Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | — | — |
Acquired haemophilia A; multifocal pneumonia; Normocytic anaemia; This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired haemophilia A) and PNEUMONIA (multifocal pneumonia) in an 8-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Adenocarcinoma of prostate (high-risk, (treated with prostatectomy, adjuvant radiotherapy and androgen deprivation therapy 4 years ago, now under surveillance with a normal PSA of less than 0.1ng/mL), Coronary artery bypass graft, Renal artery stent placement, Prostatectomy (high-risk prostate adenocarcinoma), Radiotherapy to prostate (high-risk prostate adenocarcinoma), Colonoscopy (removal of 3 subcentimetre tubular adenomas) and Root canal procedure. Previously administered products included for Drug use for unknown indication: lidocaine since an unknown date. Past adverse reactions to the above products included No adverse effect with lidocaine. Concurrent medical conditions included Coronary artery disease, Hyperlipidaemia, Hypertension, Renal artery stenosis and Unintentional weight loss (Unintentional 20-pound weight loss over 4 months). On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (Acquired haemophilia A) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced PNEUMONIA (multifocal pneumonia) (seriousness criterion medically significant) and NORMOCYTIC ANAEMIA (Normocytic anaemia). The patient was treated with Prednisone (oral use) for Acquired haemophilia, at a dose of 1 milligram/kilogram once a day; Prednisone (oral use) for Acquired haemophilia, at a dose of 5 milligram, every 4 days; Cyclophosphamide for Acquired haemophilia, at a dose of 100 milligram once a day; Cyclophosphamide for Acquired haemophilia, at a dose of 25 milligram every two weeks and Azithromycin for Pneumonia, at an unspecified dose and frequency. At the time of the report, ACQUIRED HAEMOPHILIA (Acquired haemophilia A) and PNEUMONIA (multifocal pneumonia) had resolved and NORMOCYTIC ANAEMIA (Normocytic anaemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time: normalised on day 14 after starting cyclophosphamide, 55 secs, 62 secs Prolonged, 44.8 secs the aPTT was 62.3 and fully corrected on immediate mix to 34.4, then prolonged to 44.8s on incubation. This pattern suggests the presence of an inhibitor. and 35 secs About 10 days after starting prednisone. On an unknown date, Anti-cyclic citrullinated peptide antibody: 3 units. On an unknown date, Antineutrophil cytoplasmic antibody: less than 0.2U/mL, less than 0.2 units, less than 1:20 and less than 1:20. On an unknown date, Antinuclear antibody: SSA/anti-Ro less than 0.2 and SSB/anti-La less than 0.2. On an unknown date, Antiphospholipid antibodies: Normal. On an unknown date, Blood fibrinogen: 296 mg/dl Normal. On an unknown date, Blood thyroid stimulating hormone (0.4-4.7): less than 0.015 uIU/mL. On an unknown date, C-reactive protein: less than 1mg/dL. On an unknown date, Coagulation factor IX level: Normal. On an unknown date, Coagulation factor XI level: Normal. On an unknown date, Coagulation factor XII level: Normal. On an unknown date, Coagulation test: repeat BA showed eradication of the inhibitor and 4.8 Bethesda unit per millilitre Bethesda assay. On an unknown date, Complement factor C3: 87 mg/dl. On an unknown date, Complement factor C4: 21 mg/dl. On an unknown date, Computerised tomogram abdomen: unremarkable. On an unknown date, Computerised tomogram pelvis: unremarkable. On an unknown date, Factor VIII activity test (57-163 %): 1 %, 2 %, 6 %, 22 % About 10 days after starting prednisone, 60 % Seven days after initiating cyclophosphamide and 125 % day 14 after initiating cyclophosphamide. On an unknown date, Fibrin D dimer: 457 ng/mL Normal. On an unknown date, Haemoglobin: 10.4 gram per litre Normocytic anaemia and baseline was15 g/L 2 years prior, 13.3 gram per litre and 12.2 gram per litre at haematology clinic. On an unknown date, Inflammatory marker test: Normal. On an unknown date, International normalised ratio: normal at 1.14 and Normal at 1. On an unknown date, Laboratory test: A 1:1 mixing assay showed aPTT 62.3 that fully corrected on immediate mix to 34.4, then prolonged to 44.8s on incubation, which suggested the presence of clotting factor inhibitors.. On an unknown date, Liver function test: Normal. On an unknown date, Platelet count: 236 10^9/L Normal and 252 10^9/L. On an unknown date, Prostatic specific antigen: less than 0.1ng/mL and less than 0.04ng/mL. On an unknown date, Prothrombin time (9.1-12 secs): 12.7 secs mildly elevated and 11.3 secs Normal. On an unknown date, Red blood cell sedimentation rate: 2 mm/hr. On an unknown date, Renal function test: Normal. On an unknown date, Thyroid function test: Repeat thyroid studies were normal.. On an unknown date, Thyroxine free (0.82-1.77 ng/dL): 1.16 ng/dL normal. On an unknown date, Tri-iodothyronine (71-180 ng/dL): 66 ng/dL mildly low. On an unknown date, Vital signs measurement: vital signs were normal, and he was well appearing.. On an unknown date, Von Willebrand's factor activity test: 147 % Normal. On an unknown date, Von Willebrand's factor antigen test: 150 % Normal. On an unknown date, Weight: unintentional 20 pound weight loss over 4 months. On an unknown date, White blood cell count: 7.3 10^9/L Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACQUIRED HAEMOPHILIA (Acquired haemophilia A) to be related. No further causality assessments were provided for PNEUMONIA (multifocal pneumonia) and NORMOCYTIC ANAEMIA (Normocytic anaemia). Patient presented to ER with 2days of haematochezia. The bleeding began the night after a colonoscopy and 2days following a root canal procedure. The dental procedure was complicated by local haematoma formation at the lidocaine injection site. Bleeding episodes were preceded 1week prior with receipt of his fifth COVID-19 booster. Patient endorsed fatigue, chest pain and palpitations. He denied any constitutional symptoms, myalgias or arthralgias. He had an unintentional 20-pound weight loss over 4 months and noted bilateral upper extremity bruises within the last few days. The patient was not actively bleeding and so was discharged. Bruising progressed (a large bruise developed over his left cubital fossa). 2weeks later, he developed a large left knee haematoma. Given the stability of the patient and the absence of active bleeding, he started oral prednisone. Bethesda assay (BA) result correlated with a 6% FVIII activity level and a diagnosis of AHA. Received additional immunosuppression, with cyclophosphamide added to a prednisone taper initiated at 1 mg/kg. The plan for the prednisone taper was to decrease by 5 mg every 4 days as long as FVIII activity continued to improve. Once the BA reflected successful eradication of the inhibitor, the cyclophosphamide was decreased by 25 mg every 2 weeks. Appropriate prophylaxis for fungal infections along with proton pump inhibitors was also prescribed and he did not develop significant bleeding to warrant initiation of a bypassing agent. His treatment was complicated by a course of flu-like symptoms, so immunosuppression was held while the prednisone was slowly tapered. He completed a course of Azithromycin for multifocal pneumonia and his symptoms improved along with his blood counts and factor levels. At this time, he has been off treatment for 10 months and remains free of any bleeding symptoms.; Reporter's Comments: Causality for Pneumonia was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Coronary artery disease; Hyperlipidaemia; Hypertension; Renal artery stenosis; Unintentional weight loss (Unintentional 20-pound weight loss over 4 months)
Medical History/Concurrent Conditions: Adenocarcinoma of prostate (high-risk, (treated with prostatectomy, adjuvant radiotherapy and androgen deprivation therapy 4 years ago, now under surveillance with a normal PSA of less than 0.1ng/mL); Colonoscopy (removal of 3 subcentimetre tubular adenomas); Coronary artery bypass graft; Prostatectomy (high-risk prostate adenocarcinoma); Radiotherapy to prostate (high-risk prostate adenocarcinoma); Renal artery stent placement; Root canal procedure
Test Name: aPTT; Result Unstructured Data: normalised on day 14 after starting cyclophosphamide; Test Name: aPTT; Test Result: 55 s; Test Name: aPTT; Test Result: 62 s; Test Name: aPTT; Test Result: 44.8 s; Test Name: aPTT; Test Result: 35 s; Test Name: anti-CCP; Result Unstructured Data: 3 units; Test Name: anti-MPO antibodies; Result Unstructured Data: less than 0.2U/mL; Test Name: anti-PR3-antibodies; Result Unstructured Data: less than 0.2 units; Test Name: c-ANCA; Result Unstructured Data: less than 1:20; Test Name: p-ANCA; Result Unstructured Data: less than 1:20; Test Name: SSA/anti-Ro; Result Unstructured Data: SSA/anti-Ro less than 0.2; Test Name: SSB/anti-La; Result Unstructured Data: SSB/anti-La less than 0.2; Test Name: Antiphospholipid antibody; Result Unstructured Data: Normal; Test Name: fibrinogen; Test Result: 296 mg/dL; Test Name: TSH; Result Unstructured Data: less than 0.015 uIU/mL; Test Name: Factor IX; Result Unstructured Data: Normal; Test Name: Factor XI; Result Unstructured Data: Normal; Test Name: Factor XII; Result Unstructured Data: Normal; Test Name: Bethesda assay; Result Unstructured Data: repeat BA showed eradication of the inhibitor; Test Name: Bethesda assay; Result Unstructured Data: Test Result:4.8 [beth'U]/mL;Bethesda assay; Test Name: C3 complement; Test Result: 87 mg/dL; Test Name: C4 complement; Test Result: 21 mg/dL; Test Name: CT abdomen; Result Unstructured Data: unremarkable; Test Name: CT scan pelvis; Result Unstructured Data: unremarkable; Test Name: CRP; Result Unstructured Data: less than 1mg/dL; Test Name: FVIII activity; Test Result: 1 %; Test Name: FVIII activity; Test Result: 2 %; Test Name: FVIII activity; Test Result: 6 %; Test Name: FVIII activity; Test Result: 22 %; Test Name: FVIII activity; Test Result: 60 %; Test Name: FVIII activity; Test Result: 125 %; Test Name: D-dimer; Result Unstructured Data: Test Result:457 ng/mL;Normal; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.4 g/L;Normocytic anaemia and baseline was15 g/L 2 years prior; Test Name: haemoglobin; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.2 g/L;at haematology clinic; Test Name: Inflammatory marker test; Result Unstructured Data: Normal; Test Name: INR; Result Unstructured Data: normal at 1.14; Test Name: INR; Result Unstructured Data: Normal at 1; Test Name: mixing assay; Result Unstructured Data: A 1:1 mixing assay showed aPTT 62.3 that fully corrected on immediate mix to 34.4, then prolonged to 44.8s on incubation, which suggested the presence of clotting factor inhibitors.; Test Name: liver function test; Result Unstructured Data: Normal; Test Name: platelet count; Result Unstructured Data: Test Result:236 10*9/L;Normal; Test Name: platelet count; Test Name: prostate-specific antigen level; Result Unstructured Data: less than 0.1ng/mL; Test Name: prostate-specific antigen level; Result Unstructured Data: less than 0.04ng/mL; Test Name: prothrombin time; Test Result: 12.7 s; Test Name: prothrombin time; Test Result: 11.3 s; Test Name: ESR; Test Name: kidney function test; Result Unstructured Data: Normal; Test Name: thyroid test; Result Unstructured Data: Repeat thyroid studies were normal.; Test Name: free thyroxine (FT4); Result Unstructured Data: Test Result:1.16 ng/dL;normal; Test Name: total triiodothyronine (T3); Result Unstructured Data: Test Result:66 ng/dL;mildly low; Test Name: vital signs; Result Unstructured Data: vital signs were normal, and he was well appearing.; Test Name: Von Willebrand Factor activity; Test Result: 147 %; Test Name: antigen; Test Result: 150 %; Test Name: Weight; Result Unstructured Data: unintentional 20 pound weight loss over 4 months; Test Name: white cell; Result Unstructured Data: Test Result:7.3 10*9/L;Normal