalized for 5 days and treated as "TTS" (Thrombosis with Thrombocytopenia Syndrome). The patient initially had a severe headache followed by abdominal pain, visited an emergency care facility, and was eventually diagnosed with fully blocked portal vein thrombosis following numerous blood tests, CT, MRI and ultrasound scans. Specific results were not provided. Outcome of the events was unknown. Based on evolving knowledge of TTS, per definition from Brighton Collaboration, the relationship of portal vein thrombosis and thrombocytopenia to vaccination is considered unclassifiable (BC Criteria level 4) due to insufficient information. Additional information is necessary for further assessment (specific platelet count levles, d-dimer, fibrinogen, antibodies to PF4 [ELISA if available], blood smear, specific results of imaging studies, results of COVID-19 test).