Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood triglycerides increased, Hypotension, Steal syndrome
Clinical narrative: Low blood pressure after dialysis.; Steal syndrome in left hand/Patient developed complications with dialysis fistula that lead to circulation issues in left hand/no feeling to hand; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Low blood pressure after dialysis.) and STEAL SYNDROME (Steal syndrome in left hand/Patient developed complications with dialysis fistula that lead to circulation issues in left hand/no feeling to hand) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A, 088D21A, 083J21A and 016B22A) for COVID-19 prophylaxis.     The patient's past medical history included Transcatheter aortic valve replacement (aortic valve replacement with a TAVR procedure), Dialysis and Fistula repair in July 2021. Concurrent medical conditions included Immunocompromised, Renal disease (Dialysis), Atrial fibrillation, Coronary artery disease, Hyperlipidemia, Hypertriglyceridemia, Prostate cancer and Diabetes. Concomitant products included METOPROLOL TARTRATE for Atrial fibrillation, ROSUVASTATIN CALCIUM (CRESTOR) for Coronary artery disease and Hypertriglyceridaemia, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) for Diabetes, RANOLAZINE (RANEXA SR), APIXABAN (ELIQUIS), INSULIN LISPRO (HUMALOG), ESOMEPRAZOLE, COLECALCIFEROL (VITAMIN D3), CLOPIDOGREL, CALCITRIOL, SODIUM ZIRCONIUM CYCLOSILICATE (LOKELMA), CINACALCET, LEVOTHYROXINE SODIUM (SYNTHROID), LANTHANUM CARBONATE, METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (MIRCERA), SEVELAMER, FISH OIL, TOCOPHEROL, UBIDECARENONE (COENZYME Q10 PLUS) and INSULIN DETEMIR (LEVEMIR) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced STEAL SYNDROME (Steal syndrome in left hand/Patient developed complications with dialysis fistula that lead to circulation issues in left hand/no feeling to hand) (seriousness criterion medically significant). In May 2022, the patient experienced HYPOTENSION (Low blood pressure after dialysis.) (seriousness criterion hospitalization). At the time of the report, HYPOTENSION (Low blood pressure after dialysis.) and STEAL SYNDROME (Steal syndrome in left hand/Patient developed complications with dialysis fistula that lead to circulation issues in left hand/no feeling to hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood pressure measurement: low blood pressure after dialysis. On an unknown date, Blood triglycerides increased: Increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no Thyroid. In March or April of 2021 the patient developed Steal syndrome in his left hand.The patient has limited use of his left hand. The patient then developed complications with his dialysis fistula that lead to circulation issues in left hand. In July of 2021 the patient had a dialysis fistula repaired. In November of 2021 the patient had the dialysis fistula blocked off with a procedure at the hospital.  No treatment information was reported. Company comment--This spontaneous case concerns an adult male patient of unknown age with relevant medical history of Immunocompromised status, Renal disease (on Dialysis), Atrial fibrillation, Coronary artery disease and Diabetes reported, who experienced the unexpected serious (Hospitalization) event of Hypotension ( reported as Low blood pressure after dialysis), unexpected serious (medically significant) event of Steal syndrome in the context of mRNA-1273 vaccination. Patient had received primary vaccination at an appropriate schedule, third dose after 6 months and fourth dose after 6 months subsequently. It was reported that about 1-2 months after second dose, patient developed Steal syndrome in his left hand with limited use of his left hand. Later developed complications with his dialysis fistula that lead to circulation issues in his left hand. He had a dialysis fistula repaired after 3 months, followed by dialysis fistula blocked off with a procedure at the hospital in the subsequent months. About three months after Dose 4, patient was hospitalized for low blood pressure after dialysis. No further information on detailed clinical course, investigations results, other treatment details was available in the report. Outcome of the events was unknown at the time of report. The relevant medical history remains as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-718140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Live Significant follow up received which contains new events, concomitant medications, patient age group and medical history were added, and Product details were updated.