Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Platelet count, Skin haemorrhage, Thrombocytopenia, Vaginal haemorrhage
Clinical narrative: 0 platelet count; red spots on wrists and ankles causing bleeding under the skin; heavy vaginal bleeding; red spots on wrists and ankles causing bleeding under the skin; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (0 platelet count), ERYTHEMA (red spots on wrists and ankles causing bleeding under the skin), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and SKIN HAEMORRHAGE (red spots on wrists and ankles causing bleeding under the skin) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (0 platelet count) (seriousness criteria hospitalization and medically significant), ERYTHEMA (red spots on wrists and ankles causing bleeding under the skin) (seriousness criteria hospitalization and medically significant), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) (seriousness criteria hospitalization and medically significant) and SKIN HAEMORRHAGE (red spots on wrists and ankles causing bleeding under the skin) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to ERYTHEMA, SKIN HAEMORRHAGE, THROMBOCYTOPENIA and VAGINAL HAEMORRHAGE. At the time of the report, THROMBOCYTOPENIA (0 platelet count), ERYTHEMA (red spots on wrists and ankles causing bleeding under the skin), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and SKIN HAEMORRHAGE (red spots on wrists and ankles causing bleeding under the skin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 0 (Low) 0 platelet..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. She spent four days in the hospital with platelet transfusions, antibodies and steroids to restore her platelet count. Company comment: This case concerns a 48-year old, female subject with no  relevant medical history, who experienced the serious unexpected events of Thrombocytopenia(AESI), Erythema, and Vaginal Haemorrhage. The event Vaginal haemorrhage occurred two weeks after the first dose of mRNA 1273 VACCINE while events Thrombocytopenia and Skin haemorrhage occurred unknown number of days after the first dose of mRNA 1273 VACCINE. Emergency room visit, where platelet count was confirmed to be zero, with subsequent hospitalization for 4 days and treatment with platelet transfusions, antibodies and steroids transpired. At the time of the report, outcomes of the events were unknown. Rechallenge is not applicable as events happened after the first dose. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Based on medical judgement, all the events are also considered medically significant because, aside from hospitalization, they required treatment to prevent more serious consequences of uncontrolled haemorrhage.; Sender's Comments: This case concerns a 48-year old, female subject with no  relevant medical history, who experienced the serious unexpected events of Thrombocytopenia(AESI), Erythema, and Vaginal Haemorrhage. The event Vaginal haemorrhage occurred two weeks after the first dose of mRNA 1273 VACCINE while events Thrombocytopenia and Skin haemorrhage occurred unknown number of days after the first dose of mRNA 1273 VACCINE. Emergency room visit, where platelet count was confirmed to be zero, with subsequent hospitalization for 4 days and treatment with platelet transfusions, antibodies and steroids transpired. At the time of the report, outcomes of the events were unknown. Rechallenge is not applicable as events happened after the first dose. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Based on medical judgement, all the events are also considered medically significant because, aside from hospitalization, they required treatment to prevent more serious consequences of uncontrolled haemorrhage.