Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Constipation, Echocardiogram, Fibrin D dimer, Flow cytometry
Clinical narrative: Aortic mural thrombosis; SIRS; Acute kidney injury; Constipation; abdominal pain; This literature-non-study case was reported in a literature article and describes the occurrence of AORTIC THROMBOSIS (Aortic mural thrombosis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) and ACUTE KIDNEY INJURY (Acute kidney injury) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Obesity, Arteriovenous malformation (arteriovenous malformation in the brain) and Hyperlipidemia.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced AORTIC THROMBOSIS (Aortic mural thrombosis) (seriousness criterion hospitalization), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) (seriousness criterion hospitalization), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), CONSTIPATION (Constipation) and ABDOMINAL PAIN (abdominal pain). The patient was hospitalized on sometime in 2021 due to AORTIC THROMBOSIS. The patient was treated with ACETAMINOPHEN in 2021 at an unspecified dose and frequency; PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (PIPERACILLIN & TAZOBACTAM) in 2021 for Systemic inflammatory response syndrome, at a dose of 1 dosage form; VANCOMYCIN in 2021 for Systemic inflammatory response syndrome, at a dose of 1 dosage form; CEFEPIME in 2021 at an unspecified dose and frequency; HEPARIN in 2021 for Anticoagulant therapy, at an unspecified dose and frequency and WARFARIN in 2021 for Anticoagulant therapy, at an unspecified dose and frequency. At the time of the report, AORTIC THROMBOSIS (Aortic mural thrombosis) was resolving and SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS), ACUTE KIDNEY INJURY (Acute kidney injury), CONSTIPATION (Constipation) and ABDOMINAL PAIN (abdominal pain) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Angiogram: mural thrombus Although no pulmonary embolism was noted, a 1.3x0.8x0.7-cm mural thrombus was noted in the proximal descending thoracic aorta. On 03-Jun-2021, Angiogram: decrease in the size of the mural thrombus A repeat CT angiogram of the chest 1 week after the initial CT chest showed interval decrease in the size of the mural thrombus to 0.6x0.2x0.2 cm. On an unknown date, Antinuclear antibody: negative (Negative) Negative. On an unknown date, Antiphospholipid antibodies: negative (Negative) Negative. On an unknown date, Antithrombin III: negative (Negative) Negative. On an unknown date, Aspergillus test: negative (Negative) Negative. On an unknown date, Blood creatinine: 1.4 mg/dl 1.4 mg/dL with  baseline of 0.8 mg/dL. On an unknown date, Blood culture: no growth No growth even after 5 days. On an unknown date, Blood lactic acid (0.5-1): 5.7 mmol/l (High) 5.7 mmol/L. On an unknown date, Blood pressure measurement: 163/125 mm hg 163/125 mm Hg. On an unknown date, Body temperature: 104 f (High) febrile to T 104 F (40 C). On an unknown date, C-reactive protein: 64.3 mg/dl (High) 64.3 mg/dL (ref: less than 10 g/dL). On an unknown date, Chest X-ray: negative for cardiopulmonary abnormalities (Negative) negative for cardiopulmonary abnormalities. On an unknown date, Computerised tomogram: negative (Negative) A computed tomography (CT) scan of his abdomen and pelvis was ordered to investigate his nonspecific abdominal discomfort, which was negative.. On an unknown date, Echocardiogram: no evidence of endocarditis. no evidence of endocarditis.. On an unknown date, Fibrin D dimer (Unknown-<250 ng/ml): 840 ng/ml (High) D-dimer was elevated at 840 ng/mL. On an unknown date, Flow cytometry: negative for any abnormal cells (Negative) Flow cytometry was negative for any abnormal cells.. On an unknown date, Fungal test: no growth No growth even after 5 days. On an unknown date, Heart rate: 144 beats/min 144 beats/min. On an unknown date, Magnetic resonance imaging head: confirmed the stability did not show any other thrombotic events and confirmed the stability of his arteriovenous malformations (AVM). On an unknown date, Oxygen saturation: 98% on room air 98% on room air. On an unknown date, Platelet count (150000-450000): 250,000/micro l (normal) 250,000/micro L. On an unknown date, Procalcitonin (Unknown-< 0.1 ng/ml): 31.7 ng/ml (High) 31.7 ng/mL. On an unknown date, Protein C: negative (Negative) Negative. On an unknown date, Protein S: negative (Negative) Negative. On an unknown date, Red blood cell sedimentation rate: 12 mm/h (normal) normal sedimentation rate of 12 mm/h.. On an unknown date, SARS-CoV-2 RNA: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative. On an unknown date, Troponin I (Unknown-< 0.04 ng/ml): undetectable undetectable and 0.090 ng/ml The second troponin was elevated at 0.090 ng/mL and subsequently trended down.. On an unknown date, Ultrasound Doppler: deep vein thromboses in extremities. Doppler ultrasounds ruled out deep vein thromboses in extremities.. On an unknown date, White blood cell count (4500-11,000): 3400/microl (Low) leukopenia - 3400/micro L with bandemia of 14%. On an unknown date, White blood cell scan: infectious or inflammatory etiology tagged white blood cell scan that showed only a mild focal increased uptake at the mural thrombus in the proximal descending aorta, which represented infectious or inflammatory etiology..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AORTIC THROMBOSIS (Aortic mural thrombosis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS), ACUTE KIDNEY INJURY (Acute kidney injury), CONSTIPATION (Constipation) and ABDOMINAL PAIN (abdominal pain) to be related.    Patient  presented for a 1-day history of high fevers, shaking, chills, shortness of breath, and Palpitations after he received his second mRNA-1273 SARS-CoV-2 vaccine 30 hours prior. Few hours after vaccine administration, the patient initially began to experience arm soreness, fevers, headache, and body aches, but these symptoms improved with acetaminophen. However, the next day, patient began to experience the acute onset of the above presenting symptoms and presented to the hospital.  Patient's blood work revealed bandemia of 14%. Patient also presented persistent tachycardia. Differentials, as per the radiologist, included emboli versus infected thrombus. Laboratory tests included (1-3)-b-D-glucan infectious workup which was negative, Factor V Leiden and prothrombin gene mutation hypercoagulability workup was negative. Patient was anticoagulated with heparin initially and bridged to warfarin after achieving a therapeutic INR. Antibiotics were stopped. Having ruled out infection, inflammatory, and hypercoagulable etiologies, authors presumed that this aortic mural thrombus could be a rare sequela of the second mRNA-1273 SARS-CoV-2 vaccine. The probability of the Naranjo adverse drug reaction was 5, indicating probably adverse drug reaction. Patient had an initial follow-up with hematology approximately 1 month after this presentation and was advised to take anticoagulation for 36 months with no requirement for lifelong anticoagulation. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow up received by safety on 19-MAY-2022 has Email and contains significant information: Reporter information, literature information, relevant history, laboratory data, treatment and events were updated.  Company comment: This literature-non-study case concerns a 49-year-old male patient with Obesity and Hyperlipidemia reported, who experienced the unexpected serious adverse events of special interest Aortic thrombosis (Aortic mural thrombosis), Systemic inflammatory response syndrome, and Acute kidney injury on an unknown date after receiving mRNA-1273 COVID 19 vaccine as second dose in the COVID-19 vaccination series that led to hospitalization. Patient initially had fever, chills, headache, and body aches that improved with acetaminophen intake. The same symptoms along with palpitations, shortness of breath, abdominal pain, and constipation were experienced by the patient the following day prompting emergency room visit where his vital signs showed tachycardia (144 bpm), elevated temperature (40C), and elevated blood pressure of 163/125 mmHg. Oxygen saturation was 98, blood tests showed leukopenia with bandemia, elevated creatinine and lactate. Patient was started on PiperacillinTazobactam and Vancomycin and was admitted.  Subsequent workup revealed elevated C reactive protein, procalcitonin, D-dimer, and elevated Troponin I (second take).  CT angiogram of the chest revealed a 1.3x0.8x0.7 cm mural thrombus in the proximal descending thoracic aorta. Patient was treated with heparin and bridged to warfarin.  Repeat CT angiogram a week later showed decrease in the size of mural thrombus. Obesity and Hyperlipidemia could be considered as predisposing and contributory factors to the development of Aortic thrombosis and Acute kidney injury.  No information was provided on the first dose of COVID-19 vaccination.  The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 49-year-old male patient with Obesity and Hyperlipidemia reported, who experienced the unexpected serious adverse events of special interest Aortic thrombosis (Aortic mural thrombosis), Systemic inflammatory response syndrome, and Acute kidney injury on an unknown date after receiving mRNA-1273 COVID 19 vaccine as second dose in the COVID-19 vaccination series that led to hospitalization. Patient initially had fever, chills, headache, and body aches that improved with acetaminophen intake. The same symptoms along with palpitations, shortness of breath, abdominal pain, and constipation were experienced by the patient the following day prompting emergency room visit where his vital signs showed tachycardia (144 bpm), elevated temperature (40C), and elevated blood pressure of 163/125 mmHg. Oxygen saturation was 98, blood tests showed leukopenia with bandemia, elevated creatinine and lactate. Patient was started on PiperacillinTazobactam and Vancomycin and was admitted.  Subsequent workup revealed elevated C reactive protein, procalcitonin, D-dimer, and elevated Troponin I (second take).  CT angiogram of the chest revealed a 1.3x0.8x0.7 cm mural thrombus in the proximal descending thoracic aorta. Patient was treated with heparin and bridged to warfarin.  Repeat CT angiogram a week later showed decrease in the size of mural thrombus. Obesity and Hyperlipidemia could be considered as predisposing and contributory factors to the development of Aortic thrombosis and Acute kidney injury.  No information was provided on the first dose of COVID-19 vaccination.  The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine is not affected by this report.