Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | — | — |
diagnosed with acquired hemophilia A; This spontaneous case was reported by a non-health professional and describes the occurrence of ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) (seriousness criterion medically significant). The patient was treated with Cyclophosphamide at an unspecified dose and frequency. At the time of the report, ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor VIII activity test: improved and 1 % crucial protein involved in forming blood clots to stop bleeding, levels were only at one percent in his body. On an unknown date, Laboratory test: Tests revealed he was suffering from hemophilia A. On an unknown date, Liver function test: Appeared Normal. On an unknown date, Platelet count: Appeared Normal and Normal. On an unknown date, Renal function test: Appeared Normal. On an unknown date, White blood cell count: Appeared Normal and Normal. It was reported that patient went to hospital after he saw blood in his stool. Patient thought it was due to the colonoscopy (results not provided) that he had the day before. During examination doctor noticed large, dark bruises on both of patient arms that had developed within the span of a few days. Initially patient went to the doctors, and his white blood cell count, platelets count, liver and kidney function all appeared normal during tests. However, patient continued bruising on his arms and which worsen. Patient developed large marks on his left knee two weeks later. Hence doctor ordered more intensive blood tests which included a plasma test. Results showed that while his white cell and platelets counts were normal, they were certain antibodies present in his plasma that were not allowing the body's clotting process to function. Further test showed that his body's FVIII, crucial protein involved in forming blood clots to stop bleeding, levels were only at one percent in his body. As a result, he was diagnosed with acquired hemophilia A - which was known to primarily target the FVIII protein in the body. Patients also develop also complications associated with abnormal, uncontrolled bleeding into the muscles, skin, and soft tissue that could occur spontaneously, during surgery or following trauma. Tests revealed that patient suffered from hemophilia A, where the body prevents blood from clotting, and it caused excessive bleeding from wounds for days at end. It was reported that this prolonged bleeding could cause blood to accumulate beneath the skin and which formed a bruise. Additionally, it was also reported that bruise can caused more susceptible to injuries. Patient had sustained wounds from a colorectal procedure, they were mostly bleeding internally, and the blood was only visible in the stool. The patient had no family history of the condition and was not actively bleeding, according to a medical report about his case. However, it was reported that patient symptom onset was a week after patient had received his Moderna Covid vaccine booster as his fifth dose. The experts theorized that it was possible the shot triggered his immune system to produce antibodies against his body's clotting process and caused the disorder. For treatment, patient was asked to visit a hematology clinic every week and patient started to take cyclophosphamide. The doctors progressively decreased his treatment medication cyclophosphamide dosage regimen as his FVIII levels improved and he showed signs of recovery. Along with this, patient was also given with unspecified treatment medications to prevent fungal infections and protect the stomach. This case was linked to US-MODERNATX, INC.-MOD-2025-786649, US-MODERNATX, INC.-MOD-2025-786855, US-MODERNATX, INC.-MOD-2025-786865, US-MODERNATX, INC.-MOD-2025-786854, US-MODERNATX, INC.-MOD-2025-786866, US-MODERNATX, INC.-MOD-2025-786867, US-MODERNATX, INC.-MOD-2025-786853, US-MODERNATX, INC.-MOD-2025-786851, US-MODERNATX, INC.-MOD-2025-786868, US-MODERNATX, INC.-MOD-2025-786869, US-MODERNATX, INC.-MOD-2025-786856, US-MODERNATX, INC.-MOD-2025-786859, US-MODERNATX, INC.-MOD-2025-786861, US-MODERNATX, INC.-MOD-2025-786862, US-MODERNATX, INC.-MOD-2025-786870, US-MODERNATX, INC.-MOD-2025-786860, US-MODERNATX, INC.-MOD-2025-786858, US-MODERNATX, INC.-MOD-2025-786857, US-MODERNATX, INC.-MOD-2025-786852, US-MODERNATX, INC.-MOD-2025-786871, US-MODERNATX, INC.-MOD-2025-786872 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786649:Same reporter different patient US-MODERNATX, INC.-MOD-2025-786859:Patient 20 of 22 US-MODERNATX, INC.-MOD-2025-786861:Patient 21 of 22 US-MODERNATX, INC.-MOD-2025-786856:Patient 19 of 22 US-MODERNATX, INC.-MOD-2025-786853:Patient 15 US-MODERNATX, INC.-MOD-2025-786851:Patient 14 US-MODERNATX, INC.-MOD-2025-786867:Patient 12 of 21 US-MODERNATX, INC.-MOD-2025-786855:Patient 17 US-MODERNATX, INC.-MOD-2025-786854:Patient 16 US-MODERNATX, INC.-MOD-2025-786869:Patient 6 of 21 US-MODERNATX, INC.-MOD-2025-786865:Patient 10 of 21 US-MODERNATX, INC.-MOD-2025-786866:Patient 11 of 21 US-MODERNATX, INC.-MOD-2025-786868:Patient 13 of 21 US-MODERNATX, INC.-MOD-2025-786862:Patient 22 of 22 US-MODERNATX, INC.-MOD-2025-786870:Patient 7 of 21 US-MODERNATX, INC.-MOD-2025-786858:Patient 4 of 22 US-MODERNATX, INC.-MOD-2025-786852:Patient 2 of 22 US-MODERNATX, INC.-MOD-2025-786860:Patient 5 of 22 US-MODERNATX, INC.-MOD-2025-786871:Patient 8 of 21 US-MODERNATX, INC.-MOD-2025-786857:Patient 3 of 22 US-MODERNATX, INC.-MOD-2025-786872:Patient 9 of 21
Test Name: FVIII; Result Unstructured Data: improved; Test Name: FVIII; Test Result: 1 %; Test Name: tests; Result Unstructured Data: Tests revealed he was suffering from hemophilia A; Test Name: Liver function test; Result Unstructured Data: Appeared Normal; Test Name: platelet count; Result Unstructured Data: Appeared Normal; Test Name: platelet count; Result Unstructured Data: Normal; Test Name: Kidney function test; Result Unstructured Data: Appeared Normal; Test Name: White blood cell count/white cell; Result Unstructured Data: Appeared Normal; Test Name: White blood cell count/white cell; Result Unstructured Data: Normal