Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hepatic enzyme, Hepatitis viral test, Immune thrombocytopenia, Influenza virus test
Clinical narrative: Idiopathic thrombocytopenic purpura; vaccination related malaise; fever; chills; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 (patient with history SARS-CoV2 viral infection 5 months earlier). Concurrent medical conditions included Hypertension (Patient with history of hypertension 5 months earlier).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criterion medically significant), VACCINATION COMPLICATION (vaccination related malaise), PYREXIA (fever) and CHILLS (chills). At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura), VACCINATION COMPLICATION (vaccination related malaise), PYREXIA (fever) and CHILLS (chills) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-platelet antibody: not present (Negative) Anti-platelet antibodies were not present.. On an unknown date, Blood creatine phosphokinase: 265 u/l 265 U/L. On an unknown date, Blood fibrinogen: 419 mg/dl 419 mg/dl. On an unknown date, Blood pressure measurement: 156/74 mmhg blood pressure in 156/74 mmHg. On an unknown date, Body temperature: 98.4 f (normal) 98.4 F. On an unknown date, Chest X-ray: normal (normal) Chest x-ray revealed no acute cardiopulmonary pathologies. On an unknown date, Fibrin D dimer: 0.48 ug/dl D-dimers in 0.48 ug/dl. On an unknown date, Haemoglobin: 14.5 g/dl 14.5 g/dL. On an unknown date, Haptoglobin: 93.6 mg/dl 93.6 mg/dl. On an unknown date, Heart rate: 68 bpm (normal) 68 BPM. On an unknown date, Hepatic enzyme: normal (normal) Normal. On an unknown date, Hepatitis viral test: non reactive (normal) Hepatitis A, B and C were nonreactive. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, Platelet count: 1x10^3/ul (Low) 1x10^3/ul and 108 x10^3/ul 108 x10^3/ul. On an unknown date, Red blood cell sedimentation rate: 14 mm/hr 14 mm/hr. On an unknown date, Red blood cells urine: 712/ul (High) Urinalysis showed elevated RBCs in 712/uL. On an unknown date, Renal function test: stable (normal) blood chemistry showed stable renal function, without electrolyte disturbances. On an unknown date, Respiratory rate: 18 /min (normal) 18 /min. On an unknown date, Respiratory syncytial virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Toxicologic test: negative (Negative) negative. On an unknown date, White blood cell count: 4.9 x 10^3/ul 4.9 x 10^3/ul.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura), VACCINATION COMPLICATION (vaccination related malaise), PYREXIA (fever) and CHILLS (chills) to be possibly related.    Patient developed small violaceous spots throughout his body, with associated fever, chills, general malaise, and dark urine, 3 days after receiving the second dose of the mRNA-1273 COVID-19 vaccine. He denied nausea, vomits, rhinorrhea, shortness of breath, cough, chest pain, abdominal pain, hematemesis, hematochezia, melena, or recent illness.  The patient was subsequently started on high dose IV steroids and transfused 2 units of platelet apheresis, increasing his platelets to 108 x10^3/ul. Based on the patient's clinical findings, the most likely diagnosis was idiopathic thrombocytopenic purpura (ITP), secondary to COVID-19 vaccine.  Idiopathic thrombocytopenic purpura was considered a diagnosis of exclusion in patients with isolated thrombocytopenia. Even though the drug of choice was corticosteroids, there was no cure, and the disease may relapse years after the initial episode  Company Comment: This case concerns a 61 year-old male patient with no relevant medical history, who experienced the unexpected serious event of idiopathic thrombocytopenic purpura (AESI). The event occurred 3 days after the second dose of mRNA-1273 vaccine. Extensive work-up ruled out other etiologies. The reporter considered the event to be related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Medically significant criteria maintained based on medical evaluation and treatment.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received by safety on 13-oct-2021 included an Email with FTA which contains no new information.; Sender's Comments: This case concerns a 61 year-old male patient with no relevant medical history, who experienced the unexpected serious event of idiopathic thrombocytopenic purpura (AESI). The event occurred 3 days after the second dose of mRNA-1273 vaccine. Extensive work-up ruled out other etiologies. The reporter considered the event to be related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Medically significant criteria maintained based on medical evaluation and treatment.