Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Ultrasound abdomen, Ultrasound kidney, Urine protein/creatinine ratio, Weight
Clinical narrative: CKD II/III; fatigue; nauseated; drug induceed tremors; anxious; can't eat; Knee bothering; Shaky; Achy all over; Low grade temprature; SIADH; This spontaneous case was reported by a physician and describes the occurrence of CHRONIC KIDNEY DISEASE (CKD II/III) and INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products OXYBATE SODIUM (XYREM) for an unknown indication, MODAFINIL for an unknown indication, SOLRIAMFETOL HYDROCHLORIDE (SUNOSI) for an unknown indication and L-METHYLFOLATE for an unknown indication.    The patient's past medical history included Sleep driving (falling asleep while driving) in April 2018, Weight gain in April 2018, Tiredness in April 2018, Anxiety (disabling) in April 2018, Stress (stressed) in April 2018, Non-traumatic rupture of patellar tendon (knee replacement in Aug 2018) from April 2018 to August 2018, Pain in August 2018, Nausea in August 2018, Knee swelling (using walking due to unstable knee) in August 2018, Fractured toe (fractured big toe) in July 2019, Leg edema in January 2019, Back pain (Hurts her back) in January 2019, COVID-19 (COVID-19 positive) in March 2020, Gallstones in September 2020, Chest pain in September 2020, Daytime sleepiness (sleeping in day) in September 2020, Rotator cuff tear in September 2020, Hyponatremia (recurrent hyponatremia lead to hospitalization when taking antidepressant medications) from 2013 to December 2014, Diastolic heart failure, Endometrial ablation, Arthroscopic surgery (Arthroscopic surgery Right knee), Knee replacement (Right knee replacement) in April 2018, Rotator cuff repair on 08-Sep-2020 and Sodium replacement. Previously administered products included for Product used for unknown indication: armodafinil in July 2019, Effexor, venlafaxine, Desvenlafaxine, xyrem and clonazepam. Past adverse reactions to the above products included Hyponatremia with Desvenlafaxine and venlafaxine; and No adverse event with Effexor, armodafinil, clonazepam and xyrem. Family history included Hypertension (involving her mother, deceased) since an unknown date, Cancer (cancer involving her father (Deceased at the age of 63) and mother. Deceased), Alzheimer's disease (Mother Deceased at the age of 88), Alcohol use (Brother) and CVA (Grandmother). Concurrent medical conditions included Shortness of breath (She was hospitalized as she had short of breath..) since April 2018, Narcolepsy, Hypothyroidism (off thyroid pills), Obstructive sleep apnea syndrome, ADHD, Hiatal hernia, Depression (severe), Genetic polymorphism (Polymorphism in the MTHFR gene On L-methylfolate), Pernicious anemia (On vitamin B12), COPD and GERD. Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) from 26-Mar-2016 to 15-Feb-2023 for Antidepressant therapy, FUROSEMIDE (LASIX [FUROSEMIDE]) for Hypertension, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Pernicious anemia, SODIUM CHLORIDE (SALT) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, OXYBATE SODIUM (XYREM) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, OXYBATE SODIUM (XYREM) (unknown route) Dose reduced, MODAFINIL (unknown route) at an unspecified dose On an unknown date, MODAFINIL (unknown route) dosage was changed to Dose reduced., SOLRIAMFETOL HYDROCHLORIDE (SUNOSI) (unknown route) at an unspecified dose and L-METHYLFOLATE (unknown route) at an unspecified dose. In February 2021, the patient experienced NERVOUSNESS (Shaky), PAIN (Achy all over) and PYREXIA (Low grade temprature). In May 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Knee bothering). In October 2021, the patient experienced TREMOR (drug induceed tremors), ANXIETY DISORDER (anxious), FEEDING DISORDER (can't eat), FATIGUE (fatigue) and NAUSEA (nauseated). On an unknown date, the patient experienced CHRONIC KIDNEY DISEASE (CKD II/III) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH) (seriousness criterion medically significant). At the time of the report, CHRONIC KIDNEY DISEASE (CKD II/III), MUSCULOSKELETAL DISCOMFORT (Knee bothering), TREMOR (drug induceed tremors), ANXIETY DISORDER (anxious), FEEDING DISORDER (can't eat), FATIGUE (fatigue) and NAUSEA (nauseated) was resolving, INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH) outcome was unknown and NERVOUSNESS (Shaky), PAIN (Achy all over) and PYREXIA (Low grade temprature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Magnetic resonance imaging heart: AORTA 1.4 * 1.7 cm  Atherosclerosis was none. In September 2020, Ultrasound abdomen: 1. Cholelithiasis without evidence of cholecystitis.  2. Redemonstrated hepatic 5.8 cm hemangioma.. On 02-Jun-2021, Blood pressure measurement: 134/72. On 02-Jun-2021, Heart rate: 72. On 07-Oct-2021, Blood albumin: 4.4 g/dL at 12:19. On 07-Oct-2021, Blood calcium: 9.1 mg/dl at 12:19. On 07-Oct-2021, Blood chloride: 97 mEq/L at 12:19. On 07-Oct-2021, Blood creatinine: 0.95 mg/dl at 12:19. On 07-Oct-2021, Blood glucose: 92 mg/dl at 12:19. On 07-Oct-2021, Blood phosphorus: 3.5 mg/dl at 12:19. On 07-Oct-2021, Blood potassium: 3.8 mEq/L at 12:19. On 07-Oct-2021, Blood sodium: 138 138 mEq/L at 12:19. On 07-Oct-2021, Blood urea: 21 mg/dl at 12:19. On 07-Oct-2021, Carbon dioxide: 23 23 mEq/L at 12:19. On 12-Oct-2021, Blood pressure measurement: 160/90. On 12-Oct-2021, Heart rate: 70. In October 2021, Weight: lost significant weight. On 07-Apr-2022, Blood albumin: 4.4 g/dL at 10:55. On 07-Apr-2022, Blood calcium: 9.4 mg/dl at 10:55. On 07-Apr-2022, Blood chloride: 99 mEq/L at 10:55. On 07-Apr-2022, Blood creatinine: 0.87 mg/dl at 10:55. On 07-Apr-2022, Blood glucose: 115 mg/dl at 10:55. On 07-Apr-2022, Blood phosphorus: 3.8 mg/dl at 10:55. On 07-Apr-2022, Blood potassium: 4.1 mEq/L at 10:55. On 07-Apr-2022, Blood sodium: 136 136 mEq/L at 10:55. On 07-Apr-2022, Blood urea: 11 mg/dl at 10:55. On 07-Apr-2022, Carbon dioxide: 19 19 mEq/L at 10:55. On 07-Apr-2022, Protein urine: 14.5 mg/dl at 10:55. On 07-Apr-2022, Urine protein/creatinine ratio: 0.14. On 14-Apr-2022, Blood albumin: 4.2 g/dL at 15:08. On 14-Apr-2022, Blood calcium: 8.8 mg/dl at 15:08. On 14-Apr-2022, Blood chloride: 93 mEq/L at 15:08. On 14-Apr-2022, Blood creatinine: 0.89 mg/dl at 15:08. On 14-Apr-2022, Blood glucose: 89 mg/dl at 15:08. On 14-Apr-2022, Blood phosphorus: 3.8 mg/dl at 15:08. On 14-Apr-2022, Blood potassium: 4.3 mEq/L at 15:08. On 14-Apr-2022, Blood pressure measurement: 115/65. On 14-Apr-2022, Blood sodium: 133 133 mEq/L at 15:08. On 14-Apr-2022, Blood urea: 13 mg/dl at 15:08. On 14-Apr-2022, Carbon dioxide: 29 29 mEq/L at 15:08. On 14-Apr-2022, Heart rate: 53. On 15-Sep-2022, Blood albumin: 4.2 g/dL at 07:36. On 15-Sep-2022, Blood calcium: 9.3 mg/dl at 07:36. On 15-Sep-2022, Blood chloride: 100 mEq/L at 07:36. On 15-Sep-2022, Blood creatinine: 0.82 mg/dl at 07:36. On 15-Sep-2022, Blood glucose: 71 mg/dl at 07:36. On 15-Sep-2022, Blood phosphorus: 4.4 mg/dl at 07:36. On 15-Sep-2022, Blood potassium: 4.6 mEq/L at 07:36. On 15-Sep-2022, Blood sodium: 136 136 mEq/L at 07:36. On 15-Sep-2022, Blood urea: 16 mg/dl at 07:36. On 15-Sep-2022, Carbon dioxide: 27 27 mEq/L at 07:36. On 15-Sep-2022, Protein urine: 8.5 mg/dl at 07:36. On 15-Sep-2022, Urine protein/creatinine ratio: 0.15. On 22-Sep-2022, Blood pressure measurement: 124/76. On 22-Sep-2022, Heart rate: 76. On 03-Mar-2023, Blood albumin: 4.4 g/dL at 09:43. On 03-Mar-2023, Blood calcium: 9.2 mg/dl at 09:43. On 03-Mar-2023, Blood chloride: 101 mEq/L at 09:43. On 03-Mar-2023, Blood creatinine: 0.87 mg/dl at 09:43. On 03-Mar-2023, Blood glucose: 86 mg/dl at 09:43. On 03-Mar-2023, Blood phosphorus: 4.0 mg/dl at 09:43. On 03-Mar-2023, Blood potassium: 4.5 mEq/L at 09:43. On 03-Mar-2023, Blood sodium: 138 138 mEq/L at 09:43. On 03-Mar-2023, Blood urea: 20 mg/dl at 09:43. On 03-Mar-2023, Carbon dioxide: 26 26 mEq/L at 09:43. On 03-Mar-2023, Protein urine: 4.4 mg/dl at 09:43. On 03-Mar-2023, Urine protein/creatinine ratio: 0.14. On 09-Mar-2023, Blood pressure measurement: 126/76. On 09-Mar-2023, Heart rate: 53. On an unknown date, Blood creatinine: 0.7-1 mg/dL (in March hospitalization) and 0.8-0.9 mg/dL (latest creatinine). On an unknown date, Blood sodium: dips to low 130s but rarely and mostly normal range. On an unknown date, Physical examination: Gen: awake, not in distress  HEENT: pink conjunctivae, anicteric sclerae  Neck: supple, no JVD  CVS: regular rate and rhythm, no edema  Lungs: clear to auscultation  Abd: soft, non-tender  Ext: Moves all extremities  Neuro: alert, oriented x 3, no focal deficits. On an unknown date, Ultrasound abdomen: both kidney unremarkable without cyst, hydronephrosis or increased echogenicity. On an unknown date, Ultrasound kidney: unremarkable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In Apr 2022, patient was taken off xyrem and she was feeling better. patient was just on clonazepam to help in sleep. Patient had diarrhea recently but thought this was after labs. It got better when patient was doing BRAT Diet but had come back again though not severe. She was taking Naa lg daily. In Jul 2022 and patient had sterna fracture and abdominal wall hematoma. Patient managed conservatively with sterna precautions and abdominal binders. Patient's right shoulder was much better. Patient was feeling better. She still had restrictions with sternal fracture. In Mar 2023 patient was doing much better since last visit. Patient had been doing therapy but felt like right shoulder was not getting stronger. Patient had MRI and found to have rotator cuff tear. No planned surgery. patient was concerned that her pristiq which will be switched to generic because of cost. Patient had hyponatremia with venlafaxine when physician initially seen many years ago which took a long time to control symptoms before getting it right with pristiiq. At this time, the patient was CKD Stage 2/3. SIADH secondary to chronic effexor use - She was initially referred to physician in may 2015 for hyponatremia while on effexor. TSH and cortisol were normal then and she had elevated urine osmolality. She was weaned off of this and was put on multiple medicine. combination - sertraline, wellbutrin and was very anxious and shaky for about a year. She was on fluid restriction/satt tablet and lasix. She was finally transitioned to Pristiq on 26 mar 2016 and had been on this since.  Treatment medications of the patient was not reported.  Company Comment: This spontaneous case reported by a 77 years old female patient, with past medical history of hypertension, who experienced the unexpected serious (medically significant, hospitalization) event of chronic kidney disease and unexpected serious (medically significant) event of Inappropriate antidiuretic hormone secretion, which occurred unspecified days after a first dose of mRNA-1273 vaccination. Patient experienced hyponatremia venlafaxine when physician initially seen many years ago which took a long time to control symptoms before getting it right with pristiiq. TSH, Cortisol was normal and elevated urine osmolality. Patient was on multiple medication for one year, patient was shaky for about a year, was on fluid restriction, satt tablet and Lasix . At this time, the patient was CKD Stage 2/3. SIADH secondary to chronic effexor use.  In Jul 2022 and patient had sterna fracture and abdominal wall hematoma. Blood creatinine is 0.7-1 mg/dL (in March hospitalization) and 0.8-0.9 mg/dL (latest creatinine). Ultrasound abdomen: both kidney unremarkable without cyst, hydronephrosis or increased echogenicity. Past medical history of hypertension is risk factor for the event. At the time of reporting event is recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a 77 years old female patient, with past medical history of hypertension, who experienced the unexpected serious (medically significant, hospitalization) event of chronic kidney disease and unexpected serious (medically significant) event of Inappropriate antidiuretic hormone secretion, which occurred unspecified days after a first dose of mRNA-1273 vaccination. Patient experienced hyponatremia venlafaxine when physician initially seen many years ago which took a long time to control symptoms before getting it right with pristiiq. TSH, Cortisol was normal and elevated urine osmolality. Patient was on multiple medication for one year, patient was shaky for about a year, was on fluid restriction, satt tablet and Lasix . At this time, the patient was CKD Stage 2/3. SIADH secondary to chronic effexor use.  In Jul 2022 and patient had sterna fracture and abdominal wall hematoma. Blood creatinine is 0.7-1 mg/dL (in March hospitalization) and 0.8-0.9 mg/dL (latest creatinine). Ultrasound abdomen: both kidney unremarkable without cyst, hydronephrosis or increased echogenicity. Past medical history of hypertension is risk factor for the event. At the time of reporting event is recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.