Age: 54.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Sensory disturbance, Sinusitis, Skin bacterial infection, Skin ulcer, Sluggishness
Clinical narrative: sore arm; made her sleep for a couple of days; sluggish; weight gain; Hammer Toe; Vaccination site nodule; Watering eyes; Painful nodule; Eczema; Numbness in face; Bone Disorder; Pain; flu; Sinus infection; facial paresthesia; Neck pain; Back pain; Psoriasis; Skin bacterial infection; Allergic cough; Pollen allergy; Runny nose; Muscular dystrophy; Back arthritis; Shaking; Skin ulcer; Abnormal physical sensation; Vaccination site pain; made her feel tired; Lupus erythematosus; Bell's Palsy; This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus) and BELL'S PALSY (Bell's Palsy) 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.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Psoriatic arthritis, Plaque psoriasis and Rheumatoid arthritis and PREDNISONE for Adverse event.    The patient's past medical history included Flu in December 2020 and Sinus infection in December 2020. Concurrent medical conditions included Pollen allergy, Brain inflammation (INFLAMATION FROM FLUID ON THE BRAIN (Started 1983)) since 1983, Smoker, Abstains from alcohol, Autoimmune disorder, Bell's palsy, Psoriasis (Moderate to severe chronic plaque psoriasis,), Muscular dystrophy, Back arthritis, Hammer toe, Eczema, Psoriatic arthritis, Bone disorder and Rheumatoid arthritis. Concomitant products included DUPILUMAB (DUPIXENT) for Adverse event.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 24-Sep-2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PREDNISONE (unknown route) dosage form. In February 2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (made her sleep for a couple of days), SLUGGISHNESS (sluggish), WEIGHT INCREASED (weight gain), FOOT DEFORMITY (Hammer Toe), VACCINATION SITE NODULE (Vaccination site nodule), LACRIMATION INCREASED (Watering eyes), NODULE (Painful nodule), ECZEMA (Eczema), HYPOAESTHESIA (Numbness in face), BONE DISORDER (Bone Disorder), PAIN (Pain), INFLUENZA (flu), SINUSITIS (Sinus infection), PARAESTHESIA (facial paresthesia), NECK PAIN (Neck pain), BACK PAIN (Back pain), PSORIASIS (Psoriasis), SKIN BACTERIAL INFECTION (Skin bacterial infection), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Pollen allergy), RHINORRHOEA (Runny nose), MUSCULAR DYSTROPHY (Muscular dystrophy), SPONDYLITIS (Back arthritis), TREMOR (Shaking), SKIN ULCER (Skin ulcer), SENSORY DISTURBANCE (Abnormal physical sensation), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (made her feel tired). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus), BELL'S PALSY (Bell's Palsy), FOOT DEFORMITY (Hammer Toe), NODULE (Painful nodule), ECZEMA (Eczema), HYPOAESTHESIA (Numbness in face), BONE DISORDER (Bone Disorder), PAIN (Pain), PARAESTHESIA (facial paresthesia), NECK PAIN (Neck pain), BACK PAIN (Back pain), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Pollen allergy), RHINORRHOEA (Runny nose), MUSCULAR DYSTROPHY (Muscular dystrophy), SPONDYLITIS (Back arthritis), TREMOR (Shaking), SKIN ULCER (Skin ulcer) and SENSORY DISTURBANCE (Abnormal physical sensation) had not resolved, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (made her sleep for a couple of days), SLUGGISHNESS (sluggish), VACCINATION SITE NODULE (Vaccination site nodule), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (made her feel tired) had resolved, WEIGHT INCREASED (weight gain) outcome was unknown and LACRIMATION INCREASED (Watering eyes), INFLUENZA (flu), SINUSITIS (Sinus infection), PSORIASIS (Psoriasis) and SKIN BACTERIAL INFECTION (Skin bacterial infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: lupus (abnormal) Lupus. On an unknown date, Weight: weight increased (High) Weight increased. On an unknown date, X-ray: lupus (abnormal) Lupus.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported included "slicycity sugar shot" and an unspecified antibiotic.  The patient could not stand being in the air conditioning all the time because she was shaking. She gets sores on her head. It dried out her  scalp so she breaks out with Eczema around the ears top of the crown back and around her neckline. It itched and burned. Sometimes felt like something was crawled on her. On 28 Jun 2021, she felt very tired. Her dog woke her up at 5.30 AM and she was unable to go back to sleep. Patient agreed to have physician contacted.  No treatment information was reported.  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. Some individuals  develop autoimmune diseases following vaccines such as Lupus erythematosus. Vaccination site pain and fatigue are consistent with the product known safety profile   This case was linked to US-MODERNATX, INC.-MOD-2021-104950 (E2B Linked Report). This case was linked to MOD-2021-104950 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09 JUL 2021 included Additional adverse events were added- Shaking, Skin Ulcer, Tiredness and Abnormal physical sensation.; 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. Some individuals  develop autoimmune diseases following vaccines such as Lupus erythematosus. Vaccination site pain and fatigue are consistent with the product known safety profile. US-MODERNATX, INC.-MOD-2021-104950:Same patient, 1st dose