Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Panic attack, Pruritus, Rash, Rash pruritic
Clinical narrative: her kidney is in the limit of a kidney failure; cannot sleep; it's itching like crazy; anxiety; panic attacks; depression; condition worsened; started breaking out on a rash in different parts of the body; scratched and started having bruises; itched so much; scratched and started having bruises; it was like boils on her body; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (her kidney is in the limit of a kidney failure) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 027CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESTRADIOL, LIOTHYRONINE, AMITRIPTYLINE, FLUOXETINE, GABAPENTIN, PROGESTERONE, SPIRONOLACTONE, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), MONTELUKAST, LEVOTHYROXINE, FLUTICASONE, ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ESSENTIAL OILS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced RASH PRURITIC (itched so much), CONTUSION (scratched and started having bruises), FURUNCLE (it was like boils on her body), SKIN ABRASION (scratched and started having bruises) and RASH (started breaking out on a rash in different parts of the body). On an unknown date, the patient experienced RENAL FAILURE (her kidney is in the limit of a kidney failure) (seriousness criterion medically significant), INSOMNIA (cannot sleep), PRURITUS (it's itching like crazy), ANXIETY (anxiety), PANIC ATTACK (panic attacks), DEPRESSION (depression) and CONDITION AGGRAVATED (condition worsened). At the time of the report, RENAL FAILURE (her kidney is in the limit of a kidney failure), RASH PRURITIC (itched so much), CONTUSION (scratched and started having bruises), FURUNCLE (it was like boils on her body), INSOMNIA (cannot sleep), PRURITUS (it's itching like crazy), ANXIETY (anxiety), PANIC ATTACK (panic attacks), DEPRESSION (depression), SKIN ABRASION (scratched and started having bruises), CONDITION AGGRAVATED (condition worsened) and RASH (started breaking out on a rash in different parts of the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 30 (High) gained 30 pounds.         Patient had been to her doctor, to a dermatologist and to the ER.. Patient was 5 rounds of prednisone and had prednisone shots (that's when she got better but as soon as she stops it, the itching came back and worsened). Said it was freaking miserable.  Patient gained 30 pounds because of being in prednisone and patient in the border of dialysis. patient was never had any of this before the vaccine.  Patient stopped the prednisone because her kidney is in the limit of a kidney failure.  Patient was been in every antihistamine and they were not helping. It was pretty bad.  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 not expected.   This case was linked to MOD-2021-275213 (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 not expected.