Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immune thrombocytopenia, Oral blood blister, Platelet count, Rash macular
Clinical narrative: ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000; hearing white noise in her head; she would sleep 10 to 12 hours a day; extreme tiredness; red spots on her lower legs; blood blisters in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced RASH MACULAR (red spots on her lower legs) and ORAL BLOOD BLISTER (blood blisters in her mouth). On 02-Jun-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TINNITUS (hearing white noise in her head), SOMNOLENCE (she would sleep 10 to 12 hours a day) and FATIGUE (extreme tiredness). The patient was treated with RITUXIMAB at a dose of 1 dosage form; IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) at a dose of 1 dosage form and PLATELETS at a dose of 1 dosage form. At the time of the report, IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) and TINNITUS (hearing white noise in her head) had not resolved and SOMNOLENCE (she would sleep 10 to 12 hours a day), RASH MACULAR (red spots on her lower legs), ORAL BLOOD BLISTER (blood blisters in her mouth) and FATIGUE (extreme tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Platelet count: 4000 (Inconclusive) 4000. On 06-Jun-2021, Platelet count: 50000 (Inconclusive) 50000. On 08-Jun-2021, Platelet count: 4000 (Inconclusive) 4000. On 25-Jun-2021, Platelet count: 5000 (Inconclusive) 5000.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. concomitant medication included steroids.  Patient called to report what she experienced after her 2nd Moderna Covid-19 Vaccine on 19May2021 (lot number 013M20A). She received both injections in her left arm. She began having extreme tiredness a week after the 2nd dose & she would sleep 10 to 12 hours a day. On 1Jun2021 she had red spots on her lower legs and blood blisters in her mouth. On 2Jun2021 she was admitted to the hospital and diagnosed with ITP, which she did not know what that stands for, and had a blood platelet count of 4000. She was given 3 bags of platelets, steroids, and IVIG as treatment. On 6Jun2021 she was released from the hospital with blood count of 50000. On 8Jun2021 she was hospitalized again with her platelet count back down to 4000 and was hospitalized for 6 more days on very high doses of steroids. During this 2nd hospitalization, she started hearing white noise in her head & it is ongoing. She was released from the hospital on 14Jun2021. On 25Jun2021 she was again admitted to the hospital with her platelets down to 5000. She was released from the hospital again on 27Jun2021. She is still on daily steroids & weekly treatments of Rituximab. She states that she has has no cancers no autoimmune disorders.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.