Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Renal failure, Skin haemorrhage
Clinical narrative: Had blood work that showed kidney failure; Patient had COVID; Itching; Skin was bleeding and secreting pus; Skin was bleeding and secreting pus; Severe rash all over her body which started on her leg / rash was because of the kidney, it was all over her system; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Had blood work that showed kidney failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced RENAL FAILURE (Had blood work that showed kidney failure) (seriousness criteria hospitalization and medically significant), PRURITUS (Itching), SKIN HAEMORRHAGE (Skin was bleeding and secreting pus), PUSTULE (Skin was bleeding and secreting pus) and RASH (Severe rash all over her body which started on her leg / rash was because of the kidney, it was all over her system). On 12-Oct-2021, the patient experienced COVID-19 (Patient had COVID). The patient was hospitalized for 7 days due to RENAL FAILURE. The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, RENAL FAILURE (Had blood work that showed kidney failure), PRURITUS (Itching), SKIN HAEMORRHAGE (Skin was bleeding and secreting pus), PUSTULE (Skin was bleeding and secreting pus), COVID-19 (Patient had COVID) and RASH (Severe rash all over her body which started on her leg / rash was because of the kidney, it was all over her system) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Biopsy: results not provided (Inconclusive) Results not provided. In June 2021, Blood test: abnormal (abnormal) Had blood work that showed kidney failure.         No medical history information was provided.  Treatment information included summer antibiotics with the use of 4 doses of different antibiotics and creams for the itching and rash but reported that nothing was working.  The patient stayed in hospital for a week as the rash was because of kidney and it was all over her system. The patient experienced rash that started on her feet and was more prominent. She had pictures of the rash, biopsies and stated that the only difference was getting the shot. She was also afraid of getting the booster.  Company comment:This spontaneous case concerning 62 years female patient, experiencing  unexpected serious event of kidney failure (Hospitalization), unexpected non serious AESI event of COVID 19  and unexpected non serious events of Pruritus ,Skin hemorrhage, and pustule .The event COVID 19 occurred after 5 months 21 days after the first dose of mRNA 1273 and outcome was unknown .The events of kidney failure, pruritus ,skin hemorrhage and pustule occurred from unknown date in June 2021, which  required hospitalization and outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerning 62 years female patient, experiencing  unexpected serious event of kidney failure (Hospitalization), unexpected non serious AESI event of COVID 19  and unexpected non serious events of Pruritus ,Skin hemorrhage, and pustule .The event COVID 19 occurred after 5 months 21 days after the first dose of mRNA 1273 and outcome was unknown .The events of kidney failure, pruritus ,skin hemorrhage and pustule occurred from unknown date in June 2021, which  required hospitalization and outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.