Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 041L20A | IM |
fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL); Myelodysplastic Syndromes (MDS); This spontaneous case was reported by a patient and describes the occurrence of MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) and THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 030M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In September 2024, the patient experienced MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) (seriousness criterion medically significant). In January 2025, the patient experienced THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) (seriousness criterion medically significant). At the time of the report, MYELODYSPLASTIC SYNDROME (Myelodysplastic Syndromes (MDS)) and THROMBOCYTOPENIA (fluctuating thrombocytopenia (platelet counts between 35,000-60,000/µL)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: platelet counts between 35,000-60,000/µL (low) since Jan-2025. No concomitant medications were reported. The patient was diagnosed with Myelodysplastic Syndromes (MDS) in September 2024, and had been monitoring his health closely, particularly his thrombocytopenia (low platelet counts), which had fluctuated between 35,000 and 60,000/AµL since January 2025. His healthcare team guided his ongoing treatment decisions, which included exploring RUNX1-targeted clinical trials due to his genetic mutations (PHF6, BCOR, RUNX1). The patient was exploring all possible factors that might had influenced the patient's condition, including the vaccines that the patient received in 2021.; Reporter's Comments: The patient's genetic mutations (PHF6, BCOR, RUNX1) remain as confounders for the events. The benefit-risk relationship of the product is not affected by this report.
Test Name: Platelet; Result Unstructured Data: platelet counts between 35,000-60,000/µL (low) since Jan-2025