Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio decreased, Night sweats, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney; Stage 3 kidney disease; terrible pain in my lower right abdomen; flu like symptoms; diarrhea; night sweats; Fever; vomiting; chills; Red rash; my right arm from shoulder to wrist was swelling; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2DA and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation since 2005, Hypertension (Medically controlled) since 2005, Chronic lymphocytic leukaemia since 2005 and Cholesterol. Concomitant products included WARFARIN from 2005 to an unknown date and ATENOLOL from 2005 to an unknown date for Atrial fibrillation, SIMVASTATIN from 2005 to an unknown date for Cholesterol, DIGOXIN from 2005 to 11-Jun-2021 for Heart failure, LEVOTHYROXINE from 2018 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (my right arm from shoulder to wrist was swelling) and PRURITUS (itchiness). On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), PYREXIA (Fever), VOMITING (vomiting) and CHILLS (chills). On 16-Feb-2021, the patient experienced RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) (seriousness criteria hospitalization and medically significant), CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) (seriousness criterion medically significant) and ABDOMINAL PAIN (terrible pain in my lower right abdomen). The patient was hospitalized from 16-Feb-2021 to 23-Feb-2021 due to RENAL ARTERY THROMBOSIS. The patient was treated with Surgery (Catheter-based thrombectomy) for Renal artery thrombosis. On 23-Feb-2021, RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) had resolved. On 15-May-2021, CHRONIC KIDNEY DISEASE (Stage 3 kidney disease), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), ABDOMINAL PAIN (terrible pain in my lower right abdomen), RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (my right arm from shoulder to wrist was swelling), PRURITUS (itchiness), PYREXIA (Fever), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, International normalised ratio decreased: low (Low) blood INR was 1.4 upon arrival in the emergency room. It had dropped  from 3.0.         Company comment: 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.  Further information is expected.   This case was linked to MOD-2021-012826 (Patient Link).; 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.  Further information is expected.