Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune haemolytic anaemia, Eye colour change, Fatigue, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: platelets were incredibly low at 16; RBC was 3.25; Autoimmune hemolytic anemia; Idiopathic thrombocytopenic purpura; yellowing of both eyes; felt tired/increasing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelets were incredibly low at 16), RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25), AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Mar-2021, the patient experienced FATIGUE (felt tired/increasing fatigue). On 27-Mar-2021, the patient experienced EYE COLOUR CHANGE (yellowing of both eyes). On 28-Mar-2021, the patient experienced PLATELET COUNT DECREASED (platelets were incredibly low at 16) (seriousness criteria hospitalization and medically significant) and RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25) (seriousness criteria hospitalization and medically significant). On 05-Apr-2021, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) (seriousness criterion medically significant) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criterion medically significant). On 16-Apr-2021, PLATELET COUNT DECREASED (platelets were incredibly low at 16) outcome was unknown. At the time of the report, RED BLOOD CELL COUNT ABNORMAL (RBC was 3.25), EYE COLOUR CHANGE (yellowing of both eyes) and FATIGUE (felt tired/increasing fatigue) outcome was unknown and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) and IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Platelet count decreased: 16 (Low) Low. On 28-Mar-2021, Red blood cell count: 3.25 (Low) Low. On 05-Apr-2021, Platelet count decreased: 90 (Inconclusive) 90. On 05-Apr-2021, Red blood cell count: 2.76 (Inconclusive) 2.76. On 16-Apr-2021, Platelet count decreased: 329 (Inconclusive) 329. On 16-Apr-2021, Red blood cell count: 3.47 (Inconclusive) 3.47.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   On either 23 Mar 2021 or 24 Mar 2021 (described as around the 5th or 6th day), the patient noticed bruises on both arms (described as 1 or 2 petechiae on chest, "a little bit on right leg," petechiae on both forearm but mostly on the left one, "a little bit on both arms but mostly on the left"). On 24Mar2021, the patient noticed a bruise on lower back. On 26 Mar 2021, the patient noticed bruising on both sides of both knees. On 27 Mar 2021, the patient had yellowing of both eyes. On 28 Mar 2021, the patient had increasing fatigue and saw their Nurse, who advised her to go to the emergency room to get blood tests. When the patient arrived at the emergency room, the patient had bruises on calves, and their platelets were incredibly low at 16, RBC was 3.25. While admitted, the patient had daily blood tests because the patient was notified that the "immune system started attacking red blood cells". The patient was initially treated with steroids, but didn't respond to steroids; then, the patient was treated with IVIG and responded. On 01 Apr 2021, the patient received a platelet transfusion and red blood cell transfusion. On 05 Apr 2021, the patient's platelets went up to 90, and RBCs were at 2.76. On 05 Apr 2021 around 1600, the patient was discharged with an official diagnosed with idiopathic thrombocytopenic purpura and autoimmune hemolytic anemia. On 16 Apr 2021, the patient's platelets were 329 and red blood cells were 3.47. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.