Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Full blood count, Full blood count abnormal, Haematuria, Rash
Clinical narrative: A week later, went into kidney failure; blood count dropped down to a 4; Atrocious rash all over legs, all over ankles, up through torso, atrocious rash disappeared and came back again, Rash has not fully gone away; Two weeks later, brother started to urinate blood bad; rash looked like Bechet syndrome flared up; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (A week later, went into kidney failure) and HAEMATURIA (Two weeks later, brother started to urinate blood bad) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asymptomatic COVID-19 (Asymptomatic COVID twice and vaccinated.) in April 2020, Asymptomatic COVID-19 (Asymptomatic COVID twice and vaccinated.) in April 2021 and Neutropenia. Concurrent medical conditions included Drug allergy (extremely sensitive to medications.), Soy allergy (soy sauce.), Behcet syndrome (Bechet syndrome (autoimmune)), Legal blindness, as defined in (legally blind), Kidney failure, Rheumatoid arthritis (rheumatory arthritis), Microcephaly and Learning disorder (non-verbal). Concomitant products included ADALIMUMAB (HUMIRA) for Autoimmune disorder NOS, METRONIDAZOLE (METRO [METRONIDAZOLE]) for an unknown indication.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HAEMATURIA (Two weeks later, brother started to urinate blood bad) (seriousness criterion medically significant), CONDITION AGGRAVATED (rash looked like Bechet syndrome flared up) and RASH (Atrocious rash all over legs, all over ankles, up through torso, atrocious rash disappeared and came back again, Rash has not fully gone away). In January 2022, the patient experienced RENAL FAILURE (A week later, went into kidney failure) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FULL BLOOD COUNT ABNORMAL (blood count dropped down to a 4). The patient was hospitalized on sometime in January 2022 due to RENAL FAILURE. The patient was treated with CIPROFLOXACIN in December 2021 at a dose of UNK (7 day course). At the time of the report, RENAL FAILURE (A week later, went into kidney failure), HAEMATURIA (Two weeks later, brother started to urinate blood bad), CONDITION AGGRAVATED (rash looked like Bechet syndrome flared up) and FULL BLOOD COUNT ABNORMAL (blood count dropped down to a 4) outcome was unknown and RASH (Atrocious rash all over legs, all over ankles, up through torso, atrocious rash disappeared and came back again, Rash has not fully gone away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) positive for COVID asymptomatic. In April 2021, SARS-CoV-2 test: positive (Positive) possibly positive for COVID asymptomatic. In December 2021, Full blood count: 4 (Low) blood count dropped down to a 4.         Company Comment: This is a Spontaneous case concerning a 46-year-old male patient, with reported medical history of Neutropenia, Behcet syndrome, Kidney failure, Drug allergy, Food allergy and Rheumatoid arthritis among others, treated with HUMIRA, who experienced the serious unexpected adverse events of Renal Failure that leads to Hospitalization and Haematuria (Serious criteria Medically Significant for both events). Additionally, other non-serious adverse events were reported in this case as Blood count abnormal. The event of Renal Failure occurred approximately the next month after the administration of the 3rd dose of the mRNA-1273 vaccine; the event of Haematuria occurred approximately two weeks after the administration of the Booster dose of the mRNA-1273 vaccine. Two weeks later the administration of the booster dose, the patient was treated with Ciprofloxacin for 7 days with no diagnostic of UTI. A month after the administration of the booster dose the blood count decrease and, a few days later, was admitted to the hospital with the diagnostic of Renal Failure and receive a blood transfusion. The reported medical history remains as a confounder for the serious and non-serious adverse detailed in this case and the concomitant use of Humira remains as a contributor for the event of Blood count abnormal. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious.   This case was linked to MOD-2022-523201 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 46-year-old male patient, with reported medical history of Neutropenia, Behcet syndrome, Kidney failure, Drug allergy, Food allergy and Rheumatoid arthritis among others, treated with HUMIRA, who experienced the serious unexpected adverse events of Renal Failure that leads to Hospitalization and Haematuria (Serious criteria Medically Significant for both events). Additionally, other non-serious adverse events were reported in this case as Blood count abnormal. The event of Renal Failure occurred approximately the next month after the administration of the 3rd dose of the mRNA-1273 vaccine; the event of Haematuria occurred approximately two weeks after the administration of the Booster dose of the mRNA-1273 vaccine. Two weeks later the administration of the booster dose, the patient was treated with Ciprofloxacin for 7 days with no diagnostic of UTI. A month after the administration of the booster dose the blood count decrease and, a few days later, was admitted to the hospital with the diagnostic of Renal Failure and receive a blood transfusion. The reported medical history remains as a confounder for the serious and non-serious adverse detailed in this case and the concomitant use of Humira remains as a contributor for the event of Blood count abnormal. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious.