Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis viral, COVID-19, Full blood count, Immune thrombocytopenia, Influenza
Clinical narrative: numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or Coronavirus disease (COVID) infections/immune thrombocytopenic purpura (IT P) crisis/ITP exacerbations; petechial hemorrhages in mouth/blood spots in mouth; hyporesponsiveness; numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections; petechial rash on skin; numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections; numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections/contracted COVID; Platelet 6000 000; This spontaneous case was reported by a physician and describes the occurrence of IMMUNE THROMBOCYTOPENIA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or Coronavirus disease (COVID) infections/immune thrombocytopenic purpura (IT P) crisis/ITP exacerbations) and MOUTH HAEMORRHAGE (petechial hemorrhages in mouth/blood spots in mouth) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ROMIPLOSTIM (NPLATE) injection for Immune thrombocytopenia.    Previously administered products included for Immune thrombocytopenia: Promacta, IGG and Danazol. Past adverse reactions to the above products included No adverse event with Danazol, IGG and Promacta. Concurrent medical conditions included Thrombocytopaenic purpura.   In 2012, the patient started ROMIPLOSTIM (NPLATE) (Subcutaneous) 500 microgram once a week. In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, ROMIPLOSTIM (NPLATE) (Subcutaneous) dosage was changed to 500 microgram once a week. On 02-Jul-2021, ROMIPLOSTIM (NPLATE) (Subcutaneous) dosage was changed to 600 microgram once a week. On 30-Jul-2021, ROMIPLOSTIM (NPLATE) (Subcutaneous) dosage was changed to 700 microgram once a week. On 19-Aug-2021, ROMIPLOSTIM (NPLATE) (Subcutaneous) dosage was changed to 800 microgram once a week. On 17-Sep-2021, ROMIPLOSTIM (NPLATE) (Subcutaneous) dosage was changed to 900 microgram once a week. On 06-May-2021, the patient experienced PLATELET COUNT INCREASED (Platelet 6000 000). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or Coronavirus disease (COVID) infections/immune thrombocytopenic purpura (IT P) crisis/ITP exacerbations) (seriousness criteria hospitalization and medically significant), MOUTH HAEMORRHAGE (petechial hemorrhages in mouth/blood spots in mouth) (seriousness criterion hospitalization), THERAPEUTIC RESPONSE DECREASED (hyporesponsiveness), BRONCHITIS VIRAL (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections), PETECHIAE (petechial rash on skin), INFLUENZA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections) and COVID-19 (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections/contracted COVID). The patient was hospitalized from 04-May-2021 to 02-Jun-2021 due to IMMUNE THROMBOCYTOPENIA and MOUTH HAEMORRHAGE. The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, MOUTH HAEMORRHAGE (petechial hemorrhages in mouth/blood spots in mouth) had resolved. At the time of the report, IMMUNE THROMBOCYTOPENIA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or Coronavirus disease (COVID) infections/immune thrombocytopenic purpura (IT P) crisis/ITP exacerbations), THERAPEUTIC RESPONSE DECREASED (hyporesponsiveness), BRONCHITIS VIRAL (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections), PETECHIAE (petechial rash on skin), INFLUENZA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections) and COVID-19 (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections/contracted COVID) outcome was unknown and PLATELET COUNT INCREASED (Platelet 6000 000) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Platelet count: 600000 (abnormal) abnormal. On 31-May-2021, Platelet count: 8000 (abnormal) abnormal. On 03-Jun-2021, Platelet count: 231000 (abnormal) abnormal. On 05-Jun-2021, Platelet count: 600,000 (abnormal) abnormal. On 10-Jun-2021, Platelet count: 261000 (abnormal) abnormal. In 2021, Platelet count: 14000 (abnormal) abnormal and 53000 (abnormal) abnormal. On 17-Jun-2021, Platelet count: 84000 (abnormal) abnormal. On 23-Jun-2021, Platelet count: 92000 (abnormal) abnormal. On 02-Jul-2021, Platelet count: 64000 (abnormal) abnormal. On 08-Jul-2021, Platelet count: 61000 (abnormal) abnormal. On 15-Jul-2021, Platelet count: 91000 (abnormal) abnormal. On 22-Jul-2021, Platelet count: 51000 (abnormal) abnormal. On 29-Jul-2021, Platelet count: 36000 (abnormal) abnormal. On 05-Aug-2021, Platelet count: 76000 (abnormal) abnormal. On 12-Aug-2021, Platelet count: 45000 (abnormal) abnormal. On 18-Aug-2021, Platelet count: 36000 (abnormal) abnormal. On 27-Aug-2021, Platelet count: 67000 (abnormal) abnormal. On 02-Sep-2021, Platelet count: 56000 (abnormal) abnormal. On 09-Sep-2021, Platelet count: 50000 (abnormal) abnormal. On 14-Sep-2021, Full blood count: 14,000 (abnormal) absent. On 15-Sep-2021, Platelet count: 18000 (abnormal) abnormal. On 23-Sep-2021, Platelet count: 106000 (abnormal) abnormal. On 28-Sep-2021, Platelet count: 73000 (abnormal) abnormal.     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 (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or Coronavirus disease (COVID) infections/immune thrombocytopenic purpura (IT P) crisis/ITP exacerbations) to be possibly related. No further causality assessments were provided for MOUTH HAEMORRHAGE (petechial hemorrhages in mouth/blood spots in mouth), THERAPEUTIC RESPONSE DECREASED (hyporesponsiveness), BRONCHITIS VIRAL (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections), PETECHIAE (petechial rash on skin), INFLUENZA (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections), COVID-19 (numerous flares throughout his treatment with Nplate that were a result of viral bronchitis, influenza or COVID infections/contracted COVID) and PLATELET COUNT INCREASED (Platelet 6000 000).    The physician reported that the event therapeutic response decreased was possibly related to Nplate. The physician reported that the event immune thrombocytopenia was not related to Nplate. The physician reported that the event immune thrombocytopenia was possibly related to COVID-19 Vaccine Moderna. The causal relationship between the events bronchitis viral, influenza, COVID-19, mouth haemorrhage, petechiae, wrong technique in product usage process, and Nplate was not provided by the physician. No concomitant product was provided. Company comment: This is a spontaneous case concerning a 58-year-old, male patient with medical history of Immune Thrombocytopenia, who experienced the unexpected serious (hospitalization and AESI) events of Immune Thrombocytopenia crisis and mouth hemorrhage along with other non serious events including the AESI event of COVID 19 and petechiae. The event occurred with unclear time to onset from the first dose of Moderna COVID 19 vaccine.  Patient has history of immune thrombocytopenia in treatment with Romiplostim since 2012 with some exacerbations induced by infections.  In May he was hospitalized due to petechial heamorraghe in the mouth and thrombocytopenia. Received treatment with Prednisone and presented multiple relapses of thrombocytopenia ever since. Also an episode of platelet count increased were Romiplostim was discontinued and then reinitiated. It is not clear by the report if the event COVID 19 was after de vaccination and no information regarding the second dose has been disclosed, so no lack of efficacy was captured. The rechallenge is not applicable. The medical history of Immune Thrombocytopenia is a confounder for the events and romiplostim is a co suspect for the event platelet count increased.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old, male patient with medical history of Immune Thrombocytopenia, who experienced the unexpected serious (hospitalization and AESI) events of Immune Thrombocytopenia crisis and mouth hemorrhage along with other non serious events including the AESI event of COVID 19 and petechiae. The event occurred with unclear time to onset from the first dose of Moderna COVID 19 vaccine.  Patient has history of immune thrombocytopenia in treatment with Romiplostim since 2012 with some exacerbations induced by infections.  In May he was hospitalized due to petechial heamorraghe in the mouth and thrombocytopenia. Received treatment with Prednisone and presented multiple relapses of thrombocytopenia ever since. Also an episode of platelet count increased were Romiplostim was discontinued and then reinitiated. It is not clear by the report if the event COVID 19 was after de vaccination and no information regarding the second dose has been disclosed, so no lack of efficacy was captured. The rechallenge is not applicable. The medical history of Immune Thrombocytopenia is a confounder for the events and romiplostim is a co suspect for the event platelet count increased.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.