Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Fatigue, Gait disturbance
Clinical narrative: Fatigue worsened; weakness; Extreme difficulty walking; Reaction to Moderna Covid booster; Blood pressure 165/90; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue worsened), ASTHENIA (weakness), GAIT DISTURBANCE (Extreme difficulty walking), VACCINATION COMPLICATION (Reaction to Moderna Covid booster) and BLOOD PRESSURE INCREASED (Blood pressure 165/90) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MIFEPRISTONE (KORLYM) for Cushings syndrome.    Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Chronic kidney disease, Hyperlipidaemia and Cushings syndrome. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE, CANDESARTAN, CARVEDILOL, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), FUROSEMIDE, GLIMEPIRIDE, CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), TRANDOLAPRIL, DULAGLUTIDE (TRULICITY), VERAPAMIL, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for an unknown indication.   On 12-Oct-2019, the patient started MIFEPRISTONE (KORLYM) (Oral) 300 mg once a day. On 25-Oct-2019, MIFEPRISTONE (KORLYM) (Oral) dosage was changed to 600 mg once a day. On 09-Feb-2021, MIFEPRISTONE (KORLYM) (Oral) dosage was changed to 600 mg once a day. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, MIFEPRISTONE (KORLYM) (Oral) dosage was changed to 300 mg once a day and MIFEPRISTONE (KORLYM) (Oral) dosage was changed to 600 mg once a day. On an unknown date, the patient experienced FATIGUE (Fatigue worsened) (seriousness criteria hospitalization and medically significant), ASTHENIA (weakness) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (Extreme difficulty walking) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (Reaction to Moderna Covid booster) (seriousness criteria hospitalization and medically significant) and BLOOD PRESSURE INCREASED (Blood pressure 165/90) (seriousness criteria hospitalization and medically significant). The patient was treated with Physical therapy (occupational therapy) for Fatigue; Physical therapy (occupational therapy) for Asthenia; Physical therapy (occupational therapy) for Gait disturbance; Physical therapy (occupational therapy) for Vaccination complication and Physical therapy (occupational therapy) for Blood pressure increased. At the time of the report, FATIGUE (Fatigue worsened), ASTHENIA (weakness), GAIT DISTURBANCE (Extreme difficulty walking), VACCINATION COMPLICATION (Reaction to Moderna Covid booster) and BLOOD PRESSURE INCREASED (Blood pressure 165/90) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: abnormal (High) 165/90 mm Hg.         The patient reported that he received the Moderna COVID booster approximately 2 1/2 weeks ago, Two weeks ago the patients wife called ambulance and was admitted to hospital, blood work was performed and all are with in normal limits, patient reports that reactions occur due to booster dose. Patient was discharged from hospital to rehabilitation one week ago and was receiving daily physical and occupational therapy, also to be discharged from rehabilitation on 05-DEC-2021. At the time of this report, therapy with korlyum had ongoing, the therapy dates include 12-OCT-2019 to 24-OCT-2019 dose (300 mg oral, qd), 25-OCT-2019 to unknown date of 2021, again started on 02-SEP-2021 dose (600 mg oral qd). Company comment: This spontaneous case concerning a 78-year-old, male patient with  a history of Hypertension, , Cushing's syndrome , Chronic kidney disease and hyperlipidemia, who experienced the  unexpected serious  events  of fatigue, asthenia, gait disturbance, vaccination complication and blood pressure increased. The events occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the booster dose of mRNA-1273 vaccine. The concurrent conditions of Hypertension, Cushing's syndrome, Chronic kidney disease and hyperlipidemia, and use of polypharmacy, remain as confounders. The case was assessed as serious due to important medical event and hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerning a 78-year-old, male patient with  a history of Hypertension, , Cushing's syndrome , Chronic kidney disease and hyperlipidemia, who experienced the  unexpected serious  events  of fatigue, asthenia, gait disturbance, vaccination complication and blood pressure increased. The events occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the booster dose of mRNA-1273 vaccine. The concurrent conditions of Hypertension, Cushing's syndrome, Chronic kidney disease and hyperlipidemia, and use of polypharmacy, remain as confounders. The case was assessed as serious due to important medical event and hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.