Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Contusion, Immune thrombocytopenia, Platelet count
Clinical narrative: Diagnosed with Immune Thrombocytopenia; having constant bruising all over the body; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with Immune Thrombocytopenia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 008B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient was totally healthy prior to vaccination.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced CONTUSION (having constant bruising all over the body). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with Immune Thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with Immune Thrombocytopenia) and CONTUSION (having constant bruising all over the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Platelet count: down to 13000 (Low) down to 13000. On 15-Apr-2022, Biopsy bone marrow: results not reported Results not reported.         No concomitant medications were reported.  Company Comment: This spontaneous case concerns a 67-year-old, male patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of immune thrombocytopenia and the unexpected, non-serious event of contusion after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Of note, the patient received three doses of the Moderna mRNA-1273 vaccine. After receiving the second dose, it was reported that the patient started to easily bruise and had blisters in the mouth. No further details were provided. It is unknown if these events had resolved. After receiving the booster dose, the patient experienced constant bruising all over the body. It was reported that the patient's platelet count was down to 13,000. The patient sought consult on an unspecified date and was diagnosed with Immune Thrombocytopenia. A Bone Marrow biopsy was done on 15Apr2022 which was approximately 3 months after receiving the booster dose, however, the result was not provided. The patient was given unspecified steroids and it was reported that the patient was not responding. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-541674 (Patient Link).; Sender's Comments: This spontaneous case concerns a 67-year-old, male patient with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of immune thrombocytopenia and the unexpected, non-serious event of contusion after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Of note, the patient received three doses of the Moderna mRNA-1273 vaccine. After receiving the second dose, it was reported that the patient started to easily bruise and had blisters in the mouth. No further details were provided. It is unknown if these events had resolved. After receiving the booster dose, the patient experienced constant bruising all over the body. It was reported that the patient's platelet count was down to 13,000. The patient sought consult on an unspecified date and was diagnosed with Immune Thrombocytopenia. A Bone Marrow biopsy was done on 15Apr2022 which was approximately 3 months after receiving the booster dose, however, the result was not provided. The patient was given unspecified steroids and it was reported that the patient was not responding. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.