Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatomyositis, Enteritis infectious, Hypertension, Inappropriate schedule of product administration, Interstitial lung disease
Clinical narrative: dermatologist determined I had discoid lupus based on the biopsy, got my first skin lesion and started having swelling in my hand and wrists; anti-MDA5 DM, got my first skin lesion, experiencing severe throat pain, mouth sores and couldn't swallow, rash on my arms and chest and having swelling in my hand and wrists, as well as joint pain in my knees; I have Interstitial Lung Disease; I messed up the lining of my small intestine with all of the ibuprofen I took for the past year and a half; I started having swelling in my hand and wrists, as well as joint pain in my knees; I had severe carpal tunnel; experience severe joint pain and muscle weakness; She gave me a cream that turned my skin black; Severe flare, mouth sores and rash; hypertension; Gradual weight loss; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC CUTANEOUS LUPUS ERYTHEMATOSUS (dermatologist determined I had discoid lupus based on the biopsy, got my first skin lesion and started having swelling in my hand and wrists), DERMATOMYOSITIS (anti-MDA5 DM, got my first skin lesion, experiencing severe throat pain, mouth sores and couldn't swallow, rash on my arms and chest and having swelling in my hand and wrists, as well as joint pain in my knees), INTERSTITIAL LUNG DISEASE (I have Interstitial Lung Disease) and ENTERITIS INFECTIOUS (I messed up the lining of my small intestine with all of the ibuprofen I took for the past year and a half) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    The patient's past medical history included Hysterectomy. Concurrent medical conditions included Non-smoker (Never smoked). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 15-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHRONIC CUTANEOUS LUPUS ERYTHEMATOSUS (dermatologist determined I had discoid lupus based on the biopsy, got my first skin lesion and started having swelling in my hand and wrists) (seriousness criterion medically significant), DERMATOMYOSITIS (anti-MDA5 DM, got my first skin lesion, experiencing severe throat pain, mouth sores and couldn't swallow, rash on my arms and chest and having swelling in my hand and wrists, as well as joint pain in my knees) (seriousness criterion medically significant), INTERSTITIAL LUNG DISEASE (I have Interstitial Lung Disease) (seriousness criterion medically significant), ENTERITIS INFECTIOUS (I messed up the lining of my small intestine with all of the ibuprofen I took for the past year and a half) (seriousness criterion medically significant), SWELLING (I started having swelling in my hand and wrists, as well as joint pain in my knees), CARPAL TUNNEL SYNDROME (I had severe carpal tunnel), MUSCULAR WEAKNESS (experience severe joint pain and muscle weakness), SKIN DISCOLOURATION (She gave me a cream that turned my skin black), CONDITION AGGRAVATED (Severe flare, mouth sores and rash), HYPERTENSION (hypertension), WEIGHT DECREASED (Gradual weight loss) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). The patient was treated with PREDNISONE at a dose of 60 milligram; PREDNISONE at a dose of 40 milligram; PREDNISONE at a dose of 30 milligram; PREDNISONE at a dose of 20 milligram; PREDNISONE at a dose of Until the bottle is done; MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) at a dose of graduated up in 3 days increments; SULFAMETHOXAZOLE, TRIMETHOPRIM (BETRIM) ongoing since an unknown date at a dose of UNK, 3 times/wk and CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, CHRONIC CUTANEOUS LUPUS ERYTHEMATOSUS (dermatologist determined I had discoid lupus based on the biopsy, got my first skin lesion and started having swelling in my hand and wrists), DERMATOMYOSITIS (anti-MDA5 DM, got my first skin lesion, experiencing severe throat pain, mouth sores and couldn't swallow, rash on my arms and chest and having swelling in my hand and wrists, as well as joint pain in my knees), INTERSTITIAL LUNG DISEASE (I have Interstitial Lung Disease), ENTERITIS INFECTIOUS (I messed up the lining of my small intestine with all of the ibuprofen I took for the past year and a half), SWELLING (I started having swelling in my hand and wrists, as well as joint pain in my knees), CARPAL TUNNEL SYNDROME (I had severe carpal tunnel), MUSCULAR WEAKNESS (experience severe joint pain and muscle weakness), SKIN DISCOLOURATION (She gave me a cream that turned my skin black) and CONDITION AGGRAVATED (Severe flare, mouth sores and rash) had not resolved and HYPERTENSION (hypertension), WEIGHT DECREASED (Gradual weight loss) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2022, Biopsy skin: discoid lupus. On 15-Jun-2023, Computerised tomogram: Interstitial Lung Disease. On an unknown date, Oxygen saturation: 83 % Dropped to 83 % after 2 minutes. On an unknown date, Pulmonary function test: 40 %.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No history of lung disease in the family. The patient never drank. The patient was an athlete all life, se eat fairly well, and favorite beverage was water. She was diagnosed on 29-Jun-2023.   On an unknown date in Apr-2021, the patient received first COVID shot of mRNA-1273. On an unknown date in May-2021, the patient received second COVID shot. On an unknown date in Jun-2021, the patient got first skin lesion. She thought it might be poison ivy, so she began treating it with OTC stuff. In Aug-2021 she went to GP because she had a rash on arms and chest. GP gave a cream that turned patient's skin black. Patient started having swelling in hand and wrists, as well as joint pain in knees. She went to an orthopedic specialist. He determined through an EMG that she had severe carpal tunnel and needed to have surgery on both wrists. Patient also started physical therapy before the surgery and did it for 4 months, but nothing was getting better. In Oct-2021, she had surgery on wrists, in Nov-2021 she experienced severe joint pain and muscle weakness. She could not even get up from a chair. In Dec-2021, she went back to the doctors for her infection, and she finally referred patient to a dermatologist. She also was experiencing severe throat pain, mouth sores and could not swallow. She began self-treating herself with lots and lots of ibuprofen. In Dec-2021 she had extreme joint pain, extreme sore throat, and could not eat. She dropped 40 lbs In January 2022 she saw the dermatologist and did a biopsy on skin. In February 2022 - dermatologist determined discoid lupus based on the biopsy. She started me on two months of hydroxychloroquine. However, when they did the blood test for lupus it came back negative. Now she had down 70 lbs. In April 2022 she still does not know what was wrong but still determined to find out. She was still assuming that she had lupus.; Sender's Comments: This spontaneous case concerns a 56 year-old female patient with medical history of Co-suspect product IBUPROFEN, Hysterectomy and Concomitant products included HYDROXYCHLOROQUINE who experienced the unexpected seriousness criteria medically significant events of chronic cutaneous lupus erythematosus, Dermatomyositis, interstitial lung disease, enteritis infectious; the unexpected events of carpal tunnel syndrome, muscle weakness, skin discoloration, condition aggravated, hypertension and weight loss in the context of 2nd. dose of mRNA-1273 vaccine. As the SD information, there were more than 35 days between first two doses, then Inappropriate schedule of vaccine administration was noted in this case. On 15-Feb-2022 a Biopsy skin diagnosticated discoid lupus and on 15-Jun-2023, CAT scan Interstitial Lung Disease and in unknow day anti-MDA5 DM was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.