Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Subacute cutaneous lupus erythematosus
Clinical narrative: Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization; Four days after vaccination, she noticed worsening of SCLE lesions, characterized by increased pruritis, burning and erythema.; This literature-non-study case was reported in a literature article and describes the occurrence of SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included Subacute cutaneous lupus erythematosus (autoimmune skin diseases may worsen after COVID-19 vaccination). Concurrent medical conditions included Rash (Patient presented with 9 months of a rash on her face, neck, trunk and extremities consistent with SCLE, based on clinicopathological correlation). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Four days after vaccination, she noticed worsening of SCLE lesions, characterized by increased pruritis, burning and erythema.). The patient was treated with MYCOPHENOLATE MOFETIL for Subacute cutaneous lupus erythematosus, at a dose of 500 milligram twice a day; MYCOPHENOLATE MOFETIL for Subacute cutaneous lupus erythematosus, at a dose of 1000 milligram twice a day; MYCOPHENOLATE MOFETIL for Subacute cutaneous lupus erythematosus, at a dose of 1500 milligram twice a day and TRIAMCINOLONE for Subacute cutaneous lupus erythematosus, at an unspecified dose and frequency. At the time of the report, SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization) and CONDITION AGGRAVATED (Four days after vaccination, she noticed worsening of SCLE lesions, characterized by increased pruritis, burning and erythema.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: positive (Positive) Positive and negative (Negative) Negative. On an unknown date, Blood test: positive (Positive) for COVID-19, indicating immunity against COVID-19.. On an unknown date, Double stranded DNA antibody: positive (Positive) Positive. On an unknown date, Skin test: annular erythematous plaques revealed annular erythematous plaques coalescing into polycyclic plaques with raised borders and scaling on the neck, chest, abdomen, back, arms, legs, lateral cheeks and forehead and worsening lesions on her face, neck, After first dose skin examination 1 week after immunization revealed worsening lesions on her face, neck, chest, back and arms.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization) and CONDITION AGGRAVATED (Four days after vaccination, she noticed worsening of SCLE lesions, characterized by increased pruritis, burning and erythema.) to be possibly related.    Months after immunization the patient reported having a positive T cell test for COVID-19, indicating immunity against COVID-19. Also, the patient underwent wet wrap therapy twice a day along with triamcinolone 0.1% ointment treatment.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However,  medical history of Subacute cutaneous lupus erythematosus may remain as confounding factor.   This case was linked to MOD-2021-317843 (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 event, a causal relationship cannot be excluded. However,  medical history of Subacute cutaneous lupus erythematosus may remain as confounding factor.