Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, International normalised ratio, Magnetic resonance imaging, Platelet count, Prothrombin level
Clinical narrative: Complicated ITP; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Complicated ITP) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNE THROMBOCYTOPENIA (Complicated ITP) (seriousness criterion medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Adverse event, at a dose of 1 dosage form and ROMIPLOSTIM (NPLATE) for Adverse event, at a dose of 1 dosage form. At the time of the report, IMMUNE THROMBOCYTOPENIA (Complicated ITP) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: ana positive and weakly positive for anti-ssa (Positive) ANA positive and weakly positive for Anti-SSA. On an unknown date, Blood smear test: did not show abnormal rbc morphology and ldh and h Did not show abnormal RBC morphology and LDH and haptoglobin were normal.. On an unknown date, Blood thromboplastin: normal (normal) normal. On an unknown date, Computerised tomogram head: unremarkable (normal) Unremarkable and two 0.4cm hemorrhagic foci in the right temporal a (abnormal) Two 0.4cm hemorrhagic foci in the right temporal and left frontal lobes. On an unknown date, Haemoglobin: 13 13, Thrombocytopenia and 7.6 (Low) Fallen from 13 to 7.6. On an unknown date, International normalised ratio: normal (normal) normal. On an unknown date, Magnetic resonance imaging: two 0.4cm hemorrhagic foci in the right temporal a (abnormal) Two 0.4cm hemorrhagic foci in the right temporal and left frontal lobes. On an unknown date, Platelet count: 2000 (Low) 2000, Thrombocytopenia, 0 (Low) Post transfusion, platelet count had fallen to 0, 1000 (Low) On day 4, the PLT count was 1000, 9000 (Low) 9000, 35000 (Low) On day 6, platelet count had risen to 35000, 132,000 (Low) 132,000 on day 8 and 326,000 (normal) 326,000. On an unknown date, Prothrombin level: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Complicated ITP) to be related.    Concomitant medications were not reported. Company comment:This is a literature case that concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected serious AESI event IMMUNE THROMBOCYTOPENIA (serious criteria medically significant) which occurred 48 hours  after receiving  a dose of mRNA-1273 Vaccine. The patient had complaint of headache, bleeding gums on brushing her teeth, petechiae ,headache and rectal bleeding. Lab investigations revealed severe thrombocytopenia. Post transfusion, platelet count had fallen to 0. A CT brain and MRI showed two 0.4cm hemorrhagic foci in the right temporal and left frontal lobes, but with no neurological deficits. With multiple platelets transfusion, pulse dose steroids, IVIG  and Nplate (thrombopoietin receptor agonist)  restored the platelet count to  previous baseline.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a literature case that concerns a 53-year-old female patient with no medical history reported, who experienced the unexpected serious AESI event IMMUNE THROMBOCYTOPENIA (serious criteria medically significant) which occurred 48 hours  after receiving  a dose of mRNA-1273 Vaccine. The patient had complaint of headache, bleeding gums on brushing her teeth, petechiae ,headache and rectal bleeding. Lab investigations revealed severe thrombocytopenia. Post transfusion, platelet count had fallen to 0. A CT brain and MRI showed two 0.4cm hemorrhagic foci in the right temporal and left frontal lobes, but with no neurological deficits. With multiple platelets transfusion, pulse dose steroids, IVIG  and Nplate (thrombopoietin receptor agonist)  restored the platelet count to  previous baseline.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.