Sex: M
Vaccine: COVID19
Symptoms: Aplastic anaemia, Cytogenetic analysis, Flow cytometry, Laboratory test
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of APLASTIC ANAEMIA (Aplastic anemia) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Pancytopenia since 2021. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced APLASTIC ANAEMIA (Aplastic anemia) (seriousness criterion medically significant). The patient was treated with CYCLOSPORINE at an unspecified dose and frequency and ELTROMBOPAG at an unspecified dose and frequency. At the time of the report, APLASTIC ANAEMIA (Aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cytogenetic analysis: Cytogenetics showed a diploid karyotype with no chromosomal. On an unknown date, Flow cytometry: Flow cytometry was not showed any abnormalities. On an unknown date, Laboratory test: molecular diagnostics was not showed any abnormalities.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered APLASTIC ANAEMIA (Aplastic anemia) to be related.    Concomitant medications were not reported.  All patients were male with a median age of 56 years   Patient had not developed any symptoms after the first dose of the vaccine. Symptoms occurred on average three weeks after the second vaccine.  Most common symptoms were fatigue, bruising and bleeding, development of petechiae, dizziness and shortness of breath.  Specific autoimmune workup was done and all patients received baseline bone marrow aspiration.  All patients received combination immunosuppressive therapy with steroids, horse anti-thymocyte globulin, cyclosporine and eltrombopag.  Patients were on therapy for a median of 26 weeks.  This case refers to 2nd male patient who took Moderna vaccine.  Company comment: This literature non study case concerns a male patient in the age group of 19- 69 years with no specific medical history, who experienced the unexpected serious (medically significant) event of Aplastic anaemia, after about 3 weeks of receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had not developed any symptoms after the first dose of the vaccine. Specific autoimmune workup was done. Cytogenetics showed a diploid karyotype with no chromosomal abnormalities. Flow cytometry and molecular diagnostics did not show any abnormalities. He received combination immunosuppressive therapy with steroids, horse anti-thymocyte globulin, cyclosporine and eltrombopag. No specific information on risk factors, co morbidities, detailed clinical course and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2022-648013 (E2B Linked Report).; Sender's Comments: This literature non study case concerns a male patient in the age group of 19- 69 years with no specific  medical history, who experienced the unexpected serious (medically significant) event of Aplastic anemia, after about 3 weeks of receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had not developed any symptoms after the first dose of the vaccine. Specific autoimmune workup was done. Cytogenetics showed a diploid karyotype with no chromosomal abnormalities. Flow cytometry and molecular diagnostics did not show any abnormalities. He received combination immunosuppressive therapy with steroids, horse anti-thymocyte globulin, cyclosporine and eltrombopag. No specific information on risk factors, co morbidities, detailed clinical course and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. MODERNATX, INC.-MOD-2022-648013:Male patient 1