Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Systemic lupus erythematosus
Clinical narrative: After the vaccine patient Lupus blew up; Sinus bleed; Patient had an allergic reaction; Big black blotch; Rash all over patient bra lines / Rash all over her skin; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (After the vaccine patient Lupus blew up), RASH MACULAR (Big black blotch) and RASH (Rash all over patient bra lines / Rash all over her skin) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 007B21A and 0048A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RASH MACULAR (Big black blotch) (seriousness criterion medically significant) and RASH (Rash all over patient bra lines / Rash all over her skin) (seriousness criterion medically significant). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (After the vaccine patient Lupus blew up) (seriousness criterion medically significant), EPISTAXIS (Sinus bleed) and HYPERSENSITIVITY (Patient had an allergic reaction). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (After the vaccine patient Lupus blew up), EPISTAXIS (Sinus bleed), HYPERSENSITIVITY (Patient had an allergic reaction), RASH MACULAR (Big black blotch) and RASH (Rash all over patient bra lines / Rash all over her skin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: 2 Biopsies was done. The result was Drug related rash. On an unknown date, Blood test: (Negative) blood tests for different skin diseases and all came back negative.         No concomitant medications were reported. Patient visited the rheumatologist regarding the issue and ran some blood tests.She said that she had a lot whole of side effects. No treatment information was provided. Company Comment: This spontaneous case concerns a 71 year old female patient with concurrent medical condition of Systemic Lupus erythematosus , who experienced Serious ( medically significant ) , unexpected events of Systemic Lupus Erythematosus ( after the vaccine patient Lupus blew up ) , Rash and Rash erythematosus . This was accompanied by other non-serious , unexpected event of Epistaxis   and non-serious expected event of hypersensitivity . The events occurred on an unknown date in December post vaccination  with the third dose of mRNA-1273 vaccine. This patient also received two doses of mRNA-1273 as primary dose series of Covid 19 vaccination. The reporter states she had an allergic reaction to the  booster of the Moderna Covid 19 vaccine.One week after vaccination with the third dose of mRNA-1273 vaccine  she developed a big black blotch, after this she developed a rash all over her bra lines,  then the rash was all over her skin. She visited the rheumatologist regarding this issue and they ran some blood tests for different skin diseases and all came back negative. She also underwent  2 biopsies and the result was Drug related rash. She also reported that her Lupus blew up and has sinus bleed after the vaccination . Treatment details were not reported. Outcome of the events was unknown. The concurrent medical condition of Systemic Lupus Erythematosus of this patient may be considered as a confounder for the events. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-659183 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71 year old female patient with concurrent medical condition of Systemic Lupus erythematosus , who experienced Serious ( medically significant ) , unexpected events of Systemic Lupus Erythematosus ( after the vaccine patient Lupus blew up ) , Rash and Rash erythematosus . This was accompanied by other non-serious , unexpected event of Epistaxis   and non-serious expected event of hypersensitivity . The events occurred on an unknown date in December post vaccination  with the third dose of mRNA-1273 vaccine . This patient also received two doses of mRNA-1273 as primary dose series of Covid 19 vaccination. The reporter states she had an allergic reaction to the  booster of the Moderna Covid 19 vaccine.One week after vaccination with the third dose of mRNA-1273 vaccine  she developed a big black blotch, after this she developed a rash all over her bra lines,  then the rash was all over her skin. She visited the rheumatologist regarding this issue and they ran some blood tests for different skin diseases and all came back negative. She also underwent  2 biopsies and the result was Drug related rash. She also reported that her Lupus blew up and has sinus bleed after the vaccination . Treatment details were not reported. Outcome of the events was unknown. The concurrent medical condition of Systemic Lupus Erythematosus of this patient may be considered as a confounder for the events. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.    :