Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Double stranded DNA antibody, Skin test, Subacute cutaneous lupus erythematosus, Vaccination site pain
Clinical narrative: Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization; pain at the injection site; 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). Previously administered products included for an unreported indication: PREDNISONE. Concurrent medical conditions included Rash (9 months;  extremities consistent with SCLE). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 VACCINATION SITE PAIN (pain at the injection site). 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 a dose of UNK UNK, bid. At the time of the report, SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus (SCLE) flare after COVID-19 immunization) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      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, Double stranded DNA antibody: positive (Positive) Positive. On an unknown date, Skin test: annular erythematous plaques (abnormal) Skin examination 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, chest, back (abnormal) 1 week after immunization worsening lesions on her face, neck, chest, back and arms.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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 VACCINATION SITE PAIN (pain at the injection site) to be possibly related.    Months after immunization the patient reported having a positive T cell test for COVID-19, indicating immunity against COVID-19.  Characterized of SCLE lesions was determined by increased pruritis, burning and erythema. She endorsed pain at the injection site but denied systemic symptoms.  Also, the patient underwent wet wrap therapy twice a day along with triamcinolone 0.1% ointment  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. However, the patient's medical history of subacute cutaneous lupus erythematosus with multiple treatments to control the disease, is a confounder.   This case was linked to MOD-2021-317937 (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. However, the patient's medical history of subacute cutaneous lupus erythematosus with multiple treatments to control the disease, is a confounder.