Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chronic fatigue syndrome, Cutaneous lupus erythematosus, Fibromyalgia, Loss of personal independence in daily activities
Clinical narrative: Ever since she has received the vaccine she can't do anything; In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia; In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia; Acute tendonitis; Post vaccine long COVID; Left leg had swollen at one point; Was diagnosed as having some sort of clot, but it was not a blood clot; Diagnosed with urticaria hives, which she states is an immune response; In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia; Approximately a month after receiving the 1st dose, she started experiencing itching in her head; Experienced fevers of 104F; Vomiting for 2 days; This spontaneous case was reported by a patient and describes the occurrence of CUTANEOUS LUPUS ERYTHEMATOSUS (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy and Allergic to cats (Minor allergy to cats). Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced PRURITUS (Approximately a month after receiving the 1st dose, she started experiencing itching in her head). On an unknown date, the patient experienced CUTANEOUS LUPUS ERYTHEMATOSUS (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Ever since she has received the vaccine she can't do anything), CHRONIC FATIGUE SYNDROME (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia), FIBROMYALGIA (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia), TENDONITIS (Acute tendonitis), POST-ACUTE COVID-19 SYNDROME (Post vaccine long COVID), PERIPHERAL SWELLING (Left leg had swollen at one point), MASS (Was diagnosed as having some sort of clot, but it was not a blood clot), URTICARIA (Diagnosed with urticaria hives, which she states is an immune response), PYREXIA (Experienced fevers of 104F) and VOMITING (Vomiting for 2 days). The patient was treated with PREGABALIN for Tendonitis, at an unspecified dose and frequency; MELOXICAM at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) at an unspecified dose and frequency. At the time of the report, CUTANEOUS LUPUS ERYTHEMATOSUS (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia), PRURITUS (Approximately a month after receiving the 1st dose, she started experiencing itching in her head), CHRONIC FATIGUE SYNDROME (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia), FIBROMYALGIA (In addition to the urticaria hives, she has skin lupus, chronic fatigue syndrome, and fibromyalgia), TENDONITIS (Acute tendonitis), POST-ACUTE COVID-19 SYNDROME (Post vaccine long COVID) and URTICARIA (Diagnosed with urticaria hives, which she states is an immune response) had not resolved, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Ever since she has received the vaccine she can't do anything) and PERIPHERAL SWELLING (Left leg had swollen at one point) outcome was unknown and MASS (Was diagnosed as having some sort of clot, but it was not a blood clot), PYREXIA (Experienced fevers of 104F) and VOMITING (Vomiting for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 F. On an unknown date, Magnetic resonance imaging: Diagnosed as having some sort of clot, but it was not a blood clot.. On an unknown date, Ultrasound scan: Diagnosed as having some sort of clot, but it was not a blood clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient has never been diagnosed with or tested positive for COVID-19.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient was always a very active and healthy individual prior to receiving the vaccine. She was never sick in her life but approximately a month after receiving the first dose, she started experiencing itching in her head. It got so bad after the second dose that she had to go see a Dermatologist in Apr-2021. She was diagnosed with urticaria hives, which she states is an immune response. She has lost approximately 70% of her hair due to this at the time of report. In addition to the urticaria hives, she had skin lupus, chronic fatigue syndrome, and fibromyalgia. Doctor prescribed her pregabalin which seems to help a bit with the acute tendonitis. Her tendons were so painful that she cannot get out of bed, and it felt like her entire body is on fire. Her left leg had swollen at one point.  Events of urticaria hives, skin lupus, fibromyalgia, acute tendonitis, chronic fatigue syndrome cause patient to seek office visits to about 15 doctors (specialists). The patient has not experienced a similar event in the past. The symptoms worsened initially. Stable with treatment but was not going away.    Fever of 104 and vomiting caused patient to seek office visits to about 15 doctors, orthro muscles were bad, rheum, derm.  Company Comment:  This is a spontaneous case concerning a 71-year-old female patient with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Cutaneous lupus erythematosus and unexpected and non-serious AESI of fibromyalgia among other non-serious events. The events occurred unknown days after a second dose of mRNA-1273. Patient states she has been experiencing the events after the first dose of vaccine, but they got worsen after the second. She had to see a dermatologist in April 2021 when she was diagnosed with urticaria hives. She also had to get an MRI because her left leg was swollen. The MRI and ultrasound showed a clot in the leg different than a blood clot. She was treated with steroids with an improvement. At the time of the report the events were not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-624324, US-MODERNATX, INC.-MOD-2021-624342 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Cutaneous lupus erythematosus and unexpected and non-serious AESI of fibromyalgia among other non-serious events. The events occurred unknown days after a second dose of mRNA-1273. Patient states she has been experiencing the events after the first dose of vaccine, but they got worsen after the second. She had to see a dermatologist in April 2021 when she was diagnosed with urticaria hives. She also had to get an MRI because her left leg was swollen. The MRI and ultrasound showed a clot in the leg different than a blood clot. She was treated with steroids with an improvement. At the time of the report the events were not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-624324:Booster dose case US-MODERNATX, INC.-MOD-2021-624342:Dose 1 case