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Background/Aim Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen are the 3 COVID-19 vaccines authorized for emergency use in the United States. This study aims to analyze and compare adverse events following immunization associated with these COVID-19 vaccines based on Vaccine Adverse Effect Reporting System data. Methods We utilized Vaccine Adverse Effect Reporting System data from January 1, 2021 to April 30, 2021 to analyze and characterize adverse effects postvaccination with these authorized COVID-19 vaccines in the US population. Results A total of 141,208 individuals suffered at least one adverse events following immunization following 239.97 million doses of COVID-19 vaccination. The frequency of side effects was 0.04%, 0.06%, and 0.35% following administration of Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen vaccines, respectively. Most of the patients had mild systemic side effects, the most common being headache (0.01%) and fever (0.01%). The frequency of serious side effects including anaphylaxis (0.0003%) and death (0.002%) was extremely low. Conclusions The three COVID 19 vaccines have a wide safety profile with only minor and self-limiting adverse effects. However, continued monitoring and surveillance is required to review any unexpected serious adverse effects.

CD20-negative diffuse large B-cell lymphoma (DLBCL) is a rare entity and constitutes 1-2% of all DLBCLs. Major subtypes include plasmablastic lymphomas (PBLs), primary effusion lymphomas, anaplastic kinase positive large B-cell lymphomas, and large B-cell lymphomas arising in human herpesvirus 8 (HHV8)-associated multicentric Castleman disease. Amongst the known subtypes, PBL is the most common and presents as an aggressive extranodal disease with high resistance to routine chemotherapy regimens, thereby posing a therapeutic challenge. Though more commonly seen in HIV-positive patients, PBL cases have also been reported in HIV negative patients. We report a unique case of PBL with pelvic organ involvement in an HIV/Epstein-Barr virus-negative patient. The neoplastic cells were found to be positive for CD79a, MUM1, BCL6, and PAX5, with a Ki-67 proliferation index of 92%. Our case met the criteria for the plasmablastic variant, and remission was obtained with etoposide, vincristine, and doxorubicin with bolus doses of cyclophosphamide and oral prednisone (EPOCH) therapy. This case report aims to highlight the challenges related to the diagnosis and treatment of CD20-negative DLBCL, with special emphasis on the PBL subtype and to provide an insight into some of the upcoming, less conventional treatment modalities.

Background Multiple risk factors have been linked to venous thromboembolism (VTE). It is well established that elevated level of homocysteine correlated with increased risk of VTE. Some studies showed that vitamin B12 deficiency may be the cause for homocysteinemia. Therefore, it is recommended by some groups that vitamin B12 should be supplemented in the patient with high homocysteine to prevent VTE. However, more recent study has shown that there is correlation between the high serum Vitamin B12 level and risk of VTE in cancer patients.[1] provoked VTE after orthopedic surgery was also shown to be associated with elevated vitamin B12 serum levels in elderly patients. The role of vitamin B12 in VTE patients is not fully understood. Our study is to see whether there is correlation between serum Vitamin B12 level and risk of VTE in general population. Methods 177 Patients admitted to Kingsbrook Jewish Medical Center between January 1st, 2015 to December 31st, 2018 with the diagnosis of VTE were identified. 95 cases had measured serum Vitamin B12 results within 3 months. 97 patients without any history of VTE who were seen in the hematology clinic during the same period time were used as control in this study. Demographic information and Vitamin B12 level were collected. T test and chi-square were used for statistical analysis. Results VTE patients had a median age of 70, which is significantly higher than the median age of 57 in the control group. The mean level of vitamin B12 in control group was 620 pg/mL, which was lower than the average vitamin B12 level (770 pg/mL, p=0.0344) in the VTE group. When we divided the patients into 3 groups based on Vitamin B12 level: Low B12 (800 pg/mL). We observed 41% of VTE patients have B12 level more than 800 pg/mL while only 20% of control patients have high B12 level (chi-square, p=0.006). Discussion Our study showed that vitamin B12 level is significantly elevated in patients diagnosed with VTE and more than 40% of those patients actually have vitamin b12 level more than 800 pg/mL. It is known that elevated vitamin B12 level is associated with inflammation and increased mortality.[2] An association between elevated B12 levels and cancer has been reported in several studies [3]. It is unclear elevated vitamin B12 levels predict undiagnosed cancer which is a known risk factor for VTE or vitamin B12 directly contribute hypercoagulation. Nevertheless, we should be cautious when supplementing vitamin B12 and the dosage may need to be titrated closely. More clinical studies are definitely warranted. References 1. Arendt JFH, el al. Elevated plasma vitamin B12 levels and risk of venous thromboembolism among cancer patients: A population-based cohort study. PubMed ID: 26724465 2. Grossfeld A1, et al. Symptomatic venous thromboembolism in elderly patients following major orthopedic surgery of the lower limb is associated with elevated vitamin B12 serum levels. PubMed ID:23000313 3. Johan F.H. Arendt, Henrik T. Sørensen, Laura J. Horsfall and Irene Petersen. Elevated Vitamin B12 Levels and Cancer Risk in UK Primary Care: A THIN Database Cohort Study. EPI-17-1136 Published April 2019 Disclosures No relevant conflicts of interest to declare.

Hemoperitoneum due to spontaneous rupture of hepatocellular carcinoma is a life-threatening and rare condition in western countries with an incidence of less than 3% because of early detection of cirrhosis and neoplasm. Here, we describe a case of a 66-year-old male patient with altered mental status with hemorrhagic shock. Computed tomography scan of abdomen revealed hemoperitoneum and mass in liver. Patient underwent resection of liver tumor and biopsy revealed multinodular hepatocellular carcinoma. A high degree of suspicion is required where severe anemia and hemoperitoneum can be a first presentation for hepatocellular carcinoma especially in patients with chronic hepatitis C infection. Early diagnosis is crucial since mortality rates remain high for untreated cases.

Patients with cervical adenopathy suspicious for malignancy are often referred to the Otolaryngology Service for tissue diagnosis. Confirmation of nodal involvement by upper aero-digestive tract tumors (UADT) is best obtained by fine needle aspiration (FNA). Reported studies of FNA for lymphoma diagnosis have yielded conflicting results. Retrospective review of charts and pathology of 161 patients diagnosed with lymphomas yielded 53 patients with cervical adenopathy without apparent UADT. FNA's were performed on 28, and were repeated nine times, for a total of 37. Eleven had Hodgkin's disease and 17 other types of lymphomas. Seven of 37 specimens contained only blood; 15 contained lymphoid cells, nine of which were designated "reactive." Lymphoid cells designated as "atypical" or "suspicious for lymphoma" were found in 13 of the 37 aspirates. Two were diagnostic of lymphoma. Lymphoma was confirmed by histopathologic specimens in all patients, obtained 0-941 days (median 15, mean 73 days) after initial FNA. In lymphoma patients with cervical lymphadenopathy, FNA does not usually suffice for, and often leads to significant delays in diagnosis.

e21546Background: The American Cancer Society reports that a quarter of cancer patients may suffer from depression. While depression is often under-diagnosed in the general population, the rate of ...

e14690 Background: K-ras mutation in CRC is known to occur in around 40% of the general population. It implies a poor prognosis, and resistance to anti- EGFR monoclonal therapy. The incidence of Kras mutation in African American (AA) patients with CRC is not known. Methods: Records of patients treated for CRC at Kings County Hospital and Downstate Hospital; in Brooklyn from 2005-12 were reviewed. Results: Of 116 patients’ records, 90 were informative for presenting stage, K-ras expression or both; all but one were AA, and 60 of 90 (67%) were male. Their ages ranged from 36 to 86 (median 64) years. The stages at presentation were known in 76; 3% were stage I, 17% stage II, 35% stage III and 45% stage IV. Follow-up periods ranged from 14 to 2381 days (median 409). K-ras mutation analysis was performed by a single commercial laboratory in 68 patients who had, or were suspected of having advanced disease. Codons 12 and 13 in K-ras exon 2 were analyzed. Of these 68 patients 31 (45%) bore K-ras mutations. K-ras mutation status was known in 9 stage I and II pts, and 6 of 9 pts (67%) bore mutations. After 233-967 days follow-up (median 474) 8 of 9 patients were alive. The 3 pts with wild type K-ras were a median of 70 years of age, 67% were female, and all were alive at median of 266 days (range 239-122-) follow up. Of the 16 stage III patients whose K-ras was analyzed, 7 (44%) were mutated. These 7 pts were a median of 66 years of age, and 86% were male. After 398 days median follow up 57% had relapsed and 45% had died. The 9 stage III pts with wild type K-ras were a median of 70 years of age and 78% were male. After a median follow up of 600 days, 2 were relapse-free, 7 had relapsed and 6 had died. Of the 34 stage IV pts, K-ras was analyzed in 29 and mutated in 12 (41%). Of the mutated patients, 83% were female and the median age 57. Their median survival was 557 days (56-1627). The 17 pts with wild type K-ras were 67% female with a median age of 59. Their median survival was 711 days (25-2040). The presenting CEA levels were similar in wild type and mutated patients. Conclusions: The prevalence of K-ras mutations, and the better prognosis of wild type K-ras in advanced CRC in AA patients, is similar to that of the general American population. The relapse rate of stage 3 AA patients seems higher in both wild type and mutated pts.

e15097 Background: RCC is a surgically curable malignancy; the outcomes are typically based on tumor size/extent and histology. Partial nephrectomy (PN) is preferred as nephron sparing approach over radical nephrectomy (RN), especially in smaller tumors. Methods: We reviewed data from Surveillance, Epidemiology, and End Results (SEER) 17 Regs Research Data registry for adult patients (pts) with RCC who had data about age, race, pathology, surgery and survival outcome. Results: In all 84480 cases of pts: 31605 (37%) females (F) and 52875 (63%) males (M) were reviewed. There were 8663 (10%) African Americans (AA) and 70942 (84%) Caucasians (C). Of the AA pts, there were 3349(39%) AAF and 5314(61%) AAM. Of the C pts, there were 26412(37%) CF and 44530(63%) CM. Clear cell RCC (CRCC) was seen in 69336 (82%); AA pts with CRCC 6166 (71%) , AAF: 2588(77%) and AAM: 3578(67%). C pts with CRCC: 58936(83%) : CM 36443(82%), and CF-22493 (85%) were reviewed. In AA pts with CRCC PN was done 1282 (21%) and RN 4145 (67%)times. AA men had 818 (23%) PN and 2539 (71%) RN, where as AAF had 464 (16%) PN and 1606 (62%) RN. C pts with CRCC had PN 10402 (18%) and RN 37214 (63%) times. CM had PN 6692 (18%) and RN 23594 (65%) times; CF had PN 3710 (16%) and RN 13620 (61%) times. The median size of tumor in pts undergoing PN was 2-3 cm and independent of race or sex. In pts undergoing PN, the median survival for AAM, AAF, CM and CF was 22m, 18m, 23m and 23m respectively. In pts undergoing RN the median survival for AAM, AAF, CM and CF was 23m, 21m, 24m and 23m respectively. In pts over the age of 80, 8240 cases of CRCC were reviewed, and 3950 (48%) pts had no surgery, of pts having any surgery 376 (8%) and 2859 (68%) pts had PN and RN. Median survival of CRCC over 80 years old having no surgery, PN and RN was 5m, 27m and 29m. Race or sex made no impact on proportion of pts having no surgery. Conclusions: C pts esp. CF are more likely to have CRCC histology. The kind of surgery (PN vs. RN) and outcomes after that are similar across both ethnicities and sexes. Pts over 80 yr old are much less likely to have any surgery and have very poor outcomes, this is avoided if they have PN or RN.

Abstract 4300 Introduction: ATRA is the critical component of treatment of APL, and when used in combination with anthracycline chemotherapy can induce remission in over 90% of patients. At initial presentation, patients are at high risk for bleeding or disseminated intravascular coagulation, which may be exacerbated by immediate chemotherapy. Except in patients with marked leukocytosis, ATRA should precede chemotherapy. ATRA is available as 10 mg capsules and should be ingested orally and not crushed. The capsules cannot, therefore, be used in patients unable to swallow, or administered by NGT. Patients and Methods: We present two APL cases where patients unable to swallow and acutely bleeding, received ATRA via NGT. ATRA capsules were opened, the free powder aspirated into a glass syringe, and the remaining capsule contents suspended in soy bean oil and aspirated into the same syringe (Shaw, 1995). Case 1: A 33-year-old female with juvenile onset diabetes and blindness presented with fever vaginal bleeding and coma with response only to painful stimuli. Her white blood count (WBC) was 0.5 k/MicroL with 27% bands, 20% lymphocytes and 10% promyelocytes; platelets were 18 K and PT/PTT was 14.7/33. Bone marrow (BM) was replaced by cells with granular cytoplasm and bilobed nuclei. PML-RARa was not detected by cytogenetics and fluorescent in situ hybridization (FISH), but was by PCR. Daunorubicin was administered and the ATRA oil suspension was given on 14 successive days. Hematologic recovery had occurred by day 16, PCR was negative for PML-RARa by 20, and following consolidation she remains in complete hematologic and cytogenetic remission after 7 months. MRI revealed white matter changes but after IV-HGG she regained consciousness. Case 2: A 66-year-old man with coronary artery disease presented with fever, rectal bleeding and pulmonary hemorrhage, which required intubation and mechanical ventilation. WBC was 7.9 with 3% bands, 19% lymphocytes and 22% promyelocytes. Platelet count was 13 and PT/PTT was 9.6/23.6. BM confirmed APL, with FISH positive for PML- RARa. He was started on ATRA oil suspension via NG tube and daunorubicin. By day 27 FISH was PML-RARa negative, but he continued to require ventilatory support for 3 weeks and succumbed to pneumonia and septic shock. Conclusion: In two patients unable to swallow and bleeding, ATRA administration as an oil suspension via NGT was safe and effective, inducing cytogenetic remission in both. IV liposomal ATRA is not FDA approved and no other parenteral formulation is available. Disclosures: No relevant conflicts of interest to declare.

Abstract 5077 Background: The incidence of BM fibrosis in MM is low and uncertain, and its causes are not known. Cytogenetic and fluorescence in situ hybridization (FISH) in some MM patients reveals prognostically significant anomalies. Methods: Records of patients with MM seen at Kings County Hospital from 2004 through 2010 were reviewed, the histological sections of patients reported to have fibrosis we re-examined. The degree of fibrosis was graded according to the World Health Organization system. Results: Records of 113 patients were reviewed, 110 (97%) were African American (AA). Of these, 62 (55%) were female and 51 (45%) male. Their age ranged (median 65) from 38 to 89 years. Cytogenetic data (CGD) was available in 46 patients; and abnormal in 10 (22%) and normal in 36 (78%) of those. All patients with abnormalities of chromosomal number were hyperdiploid. Of 113 patients, 62 (55%) were female, 110 were African American. Ages ranged from 38–89 (median 65) years. Cytogenetic data was available for 46 patients and abnormal in 10 (22%). All patients with abnormal chromosome numbers were hyperdiploid. FISH studies to detect abnormalities in chromosomes 13, 14 and 17 were available in 25 and abnormal in 2 (8%). BM fibrosis had been initially noted in 27 of 113 patients (24%), and confirmed by another hematopathologist; 17 (63%) were women. The ages of the patients with fibrosis ranged from 4–79 years: median age was 67, 67 for the women and 62 for the men. Focal and grades 1, 2 and 3 fibrosis were noted in 2 (7%), 12 (44%), 7 (26%) and 6 (22%) of patients. Grade 3 fibrosis was found in 24% of the women and 20% of the men with fibrosis. CG data was available for 17 fibrosis patients and abnormal (hyperdipliod) in 2 (18%). FISH studies for chromosomes 13, 14 and 17 were normal in the 7 patients studied. CGD for all 8 of the female fibrosis patients studied were normal, and abnormal in 2 of the 9 men (22%). Conclusions: Of our 113 AA myeloma patients 25% had detectable BM fibrosis, but it was grade 3 in only 5%. Female preponderance was more marked in the patients with fibrosis than in the whole MM group. CG and FISH data did not distinguish patients with and without fibrosis. Disclosures: No relevant conflicts of interest to declare.

e18568 Background: Genomic aberrations are associated with MM survival and disease evolution. The combination of cytogenetics and Fluorescence in situ hybridization (FISH) reveals more anomalies th...

Abstract 4656 A 91-year-old woman with past medical history of hypertension presented with hematuria. There were no ecchymosis, Petechiae or other obvious active bleeding. Her hemoglobin was 11.4 g/dl on presentation hematuria got worse and her hemoglobin drops to 7.6 g/dl over next 48 hours and she was hemodynamically unstable. She was transferred to the Medical Intensive Care Unit for resuscitation with IV fluids and PRBCs. Coagulation tests revealed a prolongation of activated partial thromboplastin time of more than 100 seconds (control 33 seconds) which could not be corrected with mixing normal plasma. Diagnosis of acquired factor VIII inhibitor was considered and recombinant activated factor VII (rFVIIa) was initiated. The factor VIII activity level was reduced to less than 1%. Bethesda assay demonstrated the presence of a factor VIII inhibitor at 103.8 Bethesda units per ml (BU/ml), other coagulation studies were with in normal range. CT scan of her abdomen showed retroperitoneal hematoma. rFVIIa was started at 50 units/kg body weight every 3 hours and subsequently increased to 200 units/kg. She was simultaneously started on steroids. Her hematuria did not improve in spite of high dose rFVIIa. On day 4 rFVIIa was tapered and switched to 50 units/kg FEIBA (Factor eight inhibitor bypass agent). She also received Rituximab 375 mg/m2. We continued FEIBA until day 7 but her hematuria did not improve, she required more than 10 units of Packed Red Blood Cells PRBCs during this period. On day 7 we decided to start plasmapheresis as there were some case reports of using plasmapheresis with or without immunoadsorption columns (which are currently not available in US). We started plasmapheresis and gave her 2 doses of IVIG (Immunoglobulin). Her pre and post plasmapheresis inhibitor levels were 104 BU/ml and 54 BU/ml respectively. Her urine turned pink and her Prbc demand decreased. A second plasmapheresis was done 2 days later showed significant decrease of inhibitor level from 80 BU/ml to 14.5 BU/ml. Her hematuria resolved by next day. We continued her on FEIBA for three more days she did not have hematuria and she did not require any PRBCs. CT scan of abdomen showed decrease in size of retroperitoneal hematoma. Cyclophosphamide 1000 mg was given for induction of immune tolerance followed by high dose factor VIII (100 IU/KG) as per Bonn protocol. Her factor VIII levels and factor VIII inhibitor levels were checked every day before and after Factor VIII infusion. Her inhibitor level is ranging between 14–16 BU/ml she is not bleeding any more and her abdominal hematoma is resolved. Her pre and post transfusion factor VIII levels ranges between 30–40% and 120–140%. respectively. Patient is still getting factor VIII everyday. Role of plasmapheresis is not very well defined in acquired Factor VIII inhibitor patients. Acquired hemophilia is a rare autoimmune disorder in which the patient develop an autoantibody directed against coagulation factor VIII leading to a clinically bleeding diathesis. There are few case reports in literature showing efficacy of Plasmapheresis in this disorder. This is a rare condition and it is very difficult to find large randomized trial to establish a standard of care. Patient mentioned above did not respond to rFVIIa or FEIBA. In our observation plasmapheresis with IVIG proved to be an effective method of rapidly reducing the inhibitor level. In case of life threatening bleeding we need to reduce the inhibitor level quickly. We also observed that once inhibitor level was low bleeding stopped. Immune induction therapy with cyclophosphamide followed by high dose factor VIII was successful in maintaining low inhibitor level. Disclosures: Kessler: Grifols S.A.: Research Funding.

Abstract 5153 Introduction: Iron deficiency suppresses hemoglobin synthesis and erythropoiesis, but the resulting anemia is frequently associated with thrombocytosis. Methods: The clinical and hematologic data of seven women with severe iron deficiency anemia (IDA) and thrombocytopenia were retrospectively analyzed. Results: All patients were African-American women with symptomatic IDA, due to bleeding from uterine fibroids in 6 and from colonic diverticulosis in 1. They were 31–70 years of age, median 38. None had palpable splenomegaly. Hemoglobin ranged from 2.9–5.5, median 4.2 g/dL. MCV ranged from 57–70 fl, median 68. Absolute reticulocyte counts ranged from 19,000 – 23, 000/mm3. The initial serum ferritin ranged from 2 to 42 ng/ml, median 4. Serum iron levels ranged from 10 to 70 mcg/dl with median 30, while iron-binding capacities ranged from 381–426 mcg/dl. Serum erythropoietin (EPO) levels were >2000U/ml in two of the patients. Serum lactic dehydrogenase, bilirubin levels and liver function tests were normal; and Coombs' test negative in all cases. White blood cell counts were normal. The platelet counts ranged from 12 to 103, with a median of 46 × 109/L. Peripheral blood smears showed microcytic hypochromic red blood cells (RBC), with no evidence of platelet clumping. Bone marrow aspiration and biopsy on two patients showed increased numbers of normal megakaryocytes, erythroid hyperplasia and absent iron stores. Six patients were treated with packed RBC transfusions, and ferrous sulphate 325 mg orally was initiated at presentation in 7. Their thrombocytopenia was not treated with steroids or other agents. Three patients' platelet count reached normal or super-normal levels within 72 hours. Six patients were seen at ≥3 months after presentation, and all had achieved normal platelet counts and hemoglobin. Conclusions: These data imply that severe IDA can sometimes cause thrombocytopenia rather than thromobocytosis. We cannot be sure whether these patients' uniform normalization of platelet counts was due to treatment of their anemia by transfusion, or iron therapy. Though bone marrow megakaryocyte numbers were increased in 2 patients, there is no evidence for peripheral platelet destruction. Platelet release from megakaryocytes may have decreased in these patients. Pharmacologic EPO therapy can occasionally cause thrombocytopenia, and high endogenous EPO levels in our patients may have reduce their platelet counts. This conclusion is consistent with their apparent response to transfusion. Though the pathogenesis of IDA-associated thrombocytopenia is not known, our data suggest that the results of anemia and iron deficiency treatment should be evaluated before investigating thrombocytopenia as an independent problem. Disclosures: No relevant conflicts of interest to declare.

Radiation proctitis is a known complication that occurs in about 20% of patients treated with herapy for pelvic malignancies. herapy is often ineffective, and eatment carries a high morbidity and isk because of poor post operative previously irradiated tissue. s with Laser coagulation and formalin redictable and both carry the risk of complications such as strictures. sma coagulation (APC), has been e effective in radiation-induced owever, recurrence rates of bleeding cessitating repeat procedures. This is ecause all angioectatic areas cannot in one session. oretical basis for use of Alum: aluminum ammonium sulfate or potassium sulfate) has been safely urological practice for treatment of rom the bladder in radiation induced ic cystitis. died alum irrigation of the rectum APC treatment of radiation proctitis in zed controlled double blinded trial in mpare the rate of re-bleeding in alum sus saline treated (placebo) patients.