Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aplasia pure red cell, Full blood count
Clinical narrative: she was recently diagnosed with pure red blood cell aplasia (PRCA); This spontaneous case was reported by a consumer and describes the occurrence of APLASIA PURE RED CELL (she was recently diagnosed with pure red blood cell aplasia (PRCA)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21D) for COVID-19 vaccination.     The patient's past medical history included Heart attack (She has a history of a heart attack 6 years ago) in 2015.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, 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 experienced APLASIA PURE RED CELL (she was recently diagnosed with pure red blood cell aplasia (PRCA)) (seriousness criterion medically significant). The patient was treated with CYCLOSPORINE ongoing from November 2021 for Adverse event, at a dose of 150 mg twice a day; PREDNISONE ongoing from November 2021 for Adverse event, at a dose of 30 mg once a day; SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) ongoing from November 2021 for Adverse event, at a dose of MWF and PANTOPRAZOLE ongoing from November 2021 for Adverse event, at a dose of 40 mg once a day. At the time of the report, APLASIA PURE RED CELL (she was recently diagnosed with pure red blood cell aplasia (PRCA)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Full blood count: abnormal (abnormal) 8. and abnormal (abnormal) Physician wanted to have it rechecked and it came back at 7. In November 2021, Full blood count: abnormal (abnormal) 6 (two weeks ago). On an unknown date, Full blood count: 15 (normal) Blood work done every month and it always came 15.         No relevant concomitant medications were reported. She began having symptoms of being out of breath, couldn't walk to kitchen, no energy, no pink in cuticles or eyelids in September of 2021. Her blood count was always 15 but it September it came back at 8, so her doctor wanted her to have it rechecked & it came back at 7.  They thought she had a GI bleed at first.  Two weeks ago it was 6. She says that she was recently diagnosed with pure red blood cell aplasia (PRCA).    Company comment: This spontaneous case concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Aplasia pure red cell after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included dyspnoea, asthenia and pallor. Blood count was reported between 6 and 9, which probably refers to haemoglobin level. Treatment with cyclosporine and prednisone was prescribed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Aplasia pure red cell after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included dyspnoea, asthenia and pallor. Blood count was reported between 6 and 9, which probably refers to haemoglobin level. Treatment with cyclosporine and prednisone was prescribed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.