Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: (Patch) nine days later started itching; (Patch) developed a bump; Large, red patch that was very sore; Headache; Slightly Achy/  was very sore/ Ached like I have never ached in my life/ Excruciating Pain; Nauseated; Running a fever of 100.6 degrees; Rigor Chills; Cytokine Reaction; Interstitial Cystitis; UTI; Sick to her stomach; Couldn't eat; Dizzy; Couldn't keep anything down; Inflammation Storm; Very unsteady; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (Cytokine Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second 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 06-Mar-2021, the patient experienced CYTOKINE STORM (Cytokine Reaction) (seriousness criterion medically significant), CYSTITIS INTERSTITIAL (Interstitial Cystitis), URINARY TRACT INFECTION (UTI), ABDOMINAL DISCOMFORT (Sick to her stomach), EATING DISORDER (Couldn't eat), DIZZINESS (Dizzy), MOBILITY DECREASED (Couldn't keep anything down), INFLAMMATION (Inflammation Storm), MALAISE (Very unsteady), HEADACHE (Headache), MYALGIA (Slightly Achy/  was very sore/ Ached like I have never ached in my life/ Excruciating Pain), NAUSEA (Nauseated), PYREXIA (Running a fever of 100.6 degrees) and CHILLS (Rigor Chills). On an unknown date, the patient experienced VACCINATION SITE PRURITUS ((Patch) nine days later started itching), VACCINATION SITE SWELLING ((Patch) developed a bump) and VACCINATION SITE ERYTHEMA (Large, red patch that was very sore). At the time of the report, CYTOKINE STORM (Cytokine Reaction), CYSTITIS INTERSTITIAL (Interstitial Cystitis), URINARY TRACT INFECTION (UTI), ABDOMINAL DISCOMFORT (Sick to her stomach), EATING DISORDER (Couldn't eat), DIZZINESS (Dizzy), MOBILITY DECREASED (Couldn't keep anything down), INFLAMMATION (Inflammation Storm), MALAISE (Very unsteady), VACCINATION SITE PRURITUS ((Patch) nine days later started itching), HEADACHE (Headache), MYALGIA (Slightly Achy/  was very sore/ Ached like I have never ached in my life/ Excruciating Pain), NAUSEA (Nauseated), PYREXIA (Running a fever of 100.6 degrees), CHILLS (Rigor Chills), VACCINATION SITE SWELLING ((Patch) developed a bump) and VACCINATION SITE ERYTHEMA (Large, red patch that was very sore) outcome was unknown.            Concomitant product was not provided by the reporter  Patient reported that after receiving vaccine she experienced rash then it large, red patch that was very sore and bump developed. After 9 days it began to itch. After second dose she experienced cytokine reaction and inflammation storm in her system. and other events from next day.  Treatment information was not provided. 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.; 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.