Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: walls of the blood vessels are bursting and bleeding; leukocytoclastic vasculitis; Body felt hot; Severe skin rash that is bumpy on side of thigh and leg spreading to face; Chills; Slight fever/Body felt hot; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (walls of the blood vessels are bursting and bleeding) and CUTANEOUS VASCULITIS (leukocytoclastic vasculitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040c21a, 031a21a and 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced RASH (Severe skin rash that is bumpy on side of thigh and leg spreading to face), CHILLS (Chills) and PYREXIA (Slight fever/Body felt hot). On an unknown date, the patient experienced HAEMORRHAGE (walls of the blood vessels are bursting and bleeding) (seriousness criterion medically significant), CUTANEOUS VASCULITIS (leukocytoclastic vasculitis) (seriousness criterion medically significant) and FEELING HOT (Body felt hot). At the time of the report, HAEMORRHAGE (walls of the blood vessels are bursting and bleeding), CUTANEOUS VASCULITIS (leukocytoclastic vasculitis), FEELING HOT (Body felt hot), RASH (Severe skin rash that is bumpy on side of thigh and leg spreading to face), CHILLS (Chills) and PYREXIA (Slight fever/Body felt hot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment includes 4 day regimen of 13 prednisone pills total, with decreasing doses severe skin rash on the inside of the left thigh and leg on the day of taking the 3rd booster shot  on 29-Oct-2021. The rash seems to spread to the other side of the body, to the right thigh and leg and her face  Company Comment: This case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected events of erectile hemorrhage and cutaneous vasculitis.  The events occurred on the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event was reported exclusively after the last administered dose.  The reporter did not provide causality relationship with the product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (-medically significant) per regulatory reporting.   This case was linked to MOD-2021-369085, MOD-2021-010081 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant Follow up. Contact info,Events,Treatment medications were added.; Sender's Comments: This case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected events of erectile hemorrhage and cutaneous vasculitis.  The events occurred on the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event was reported exclusively after the last administered dose.  The reporter did not provide causality relationship with the product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (-medically significant) per regulatory reporting.