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 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: Private. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 abnormalities. On an unknown date, Flow cytometry: did not show any abnormalities. On an unknown date, Laboratory test: did not show any abnormalities. For mRNA-1273 (Moderna COVID-19 Vaccine) (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 did 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. In two cases the bone marrow was hypocellular and in two cases the bone marrow was acellular. 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 1st male patient who took Moderna vaccine. Company Comment: This literature-non-study case concerns an adult male patient with no medical history provided (although it was reported that some of the patients analyzed in study had a history of chronic conditions), who experienced the unexpected serious (medically significant) of aplastic anemia. The event occurred on an unknown date, after the second dose of mRNA-1273 (described as on average three weeks). As reported, the patient had no abnormalities on flow cytometry and molecular diagnostics and cytogenetic analysis showed diploid karyotype with no chromosomal abnormalities. 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 (results for specific patient were not provided but described that 2 patients had hypocellular while two acellular). All patients (including this patient described in this report) received combination immunosuppressive therapy with steroids, horse anti-thymocyte globulin, cyclosporine and eltrombopag. Outcome is unknown for this patient. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-648814 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow up received by safety on 21-SEP-2022 has email with detailed abstract and contains significant information: Literature information updated. Sender's Comments: This literature-non-study case concerns an adult male patient with no medical history provided (although it was reported that some of the patients analyzed in study had a history of chronic conditions), who experienced the unexpected serious (medically significant) of aplastic anemia. The event occurred on an unknown date, after the second dose of mRNA-1273 (described as on average three weeks). As reported, the patient had no abnormalities on flow cytometry and molecular diagnostics and cytogenetic analysis showed diploid karyotype with no chromosomal abnormalities. 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 (results for specific patient were not provided but described that 2 patients had hypocellular while two acellular). All patients (including this patient described in this report) received combination immunosuppressive therapy with steroids, horse anti-thymocyte globulin, cyclosporine and eltrombopag. Outcome is unknown for this patient. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-648814: Male patient 2.