Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood fibrinogen, Blood fibrinogen decreased, Blood sodium, Computerised tomogram
Clinical narrative: ACUTE HEPATIC FAILURE; ACUTE KIDNEY INJURY; FIBRIN D DIMER; HEADACHE; BLOOD FIBRINOGEN DECREASED; ABDOMINAL PAIN; NAUSEA; VOMITING; PORTAL VEIN THROMBOSIS; HYPOXEMIA; DEEP VENOUS THROMBOSIS; PULMONARY EMBOLISM; HEPATIC VENOUS THROMBOEMBOLISM; SUSPECTED COVID 19 INFECTION; THROMBOCYTOPENIA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1862529) concerned a 46 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid, and concurrent conditions included: psoriatic arthritis, and gastroesophageal reflux disease, and other pre-existing medical conditions included: The patient had no known allergies. The patient was not pregnant at the time of vaccination. the patient had infected with COVID one month prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total administered on 27-OCT-2021 for an unspecified indication. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. Concomitant medications included esomeprazole magnesium, and secukinumab.  On 04-NOV-2021, the patient experienced portal vein thrombosis, abdominal pain, headache, nausea, vomiting.  On 09-NOV-2021, the patient went to hospital and found to have acute liver failure (Acute hepatic failure) acute kidney injury and thrombocytopenia. His D-dimer was 20 and had low fibrinogen. He also had Suspect portal vein thrombosis and possible Pulmonary embolism (PE). However was unable to get appropriate imaging due to renal injury. On the same day, patient had suspected covid 19 infection and had tested positive for Covid-19. On an unspecified date, the patient experienced hypoxemia, hepatic venous thromboembolism, pulmonary embolism, and deep venous thrombosis, and was hospitalized. On an unspecified date, the patient presented with headaches and petechiae who was found to be thrombocytopenic (PLT 21).  Laboratory data (dates unspecified) included: Alanine aminotransferase abnormal (NR: not provided) 1205, 2600, Aspartate aminotransferase (NR: not provided) 3300, 1477, Creatinine (NR: not provided) 2.00, Na+ (NR: not provided) 125, and Platelet count (NR: not provided) 23, 21.  The patient was eventually found to have bilateral LE (lower extremity) and hepatic VTEs (Venous thromboembolic events), and a saddle embolism with submissive PE. Oxygen requirements increased to 50L HFNC (High flow nasal canula). He received IVIG (intravenous immunoglobulin) and bivalirudin. After a 10 day hospitalization, patient's oxygenation improved to room air and he was discharged home. On an unspecified date, the patient's Computerized tomography results showed bilateral, near occlusive lobar pulmonary emboli with a component of saddle emboli. Small bilateral pleural effusions. Small amount of ascites and Heparin-induced thrombocytopenia test results showed positive with acute thrombus involving the middle hepatic vein and distal left hepatic vein. No opacification throughout the portal venous system. This was likely related to a combination of portal venous thrombosis and elevated portal venous pressures. Heterogeneous/decreased attenuation throughout the liver suggestive of chronic underlying hepatocellular disease, such as hepatic steatosis. No concerning arterially enhancing hepatic lesions. Portal venous hypertension, including splenomegaly and ascites. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombocytopenia, hypoxemia, and suspected covid 19 infection, had not recovered from abdominal pain, acute hepatic failure, acute kidney injury, blood fibrinogen decreased, fibrin d dimer, headache, nausea, portal vein thrombosis, and vomiting, and the outcome of hepatic venous thromboembolism, pulmonary embolism and deep venous thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  Additional information received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1862529) on 24-JAN-2022. The following information was updated and incorporated into the case narrative: events added (Suspected Covid- 19 infection, Hepatic Venous thromboembolism, Pulmonary embolism, hypoxemia, Deep Venous thrombosis,), outcome updated for the event thrombocytopenia, laboratory tests were added, Petechiae was subsumed under Thrombocytopenia, and AST(3300), ALT (2600) were subsumed under Acute Hepatic failure.; Sender's Comments: V1-The additional information in this version is events added (Suspected Covid- 19 infection, Hepatic Venous thromboembolism, Pulmonary embolism, hypoxemia, Deep Venous thrombosis,) outcome updated for the event thrombocytopenia, laboratory tests were added, Petechiae was subsumed under Thrombocytopenia, and AST(3300), ALT (2600) were subsumed under Acute Hepatic failure.This doesnot alter causality of previously reported events.  20211144795-COVID-19 VACCINE AD26.COV2.S-Deep venous thrombosis, pulmonary embolism, hepatic venous thromboembolism. Follow up received regarding clinical details. This event(s) is labeled per RSI and is therefore considered potentially related. 20211144795-COVID-19 VACCINE AD26.COV2.S-Hypoxemia, Suspected Covid- 19 infection. . Follow up received regarding clinical details. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0-20211144795-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia, portal vein thrombosis, abdominal pain, nausea, vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.  V0 20211144795-COVID-19 VACCINE AD26.COV2.S- acute hepatic failure, acute kidney injury, fibrin d dimer, headache, blood fibrinogen decreased. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).