Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | RA |
Acquired hemophilia A/ Factor VIII inhibitor panel showed positive inhibitor; This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired hemophilia A/ Factor VIII inhibitor panel showed positive inhibitor) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: The patient's past medical history included COVID-19 (had mild COVID-19 infection 3 months ago) in 2022 and Sciatica. Concurrent medical conditions included Obesity. In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, after starting mRNA-1273 (Spikevax), the patient experienced ACQUIRED HAEMOPHILIA (Acquired hemophilia A/ Factor VIII inhibitor panel showed positive inhibitor) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in 2022 to sometime in 2022 due to ACQUIRED HAEMOPHILIA. The patient was treated with Prednisone from 2022 to 2022 at a dose of on day 2; Prednisone in 2022 at a dose of 120 milligram four times per day; Kcentra from 2022 to 2022 at a dose of 1 dose of four factor prothrombin concentrate on day 3; Ciclosporin (Cyclosporine) from 2022 to 2022 at a dose of 250 milligram twice a day; Ciclosporin (Cyclosporine) from 2022 to 2022 at a dose of 250 milligram twice a day and Cyclophosphamide in 2022 at a dose of 150 milligram once a day. In 2022, ACQUIRED HAEMOPHILIA (Acquired hemophilia A/ Factor VIII inhibitor panel showed positive inhibitor) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, Activated partial thromboplastin time (25.1-36.5 Second): 60 Second on first follow-up. On 07-Apr-2022, Anti factor VIII antibody test: (Positive) on first follow-up. On 07-Apr-2022, Coagulation factor VIII level (50-150): on first follow-up: result: less than 5 % (high). On 07-Apr-2022, Eosinophil percentage: 0.1 % on first follow up. On 07-Apr-2022, Factor VIII activity test (50-180): on first follow-up: result: less than 1, on first follow-up: result: 0.5 and on first follow-up: result: 25.7 BU. On 07-Apr-2022, Granulocyte percentage (Unknown-1 %): 1 % on first follow-up. On 07-Apr-2022, Haemoglobin (13-16 g/dL): 12.5 g/dL on first follow up. On 07-Apr-2022, Immature granulocyte count (Unknown-1): on first follow-up: 0.15. On 07-Apr-2022, International normalised ratio (Unknown-1.1): on first follow-up:0.89. On 07-Apr-2022, Lymphocyte percentage (20-40 %): 10.2 % on first follow-up. On 07-Apr-2022, Mean cell volume (78-98 fL): 100.3 fL on first follow up. On 07-Apr-2022, Monocyte percentage: 11.8 % on first follow up. On 07-Apr-2022, Neutrophil percentage (40-60 %): 76.8 % on first follow-up. On 07-Apr-2022, Physical examination: stable hematoma size and was discharged same medications on day 20. On 07-Apr-2022, Platelet count (150-400 thousand per microlitre): 217 thousand per microlitre on first follow up. On 07-Apr-2022, Prothrombin time (9.4-12.5 Second): 10.1 Second on first follow up. On 07-Apr-2022, Red blood cell count (3.5-5.5 million per cubic millimetre): 3.87 million per cubic millimetre on first follow up. On 07-Apr-2022, Red cell distribution width (39-46 fL): 54.7 fL on second follow up. On 07-Apr-2022, White blood cell count (4.5-11 thousand per microlitre): 15.55 thousand per microlitre on first follow up. On 19-Apr-2022, Activated partial thromboplastin time (25.1-36.5 Second): 39.5 Second on second follow-up. On 19-Apr-2022, Coagulation factor VIII level (50-150 %): 42 % on second follow-up. On 19-Apr-2022, Eosinophil percentage: 0.3 % on second follow up. On 19-Apr-2022, Granulocyte percentage (Unknown-1 %): 1.1 % on second follow-up. On 19-Apr-2022, Haemoglobin (13-16 g/dL): 13 g/dL on second follow up. On 19-Apr-2022, Immature granulocyte count (Unknown-1): on second follow-up: 0.12. On 19-Apr-2022, International normalised ratio (Unknown-1.1): on second follow-up:0.89. On 19-Apr-2022, Lymphocyte percentage (20-40 %): 9.5 % on second follow-up. On 19-Apr-2022, Mean cell volume (78-98 fL): 97.7 fL on second follow up. On 19-Apr-2022, Monocyte percentage: 8.3 % on second follow up. On 19-Apr-2022, Neutrophil percentage (40-60 %): 80.6 % on second follow-up. On 19-Apr-2022, Platelet count (150-400 thousand per microlitre): 201 thousand per microlitre on second follow up. On 19-Apr-2022, Prothrombin time (9.4-12.5 Second): 10.2 Second on second follow up. On 19-Apr-2022, Red blood cell count (3.5-5.5 million per cubic millimetre): 3.97 million per cubic millimetre on second follow up. On 19-Apr-2022, Red cell distribution width (39-46 fL): 51.7 fL on second follow up. On 19-Apr-2022, White blood cell count (4.5-11 thousand per microlitre): 10.6 thousand per microlitre on second follow up. In 2022, Activated partial thromboplastin time (25.1-36.5 Second): 92.8 Second on admission: elevated, 87.8 Second on day 10 and 89.1 Second on second admission, on day 14. In 2022, Anti factor VIII antibody test: Positive and (Positive) on second admission: Factor VIII Inhibitor Screen with 41.1 Bethesda units (BU). In 2022, Antibody test: Negative. In 2022, Antinuclear antibody: Negative. In 2022, Bilirubin conjugated (0-0.2 milligram per decilitre): 0.5 milligram per decilitre on admission. In 2022, Blood bilirubin (0-1 milligram per decilitre): 2.1 milligram per decilitre on admission, elevated. In 2022, Blood fibrinogen (200-400 milligram per decilitre): 168 milligram per decilitre on admission. In 2022, Blood iron (37-145 microgram per decilitre): 79 microgram per decilitre on admission. In 2022, Blood lactate dehydrogenase (135-225 U/L): 280 U/L on admission: elevated. In 2022, Blood smear test: on admission. showed macrocytic anemia, leukoerythroblastosis and neutrophilic leukocytosis. In 2022, Blood thromboplastin (25-35 Second): 33.6 Second on admission. In 2022, C-reactive protein (0-0.5): on admission: less than 0.3. In 2022, Coagulation factor IX level (50-150): on admission, result: 135 units/dl. In 2022, Coagulation factor VII level (50-200 %): 75 % on admission (high). In 2022, Coagulation factor VIII level (50-150): on admission, result: less than 5 %. In 2022, Coagulation factor XI level (60-70): on admission: result: 66 units/dl. In 2022, Coagulation factor XII level (50-200 %): 42 % on admission (high). In 2022, Computerised tomogram thorax: normal except a 3 mm pulmonary nodule. In 2022, Eosinophil percentage: 0 % on admission and 0 % on second admission. In 2022, Factor VIII activity test (50-180): on admission: result: less than 1, on second admission: result: less than 1, on admission: Nijmegen assay: result: 52.8 and on second admission: Nijmegen assay: result: 41.1. In 2022, Fibrin D dimer (Unknown-500): on admission: 6277. In 2022, Granulocyte percentage (Unknown-1 %): 1.1 % on second admission. In 2022, Haemoglobin (13-16 g/dL): 9.2 g/dL on admission, 11.5 g/dL on second admission and 7.2 g/dL Labs on admission showed macrocytic hyper-proliferative anemia. In 2022, Haptoglobin (43-212): on admission: 149: normal. In 2022, Immature granulocyte count (Unknown-1): on second admission: 0.14. In 2022, International normalised ratio (Unknown-1.1): on admission: Result: 0.96 and on second admission: Result: 0.98. In 2022, Iron binding capacity total (250-450 microgram per decilitre): 193 microgram per decilitre on admission: low. In 2022, Lymphocyte percentage (20-40 %): 8.6 % on admission and 2.1 % on second admission. In 2022, Mean cell volume (78-98 fL): 97.9 fL on admission and 100.6 fL on second admission. In 2022, Metabolic function test: Normal. In 2022, Monocyte percentage: 9.9 % on admission and 2.9 % on second admission. In 2022, Neutrophil percentage (40-60 %): 80 % on admission and 93.7 % on second admission. In 2022, Physical examination: subsequent follow ups patient did well and left arm hematoma had completely disappeared, and the right arm bruise was 3 x 3 cm. and hematoma improved on day 10. In 2022, Platelet count (150-400 thousand per microlitre): 267 thousand per microlitre on admission and 242 thousand per microlitre on second admission. In 2022, Prothrombin time (9.4-12.5 Second): 11 Second on admission and 11.2 Second on second admission. In 2022, Red blood cell count (3.5-5.5 million per cubic millimetre): 2.91 million per cubic millimetre on admission and 3.52 million per cubic millimetre on second admission. In 2022, Red blood cell sedimentation rate (Unknown-20 mm/hr): 1 mm/hr on admission. In 2022, Red cell distribution width (39-46 fL): 55.6 fL on admission and 60 fL on second admission. In 2022, Serum ferritin (13-150 ng/mL): 226 ng/mL on admission: high. In 2022, Thrombin time (14-19 Second): 15.8 Second on admission. In 2022, Ultrasound abdomen: Normal. In 2022, Vital signs measurement: Normal. In 2022, Vitamin B12 (232-1245 picogram per millilitre): 171 picogram per millilitre on admission: low. In 2022, Von Willebrand's factor activity test (60-180 %): 248 % Ristocetin Cofactor and 273 on admission: high. In 2022, Von Willebrand's factor antigen test (42-176): 248. In 2022, White blood cell count (4.5-11 thousand per microlitre): 14.69 thousand per microlitre on admission and 13.32 thousand per microlitre on second admission. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The patient presented to the hospital on with worsening swelling and ecchymosis of her left arm. She received her second dose of the Moderna vaccine on the right arm 3 days ago. Following her vaccination three days later she noticed a bruise in her right arm which progressed to involve her left upper extremity. The patient had no allergies, no history of immune deficiency, no recent infections or fevers, and no personal or family history of any bleeding disorders. Upon admission lab tests were performed. Mixing study initially corrected to 43.5 seconds at 0 seconds but prolonged to 85 seconds at 60 seconds indicating a possible inhibitor. Factor VIII inhibitor panel showed positive inhibitor which was 52.8 on admission. After this work up, a case acquired hemophilia A (AHA) was diagnosed. Upon initiation of treatment, patient's hematoma improved and PTT was 87.8 on day 10 and was discharged on steroid taper. The patient was readmitted on day 14. Cyclosporine and prednisone were continued. Cyclosporine trough was within the expected therapeutic range. The patient continued to have stable hematoma size and was discharged same medications on day 20 with close follow up appointment on day 23. On follow-up her hematoma was stable in the clinic and coagulation panel showed improving PTT from 80 to 60 seconds and inhibitor level was 25.7 Bethesda units (BU). Factor VIII inhibitors were still present, and factor 8 levels were undetectable. Cyclosporine was stopped and the patient was given cyclophosphamide. Patient was started on daily prophylaxis for Pneumocystis jirovecii. On follow-up on day 36, PTT was trending down, and factor VIII level increased to 42. On subsequent follow ups patient did well and left arm hematoma has completely disappeared, and the right arm bruise was 3 x 3 cm. This case presented AHA following the second dose of Moderna vaccine in patient with a history of mild COVID-19 infection and it's role in the immunological process of this phenomenon remained unknown. The patient had COVID-19 infection in the past and it has been reported that failure of regulatory T-cell activation by the infection might play a crucial role in FVIII inhibitor synthesis The patient had high PTT and low Factor VII level which improved after cyclophosphamide treatment on day 36. Immunosuppressive agents may work by either direct cytotoxicity to the hematopoietic cells in case of cyclophosphamide or by inhibition of calcineurin-dependent gene transcription caused by cyclosporine. Recent studies had shown that combination treatment with steroids had a better complete response rate than monotherapy but was associated with higher infection rate. Author concluded that this case report was not conclusive that COVID-19 vaccination was the cause of AHA, as we could not completely exclude spontaneous hemophilia from other causes in these patients. The authors and the medical community continued to advocate for universal COVID-19 vaccination in society. Overall, further research and monitoring for adverse events will lead to best treatment practices related to COVID-19 vaccination.; Reporter's Comments: Previous COVID-19 infection is a confounder for the event. The benefit-risk relationship of product is not affected by this report.
Obesity
Medical History/Concurrent Conditions: COVID-19 (had mild COVID-19 infection 3 months ago); Sciatica
Test Date: 20220407; Test Name: PTT; Test Result: 60 s; Test Date: 20220419; Test Name: PTT; Test Result: 39.5 s; Test Date: 2022; Test Name: PTT; Test Result: 92.8 s; Test Date: 2022; Test Name: PTT; Test Result: 87.8 s; Test Date: 2022; Test Name: PTT; Test Result: 89.1 s; Test Date: 20220407; Test Name: Factor VIII Inhibitor Screen; Test Result: Positive ; Test Date: 2022; Test Name: Factor VIII Inhibitor Screen; Test Result: Positive ; Test Date: 2022; Test Name: Factor VIII Inhibitor Screen; Test Result: Positive ; Test Date: 2022; Test Name: Extensive antibody screen; Test Result: Negative ; Test Date: 2022; Test Name: Antinuclear antibody; Test Result: Negative ; Test Date: 2022; Test Name: Direct bilirubin; Test Result: 0.5 mg/dL; Test Date: 2022; Test Name: Total bilirubin; Test Result: 2.1 mg/dL; Test Date: 2022; Test Name: Fibrinogen level; Test Result: 168 mg/dL; Test Date: 2022; Test Name: Iron; Result Unstructured Data: Test Result:79 ug/dL;on admission; Test Date: 2022; Test Name: LDH; Result Unstructured Data: Test Result:280 U/L;on admission: elevated; Test Date: 2022; Test Name: Peripheral blood smear; Result Unstructured Data: on admission. showed macrocytic anemia, leukoerythroblastosis and neutrophilic leukocytosis; Test Date: 2022; Test Name: Normal plasma PTT; Test Result: 33.6 s; Test Date: 2022; Test Name: Factor IX level; Result Unstructured Data: on admission, result: 135 units/dl; Test Date: 2022; Test Name: Factor VII level; Test Result: 75 %; Test Date: 20220407; Test Name: Factor VIII level; Result Unstructured Data: on first follow-up: result: less than 5 % (high); Test Date: 2022; Test Name: Factor VIII level; Result Unstructured Data: on admission, result: less than 5 %; Test Date: 20220419; Test Name: Factor VIII level; Test Result: 42 %; Test Date: 2022; Test Name: Factor XI level; Result Unstructured Data: on admission: result: 66 units/dl; Test Date: 2022; Test Name: Factor XII level; Test Result: 42 %; Test Date: 2022; Test Name: CT Scan of Chest; Result Unstructured Data: normal except a 3 mm pulmonary nodule; Test Date: 2022; Test Name: CRP; Result Unstructured Data: on admission: less than 0.3; Test Date: 20220407; Test Name: Automated Eosinophils; Test Result: 0.1 %; Test Date: 20220419; Test Name: Automated Eosinophils; Test Result: 0.3 %; Test Date: 2022; Test Name: Automated Eosinophils; Test Result: 0 %; Test Date: 2022; Test Name: Automated Eosinophils; Test Result: 0 %; Test Date: 20220407; Test Name: Factor VIII activity; Result Unstructured Data: on first follow-up: result: less than 1; Test Date: 2022; Test Name: Factor VIII activity; Result Unstructured Data: on admission: result: less than 1; Test Date: 2022; Test Name: Factor VIII activity; Result Unstructured Data: on second admission: result: less than 1; Test Date: 20220407; Test Name: Factor VIII AG; Result Unstructured Data: on first follow-up: result: 0.5; Test Date: 20220407; Test Name: Nijmegen assay; Result Unstructured Data: on first follow-up: result: 25.7 BU; Test Date: 2022; Test Name: Nijmegen assay; Result Unstructured Data: on admission: Nijmegen assay: result: 52.8; Test Date: 2022; Test Name: Nijmegen assay; Result Unstructured Data: on second admission: Nijmegen assay: result: 41.1; Test Date: 2022; Test Name: D Dimer; Result Unstructured Data: on admission: 6277; Test Date: 20220407; Test Name: Automated immature granulocytes; Test Result: 1 %; Test Date: 20220419; Test Name: Automated immature granulocytes; Test Result: 1.1 %; Test Date: 2022; Test Name: Automated immature granulocytes; Test Result: 1.1 %; Test Date: 20220407; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.5 g/dL;on first follow up; Test Date: 20220419; Test Name: hemoglobin; Result Unstructured Data: Test Result:13 g/dL;on second follow up; Test Date: 2022; Test Name: hemoglobin; Result Unstructured Data: Test Result:9.2 g/dL;on admission; Test Date: 2022; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5 g/dL;on second admission; Test Date: 2022; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.2 g/dL;Labs on admission showed macrocytic hyper-proliferative anemia; Test Date: 2022; Test Name: Haptoglobin; Result Unstructured Data: on admission: 149: normal; Test Date: 20220407; Test Name: Automated absolute IGAB; Result Unstructured Data: on first follow-up: 0.15; Test Date: 20220419; Test Name: Automated absolute IGAB; Result Unstructured Data: on second follow-up: 0.12; Test Date: 2022; Test Name: Automated absolute IGAB; Result Unstructured Data: on second admission: 0.14; Test Date: 20220407; Test Name: INR; Result Unstructured Data: on first follow-up:0.89; Test Date: 20220419; Test Name: INR; Result Unstructured Data: on second follow-up:0.89; Test Date: 2022; Test Name: INR; Result Unstructured Data: on admission: Result: 0.96; Test Date: 2022; Test Name: INR; Result Unstructured Data: on second admission: Result: 0.98; Test Date: 2022; Test Name: Total iron binding capacity; Result Unstructured Data: Test Result:193 ug/dL;on admission: low; Test Date: 20220407; Test Name: Automated lymphocytes; Test Result: 10.2 %; Test Date: 20220419; Test Name: Automated lymphocytes; Test Result: 9.5 %; Test Date: 2022; Test Name: Automated lymphocytes; Test Result: 8.6 %; Test Date: 2022; Test Name: Automated lymphocytes; Test Result: 2.1 %; Test Date: 20220407; Test Name: MCV; Result Unstructured Data: Test Result:100.3 fL;on first follow up; Test Date: 20220419; Test Name: MCV; Result Unstructured Data: Test Result:97.7 fL;on second follow up; Test Date: 2022; Test Name: MCV; Result Unstructured Data: Test Result:97.9 fL;on admission; Test Date: 2022; Test Name: MCV; Result Unstructured Data: Test Result:100.6 fL;on second admission; Test Date: 2022; Test Name: Comprehensive metabolic panel; Result Unstructured Data: Normal; Test Date: 20220407; Test Name: Automated monocytes; Test Result: 11.8 %; Test Date: 20220419; Test Name: Automated monocytes; Test Result: 8.3 %; Test Date: 2022; Test Name: Automated monocytes; Test Result: 9.9 %; Test Date: 2022; Test Name: Automated monocytes; Test Result: 2.9 %; Test Date: 20220407; Test Name: Automated segmented neutrophils; Test Result: 76.8 %; Test Date: 20220419; Test Name: Automated segmented neutrophils; Test Result: 80.6 %; Test Date: 2022; Test Name: Automated segmented neutrophils; Test Result: 80 %; Test Date: 2022; Test Name: Automated segmented neutrophils; Test Result: 93.7 %; Test Date: 20220407; Test Name: Physical examination; Result Unstructured Data: stable hematoma size and was discharged same medications on day 20; Test Date: 2022; Test Name: Physical examination; Result Unstructured Data: subsequent follow ups patient did well and left arm hematoma had completely disappeared, and the right arm bruise was 3 x 3 cm.; Test Date: 2022; Test Name: Physical examination; Result Unstructured Data: hematoma improved on day 10; Test Date: 20220407; Test Name: Platelet; Result Unstructured Data: Test Result:217 10*3/uL;on first follow up; Test Date: 20220419; Test Name: Platelet; Result Unstructured Data: Test Result:201 10*3/uL;on second follow up; Test Date: 2022; Test Name: Platelet; Result Unstructured Data: Test Result:267 10*3/uL;on admission; Test Date: 2022; Test Name: Platelet; Result Unstructured Data: Test Result:242 10*3/uL;on second admission; Test Date: 20220407; Test Name: PT; Test Result: 10.1 s; Test Date: 20220419; Test Name: PT; Test Result: 10.2 s; Test Date: 2022; Test Name: PT; Test Result: 11 s; Test Date: 2022; Test Name: PT; Test Result: 11.2 s; Test Date: 20220407; Test Name: RBC; Result Unstructured Data: Test Result:3.87 10*6/mm3;on first follow up; Test Date: 20220419; Test Name: RBC; Result Unstructured Data: Test Result:3.97 10*6/mm3;on second follow up; Test Date: 2022; Test Name: RBC; Result Unstructured Data: Test Result:2.91 10*6/mm3;on admission; Test Date: 2022; Test Name: RBC; Result Unstructured Data: Test Result:3.52 10*6/mm3;on second admission; Test Date: 2022; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:1 mm/h;on admission; Test Date: 20220407; Test Name: RDW-SD; Result Unstructured Data: Test Result:54.7 fL;on second follow up; Test Date: 20220419; Test Name: RDW-SD; Result Unstructured Data: Test Result:51.7 fL;on second follow up; Test Date: 2022; Test Name: RDW-SD; Result Unstructured Data: Test Result:55.6 fL;on admission; Test Date: 2022; Test Name: RDW-SD; Result Unstructured Data: Test Result:60 fL;on second admission; Test Date: 2022; Test Name: Ferritin; Result Unstructured Data: Test Result:226 ng/mL;on admission: high; Test Date: 2022; Test Name: Thrombin time; Test Result: 15.8 s; Test Date: 2022; Test Name: Ultrasound of abdomen; Result Unstructured Data: Normal; Test Date: 2022; Test Name: Vitals; Result Unstructured Data: Normal; Test Date: 2022; Test Name: Vitamin B12; Result Unstructured Data: Test Result:171 pg/mL;on admission: low; Test Date: 2022; Test Name: Ristocetin Cofactor; Test Result: 248 %; Test Date: 2022; Test Name: Vwf activity; Result Unstructured Data: 273 on admission: high; Test Date: 2022; Test Name: Vwf AG; Result Unstructured Data: 248; Test Date: 20220407; Test Name: WBC; Result Unstructured Data: Test Result:15.55 10*3/uL;on first follow up; Test Date: 20220419; Test Name: WBC; Result Unstructured Data: Test Result:10.6 10*3/uL;on second follow up; Test Date: 2022; Test Name: WBC; Result Unstructured Data: Test Result:14.69 10*3/uL;on admission; Test Date: 2022; Test Name: WBC; Result Unstructured Data: Test Result:13.32 10*3/uL;on second admission