Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, C-reactive protein, Complement factor, Complement factor C3, Complement factor C4
Clinical narrative: Subacute cutaneous lupus erythematosus; This literature-non-study case was reported in a literature article and describes the occurrence of SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus erythematosus) in a 79-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       Concurrent medical conditions included Hypothyroidism and Essential thrombocytosis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LOVASTATIN and LEVOTHYROXINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus erythematosus) (seriousness criterion medically significant). The patient was treated with HYDROXYCHLOROQUINE at a dose of 200 milligram twice a day; PREDNISONE at a dose of 5 milligram once a day; MYCOPHENOLATE MOFETIL at a dose of 500 milligram, in addition to HCQ and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) (intravenous) at a dose of UNK UNK, qmo. At the time of the report, SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (Subacute cutaneous lupus erythematosus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aldolase: Less than 11.7 U/mL. normal. On an unknown date, Anti-cyclic citrullinated peptide antibody: Less than 3.0 U/mL (Normal). On an unknown date, Antibody test: (Negative) Myositis antibody panel test was Negative. On an unknown date, Antinuclear antibody: (Negative) ANA and ANA profile were negative, (Negative) la antibodies and (Negative) RO antibodies was Negative. On an unknown date, Biopsy skin: revealed an interface dermatitis with eosinophils, and drug eruption versus photodermatitis was favored at that time (Biopsy taken from right posterior shoulder), revealed superficial perivascular lymphocytic infiltrate and marked increase in dermal mucin, consistent with subacute cutaneous lupus erythematosus (SCLE) or systemic LE or dermatomyositis (DM) (Second biopsy taken from the right upper back) and revealed interface changes and superficial and mid dermal perivascular dermatitis with increased interstitial mucin consistent with subacute cutaneous lupus erythematosus (SCLE) or dermatomyositis (DM) (third biopsy taken from the left posterior shoulder and mid back). On an unknown date, Blood creatine phosphokinase (35-232 U/L): 25 U/L normal. On an unknown date, C-reactive protein: less than 1.0 mg/dl. On an unknown date, Complement factor (Unknown-41 enzyme unit per millilitre): 41 enzyme unit per millilitre mildly low total. On an unknown date, Complement factor C3 (85.0-180.0 mg/dl): 117.2 mg/dl normal. On an unknown date, Complement factor C4 (14.0-52.0 mg/dl): 12.4 mg/dl mildly low. On an unknown date, Computerised tomogram abdomen: not concerning for malignancy or paraneoplastic process. On an unknown date, Computerised tomogram pelvis: not concerning for malignancy or paraneoplastic process. On an unknown date, Computerised tomogram thorax: not concerning for malignancy or paraneoplastic process. On an unknown date, Full blood count: Normal. On an unknown date, Immunology test: Negative. On an unknown date, Physical examination: revealed diffuse scalp erythema and scaly erythematous, annular plaques with raised borders on the back, chest, breasts, abdomen, and shoulders. The bilateral fingernails were ridged with no noted ragged cuticles, periungual erythema, or dorsal hand erythema. On an unknown date, Protein total: Serum Chemistry was normal. On an unknown date, Red blood cell sedimentation rate: less than 40 mm/hr (Normal). On an unknown date, Rheumatoid factor (0-15 international unit per millilitre): 42 international unit per millilitre.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient presented to the dermatologist due to the acute onset of a widespread, pruritic exanthem, to the upper and lower back, chest, breasts, abdomen, and shoulders. The patient reported no notable triggers, denied recent infection, ultraviolet (UV) radiation, or new drug intake. The patient denied muscle weakness, history of psychosis, headaches, seizures, malar rash, oral ulcers, chest pain, shortness of breath, or dysphagia. The patient reported that the event started approximately two weeks after second dose of the mRNA-based SARS-CoV-2 vaccination (Moderna).  The rash did not improve with topical corticosteroids; therefore, after the second biopsy, the patient was then prescribed  with hydroxychloroquine (HCQ) 200mg BID and prednisone 5 mg daily. Persistent rash, no change in pruritus, and prednisone intolerance necessitated the addition of mycophenolate mofetil (MMF) 500mg BID in addition to HCQ. The rash and pruritus persisted. After a third skin biopsy, which confirmed findings consistent with SCLE or DM, MMF was stopped; monthly intravenous immunoglobulin (IVIG) therapy was initiated in addition to HCQ and topical corticosteroids (unspecified). The patient reported rash resolution with nine monthly infusions of IVIG, HCQ, and topical corticosteroids.  Author concluded development of SCLE was known to be induced by environmental factors such as UV light, malignancy, drugs, and vaccines. Vaccinations can induce or exacerbate inflammatory and auto-immune disease, albeit at low incidence. mRNA vaccines elicit immunity to SARS-CoV-2 via the production of spike protein and IFNs. This report underscores the propensity for vaccination to induce or exacerbate SCLE or immune mediated type skin reactions and emphasize the Th1 cell-mediated immune side of SCLE pathogenesis to emphasize that various arms of SCLE pathophysiology can become perturbed with vaccination, resulting in the in the lack of common laboratory findings associated with SCLE.  Company comment: This is a literature non-study case concerning a 79-year-old female patient with a history of Hypothyroidism and Essential thrombocytosis, who experienced the serious (due to medically significant) unexpected, event of Subacute cutaneous lupus erythematosus (SCLE). The event occurred approximately 2 weeks after the second dose of mRNA-1273 vaccine administration. The patient presented with acute onset of a widespread, pruritic exanthem to the upper and lower back, chest, breasts, abdomen, and shoulders. No notable triggers or concomitant symptoms were reported. Examination was significant for diffuse scalp erythema and scaly erythematous, annular plaques with raised borders on the back, chest, breasts, abdomen, and shoulders. The bilateral fingernails were ridged with no noted ragged cuticles, periungual erythema, or dorsal hand erythema. A Skin biopsy taken from the patient's right posterior shoulder revealed an interface dermatitis with eosinophils, and drug eruption versus photodermatitis was favored at that time. The rash, however, did not improve with application of topical corticosteroids. A second skin biopsy taken from the right upper back revealed superficial perivascular lymphocytic infiltrate and marked increase in dermal mucin, consistent with SCLE or systemic LE or dermatomyositis (DM). Laboratory investigations at that time showed normal blood cell count, serum chemistry, cyclic citrullinated peptide antibody, erythrocyte sedimentation rate and c-reactive protein and elevated rheumatoid factor. ANA and ANA profile were negative, including Ro and La antibodies. Myositis antibody panel was negative, and levels of aldolase and creatine kinase were normal. The patient was found to have mildly low C4, normal C3, and mildly low total complement. CT imaging of the chest, abdomen, and pelvis was not concerning for malignancy or paraneoplastic process. The patient was then prescribed hydroxychloroquine (HCQ) 200mg BID and prednisone 5 mg daily. Persistent rash, no change in pruritus, and prednisone intolerance necessitated the addition of mycophenolate mofetil (MMF) 500mg BID in addition to HCQ. The rash and pruritus persisted. A third skin biopsy of the left posterior shoulder and mid back confirmed findings consistent with SCLE or DM. Direct immunofluorescence studies (DIF) were negative. MMF was stopped; monthly intravenous immunoglobulin (IVIG) therapy was initiated in addition to HCQ 200mg BID and topical corticosteroids. The outcome of the event was reported as recovered after nine monthly infusions. Vaccinations can induce or exacerbate inflammatory and auto-immune disease. As both SCLE and mRNA vaccine effects are IFN-mediated, the potential for SARS CoV-2 vaccination to induce or exacerbate SCLE is possible. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2023: Live follow up received by safety on 09-FEB-2023 has an email with full text article and contains significant information: Literature citation, patient information, medical history, lab data, event information and narrative were updated; Sender's Comments: Company comment: This is a literature non-study case concerning a 79-year-old female patient with a history of Hypothyroidism and Essential thrombocytosis, who experienced the serious (due to medically significant) unexpected, event of Subacute cutaneous lupus erythematosus (SCLE). The event occurred approximately 2 weeks after the second dose of mRNA-1273 vaccine administration. The patient presented with acute onset of a widespread, pruritic exanthem to the upper and lower back, chest, breasts, abdomen, and shoulders. No notable triggers or concomitant symptoms were reported. Examination was significant for diffuse scalp erythema and scaly erythematous, annular plaques with raised borders on the back, chest, breasts, abdomen, and shoulders. The bilateral fingernails were ridged with no noted ragged cuticles, periungual erythema, or dorsal hand erythema. A Skin biopsy taken from the patient's right posterior shoulder revealed an interface dermatitis with eosinophils, and drug eruption versus photodermatitis was favored at that time. The rash, however, did not improve with application of topical corticosteroids. A second skin biopsy taken from the right upper back revealed superficial perivascular lymphocytic infiltrate and marked increase in dermal mucin, consistent with SCLE or systemic LE or dermatomyositis (DM). Laboratory investigations at that time showed normal blood cell count, serum chemistry, cyclic citrullinated peptide antibody, erythrocyte sedimentation rate and c-reactive protein and elevated rheumatoid factor. ANA and ANA profile were negative, including Ro and La antibodies. Myositis antibody panel was negative, and levels of aldolase and creatine kinase were normal. The patient was found to have mildly low C4, normal C3, and mildly low total complement. CT imaging of the chest, abdomen, and pelvis was not concerning for malignancy or paraneoplastic process. The patient was then prescribed hydroxychloroquine (HCQ) 200mg BID and prednisone 5 mg daily. Persistent rash, no change in pruritus, and prednisone intolerance necessitated the addition of mycophenolate mofetil (MMF) 500mg BID in addition to HCQ. The rash and pruritus persisted. A third skin biopsy of the left posterior shoulder and mid back confirmed findings consistent with SCLE or DM. Direct immunofluorescence studies (DIF) were negative. MMF was stopped; monthly intravenous immunoglobulin (IVIG) therapy was initiated in addition to HCQ 200mg BID and topical corticosteroids. The outcome of the event was reported as recovered after nine monthly infusions. Vaccinations can induce or exacerbate inflammatory and auto-immune disease. As both SCLE and mRNA vaccine effects are IFN-mediated, the potential for SARS CoV-2 vaccination to induce or exacerbate SCLE is possible. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.