Age: 54.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Fatigue, Foot deformity, Hypoaesthesia, Influenza, Injection site induration
Clinical narrative: face tingling; neck pain/ hurting really bad and pulling on her neck; back pain/ hurting really bad and pulling on her neck and back; SLUGGISH AFTER SECOND VACCINE; psoriasis; had bacteria on forehead and side of face; coughing from pollen; pollen allergy; sniffling and blowing her nose; muscular dystrophy; arthritis made back stiff; bones hurt really bad; HAMMER TOES/KNOT UNDERNEATH THAT WAS PAINFUL AND IT WAS CURVED; RIGHT EYE POURS WITH WATER; PAIN DUE TO CHANGE OF WEATHER FROM NECK ALL THE WAY DOWN; Painful nodule; ARM SORE WITH LITTLE KNOT FROM COVID SHOT; FIRST COVID VACCINE ARM SORE, SECOND COVID VACCINE ARM SORE; TIRED FROM COVID SHOT; another bell's palsy attack; gain weight; autoimmune disease; HAMMER TOES/KNOT UNDERNEATH THAT WAS PAINFUL AND IT WAS CURVED; SLEEPY FROM COVID SHOT/ SLEPT FOR TWO DAYS; watering eyes; eczema gotten really bad on hands and feet; FACE NUMB AND TINGLING; bone disorder; sore arm; blood showed lupus; BELLE PALSY ATTACK/DUE TO WEATHER; flu; sinus infection; This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (blood showed lupus), BELL'S PALSY (BELLE PALSY ATTACK/DUE TO WEATHER) and CONDITION AGGRAVATED (another bell's palsy attack) 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, Psoriasis and Rheumatoid arthritis and PREDNISONE for an unknown indication.    Concurrent medical conditions included Brain inflammation (inflammation from fluid on the brain.) since 1983, Smoker (One pack a day.) and Abstains from alcohol. Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PREDNISONE (unknown route) dosage form. In December 2000, the patient experienced SINUSITIS (sinus infection). In December 2020, the patient experienced INFLUENZA (flu). In February 2021, the patient experienced BELL'S PALSY (BELLE PALSY ATTACK/DUE TO WEATHER) (seriousness criterion medically significant). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (blood showed lupus) (seriousness criterion medically significant), CONDITION AGGRAVATED (another bell's palsy attack) (seriousness criterion medically significant), WEIGHT INCREASED (gain weight), AUTOIMMUNE DISORDER (autoimmune disease), the first episode of FOOT DEFORMITY (HAMMER TOES/KNOT UNDERNEATH THAT WAS PAINFUL AND IT WAS CURVED), SOMNOLENCE (SLEEPY FROM COVID SHOT/ SLEPT FOR TWO DAYS), LACRIMATION INCREASED (watering eyes), ECZEMA (eczema gotten really bad on hands and feet), HYPOAESTHESIA (FACE NUMB AND TINGLING), BONE DISORDER (bone disorder), PAIN IN EXTREMITY (sore arm), PARAESTHESIA (face tingling), NECK PAIN (neck pain/ hurting really bad and pulling on her neck), BACK PAIN (back pain/ hurting really bad and pulling on her neck and back), SLUGGISHNESS (SLUGGISH AFTER SECOND VACCINE), PSORIASIS (psoriasis), SKIN BACTERIAL INFECTION (had bacteria on forehead and side of face), ALLERGIC COUGH (coughing from pollen), SEASONAL ALLERGY (pollen allergy), RHINORRHOEA (sniffling and blowing her nose), MUSCULAR DYSTROPHY (muscular dystrophy), SPONDYLITIS (arthritis made back stiff), BONE PAIN (bones hurt really bad), the second episode of FOOT DEFORMITY (HAMMER TOES/KNOT UNDERNEATH THAT WAS PAINFUL AND IT WAS CURVED), LACRIMATION INCREASED (RIGHT EYE POURS WITH WATER), PAIN (PAIN DUE TO CHANGE OF WEATHER FROM NECK ALL THE WAY DOWN), INJECTION SITE INDURATION (Painful nodule), VACCINATION SITE INDURATION (ARM SORE WITH LITTLE KNOT FROM COVID SHOT), VACCINATION SITE PAIN (FIRST COVID VACCINE ARM SORE, SECOND COVID VACCINE ARM SORE) and FATIGUE (TIRED FROM COVID SHOT). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (blood showed lupus), BELL'S PALSY (BELLE PALSY ATTACK/DUE TO WEATHER), CONDITION AGGRAVATED (another bell's palsy attack), AUTOIMMUNE DISORDER (autoimmune disease), LACRIMATION INCREASED (watering eyes), ECZEMA (eczema gotten really bad on hands and feet), HYPOAESTHESIA (FACE NUMB AND TINGLING), BONE DISORDER (bone disorder), PARAESTHESIA (face tingling), NECK PAIN (neck pain/ hurting really bad and pulling on her neck), BACK PAIN (back pain/ hurting really bad and pulling on her neck and back), ALLERGIC COUGH (coughing from pollen), SEASONAL ALLERGY (pollen allergy), RHINORRHOEA (sniffling and blowing her nose), MUSCULAR DYSTROPHY (muscular dystrophy), SPONDYLITIS (arthritis made back stiff), BONE PAIN (bones hurt really bad), the last episode of FOOT DEFORMITY (HAMMER TOES/KNOT UNDERNEATH THAT WAS PAINFUL AND IT WAS CURVED), LACRIMATION INCREASED (RIGHT EYE POURS WITH WATER), PAIN (PAIN DUE TO CHANGE OF WEATHER FROM NECK ALL THE WAY DOWN) and INJECTION SITE INDURATION (Painful nodule) had not resolved, WEIGHT INCREASED (gain weight) outcome was unknown, SOMNOLENCE (SLEEPY FROM COVID SHOT/ SLEPT FOR TWO DAYS), PAIN IN EXTREMITY (sore arm), SLUGGISHNESS (SLUGGISH AFTER SECOND VACCINE), VACCINATION SITE INDURATION (ARM SORE WITH LITTLE KNOT FROM COVID SHOT), VACCINATION SITE PAIN (FIRST COVID VACCINE ARM SORE, SECOND COVID VACCINE ARM SORE) and FATIGUE (TIRED FROM COVID SHOT) had resolved and INFLUENZA (flu), SINUSITIS (sinus infection), PSORIASIS (psoriasis) and SKIN BACTERIAL INFECTION (had bacteria on forehead and side of face) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: lupus (normal) lupus. On an unknown date, Body mass index increased: weight gain (Inconclusive) weight gain. On an unknown date, X-ray: lupus (Inconclusive) lupus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.  Very limited information regarding these events have been provided at this time. at therapy date and onset of the events is lacking as events are confounded by the concomitant medication-Humira.  Additional information has been requested   This case was linked to MOD-2021-104950 (E2B Linked Report).; Sender's Comments: Very limited information regarding these events have been provided at this time. at therapy date and onset of the events is lacking as events are confounded by the concomitant medication-Humira.  Additional information has been requested MOD-2021-104950:Same patient, 2nd dose