Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: encephalopathy with facial muscle weakness; facial muscle weakness; back pain causing inability to ambulate; dysarthria; Constipation; urinary retention; MSSA; extremity weakness; Severe refractory immune thrombocytopenia; ACUTE EPISTAXIS; DIFFUSE CUTANEOUS PURPURA; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness), ENCEPHALOPATHY (encephalopathy with facial muscle weakness), FACIAL PARESIS (facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. Journal of Blood Medicine. 2021;12:221-224     Previously administered products included for Influenza immunization: influenza in October 2020; for Pneumococcal immunization: pneumococcal in December 2020. Past adverse reactions to the above products included No adverse event with influenza and pneumococcal. Concurrent medical conditions included Hypertension, Gout, Hyperlipidemia and Cardiomyopathy.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (ACUTE EPISTAXIS) (seriousness criterion hospitalization) and PURPURA (DIFFUSE CUTANEOUS PURPURA) (seriousness criterion hospitalization). On 20-Jan-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia) (seriousness criterion hospitalization). On 31-Jan-2021, the patient experienced MUSCULAR WEAKNESS (extremity weakness) (seriousness criterion hospitalization), ENCEPHALOPATHY (encephalopathy with facial muscle weakness) (seriousness criterion hospitalization), FACIAL PARESIS (facial muscle weakness) (seriousness criterion hospitalization), BACK PAIN (back pain causing inability to ambulate) (seriousness criterion hospitalization), DYSARTHRIA (dysarthria) (seriousness criterion hospitalization), CONSTIPATION (Constipation) (seriousness criterion hospitalization), URINARY RETENTION (urinary retention) (seriousness criterion hospitalization) and STAPHYLOCOCCAL SEPSIS (MSSA) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to EPISTAXIS, IMMUNE THROMBOCYTOPENIA, MUSCULAR WEAKNESS and PURPURA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness) and FACIAL PARESIS (facial muscle weakness) was resolving and ENCEPHALOPATHY (encephalopathy with facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Platelet count: 10 10^9/L (Inconclusive) 10. On 01-Feb-2021, Blood culture: abnormal (abnormal) blood culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Culture urine: abnormal (abnormal) urine culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Platelet count: 21 10^9/L (Inconclusive) 21. On 02-Feb-2021, Cytomegalovirus test: negative (Negative) Negative. On 02-Feb-2021, Epstein-Barr virus test: negative (Negative) Negative. On 02-Feb-2021, HIV test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis B virus test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis C virus test: negative (Negative) Negative. On 02-Feb-2021, Parvovirus B19 test: negative (Negative) Negative. On 04-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) MRI revealed sever L1-5 stenosis with multi-level disc herniation and fluid collections within the lumbar, posterior and paraspinal musculature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Two months prior to vaccination, the patient had a platelet count of 224 x 10^9/L.  No concomitant medications were reported.  Treatment for the events included high-dose dexamethasone (400mg/kg/day), five daily doses of intravenous immunoglobulin (400mg/kg/day), three daily platelet transfusions, and two weekly doses of rituximab (375mg/m^2/dose). Immune suppression with dexamethasone (20mg/day) was continued after hospital discharge. Post vaccination day ten, TPO-RA eltrombopag (50 mg/day) was initiated. On post-vaccination day 14, he received one pheresis unit of platelets and an additional dose of IVIg of 80 grams. On post-vaccination day 12, he received high dose methyl-prednisolone (1 mg/kg/day) and (5 mcg/kg). The patient was given cefazolin for MSSA infection. On post-vaccination day 19, after the third episode of plasma exchange, his facial weakness improved. On post-vaccination day 22, his platelet count was 72*10^9/L, a second dose of romiplostim 5 mcg/kg was administered, and a corticosteroid taper was begun. He was transferred to a skilled nursing facility on post-vaccination day 25 with a platelet count of 173*10^9/L.  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.