Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Diagnosis of aplastic anemia; May also have had covid during the hospital stay; This spontaneous case was reported by a patient and describes the occurrence of APLASTIC ANAEMIA (Diagnosis of aplastic anemia) and COVID-19 (May also have had covid during the hospital stay) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 031L20A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced APLASTIC ANAEMIA (Diagnosis of aplastic anemia) (seriousness criteria hospitalization and medically significant) and COVID-19 (May also have had covid during the hospital stay) (seriousness criterion hospitalization). The patient was hospitalized for 49 days due to APLASTIC ANAEMIA and COVID-19. At the time of the report, APLASTIC ANAEMIA (Diagnosis of aplastic anemia) and COVID-19 (May also have had covid during the hospital stay) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: broke down platelets to 7 broke down platelets to 7.         No concomitant products were reported Treatment received with the cancer clinic for aplastic anemia. Patient has any allergies reported as No.  It was reported that The patient stated that the booster dose was the one that broke down her platelets to 7 and stated that the 3rd dose booster was not too good for her.  The patient stated that they never nailed down why patient had aplastic anemia as patient did not have a problem with her platelets before.  The patient stated that when she was in the hospital for 7 weeks for the diagnosis of aplastic anemia.  Company comment: This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Aplastic anaemia, and unexpected serious (hospitalization) AESI of Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine (booster). The patient was admitted for 7 weeks to investigate the cause for aplastic anaemia and apparently no cause could be found. The outcome of events was reported as unknown. Details of concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. Elderly age of the patient could be a risk factor. Covid-19 infection could be a confounder for the event of Aplastic anaemia. The current pandemic situation of Covid-19 could be a confounder for the event of Covid-19. Eight months prior to the third dose, the patient has received two primary doses of mRNA-1273 vaccine and similar events were not reported after receiving them. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Aplastic anaemia, and unexpected serious (hospitalization) AESI of Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine (booster). The patient was admitted for 7 weeks to investigate the cause for aplastic anaemia and apparently no cause could be found. The outcome of events was reported as unknown. Details of concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. Elderly age of the patient could be a risk factor. Covid-19 infection could be a confounder for the event of Aplastic anaemia. The current pandemic situation of Covid-19 could be a confounder for the event of Covid-19. Eight months prior to the third dose, the patient has received two primary doses of mRNA-1273 vaccine and similar events were not reported after receiving them. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.