Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation factor XI level, Computerised tomogram head, Haematology test, Investigation, Laboratory test
Clinical narrative: Spontaneous intracerebral hemorrhage due to acquired Factor IX and XI clotting disorder; Acquired factor IX deficiency; Acquired factor XI deficiency; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL HAEMORRHAGE (Spontaneous intracerebral hemorrhage due to acquired Factor IX and XI clotting disorder), ACQUIRED FACTOR IX DEFICIENCY (Acquired factor IX deficiency) and ACQUIRED FACTOR XI DEFICIENCY (Acquired factor XI deficiency) in an 83-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Spontaneous intracerebral hemorrhage due to acquired Factor IX and XI clotting disorder) (seriousness criteria hospitalization and medically significant), ACQUIRED FACTOR IX DEFICIENCY (Acquired factor IX deficiency) (seriousness criteria hospitalization and medically significant) and ACQUIRED FACTOR XI DEFICIENCY (Acquired factor XI deficiency) (seriousness criteria hospitalization and medically significant). The patient was treated with CYCLOPHOSPHAMIDE at an unspecified dose and frequency; RITUXIMAB at an unspecified dose and frequency; PREDNISONE at a dose of High Dose and Rehabilitation therapy (patinet transfered to inpatient rehab facility) for Cerebral haemorrhage. At the time of the report, CEREBRAL HAEMORRHAGE (Spontaneous intracerebral hemorrhage due to acquired Factor IX and XI clotting disorder), ACQUIRED FACTOR IX DEFICIENCY (Acquired factor IX deficiency) and ACQUIRED FACTOR XI DEFICIENCY (Acquired factor XI deficiency) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti factor IX antibody: Positive. On an unknown date, Antinuclear antibody: unremarkable. On an unknown date, Coagulation factor XI level: Positive. On an unknown date, Computerised tomogram head: showed expansion of the bleed in the right subinsular region and concern for new subfalcine and uncal herniation. On an unknown date, Haematology test: Hematology was consulted and recommended mixing studies which did not correct, and Bethesda assay showing an acquired inhibitor of factor IX and XI. On an unknown date, Investigation: unremarkable. On an unknown date, Laboratory test: Labs revealed an acute coagulopathy.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered CEREBRAL HAEMORRHAGE (Spontaneous intracerebral hemorrhage due to acquired Factor IX and XI clotting disorder), ACQUIRED FACTOR IX DEFICIENCY (Acquired factor IX deficiency) and ACQUIRED FACTOR XI DEFICIENCY (Acquired factor XI deficiency) to be related.    Concomitant medication were not reported.  The patient received his last dose of the Moderna vaccine one month prior to admission due to spontaneous intracerebral hemorrhage (ICH).   After performing CT head patient was transferred to the Neurosurgical ICU for further conservative management and then transferred to inpatient rehab facility.  It was stated that patient was vaccinated which was confirmed with positive COVID spike protein testing.  Patient continued to have worsening weakness and dysphagia during his acute hospital admission and ultimately pursued comfort care.  As per author ICH occurred due to acquired Factor IX and XI clotting disorder from COVID-19 vaccination.  Author concluded that acquired coagulopathy can occur after COVID-19 vaccine inducing a spontaneous hemorrhage and should be considered as part of the etiologies of ICH.  Company comment: This literature non study case concerns a 83 year-old, male patient with no medical history information reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of Cerebral haemorrhage and serious unexpected events of acquired factor IX deficiency and acquired factor XI deficiency (described as spontaneous intracerebral hemorrhage due to acquired factor IX and XI clotting disorder). The events occurred approximately 1 month after a dose of mRNA-1273. As reported, the patient was admitted with a spontaneous intracerebral hemorrhage managed conservatively before transfer to inpatient rehab facility. During his rehabilitation stay, he was found to have worsening left side weakness with concern for new spontaneous hemorrhage (ICH). CT head showed expansion of the bleed in the right subinsular region and concern for new subfalcine and uncal herniation. Labs revealed an acute coagulopathy. Hematology was consulted and recommended mixing studies which did not correct, and Bethesda assay showing an acquired inhibitor of factor IX and XI. Malignancy workup and autoimmune titers were unremarkable. Patient was placed on cyclophosphamide, rituximab, and high dose prednisone. He continued to have worsening weakness and dysphagia during his acute hospital admission and ultimately pursued comfort care. As stated by the authors, with unknown etiology, it was postulated that this may be vaccine related as patient received his last dose of the Moderna vaccine one month prior to admission for ICB. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Live follow-up received on 08-Dec-2022 contains no new information.; Sender's Comments: This literature non study case concerns a 83 year-old, male patient with no medical history information reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of Cerebral haemorrhage and serious unexpected events of acquired factor IX deficiency and acquired factor XI deficiency (described as spontaneous intracerebral hemorrhage due to acquired factor IX and XI clotting disorder). The events occurred approximately 1 month after a dose of mRNA-1273. As reported, the patient was admitted with a spontaneous intracerebral hemorrhage managed conservatively before transfer to inpatient rehab facility. During his rehabilitation stay, he was found to have worsening left side weakness with concern for new spontaneous hemorrhage (ICH). CT head showed expansion of the bleed in the right subinsular region and concern for new subfalcine and uncal herniation. Labs revealed an acute coagulopathy. Hematology was consulted and recommended mixing studies which did not correct, and Bethesda assay showing an acquired inhibitor of factor IX and XI. Malignancy workup and autoimmune titers were unremarkable. Patient was placed on cyclophosphamide, rituximab, and high dose prednisone. He continued to have worsening weakness and dysphagia during his acute hospital admission and ultimately pursued comfort care. As stated by the authors, with unknown etiology, it was postulated that this may be vaccine related as patient received his last dose of the Moderna vaccine one month prior to admission for ICB. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.