Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Cellulitis, Chills, Computerised tomogram, Diarrhoea
Clinical narrative: Cellulitis of legs; Infections; Skin Breakdown; Skin peeling; Laceration of leg; Hives; Swelling of legs; Arthritis; skin red; Sickness; diverticulitis; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sickness), CELLULITIS (Cellulitis of legs), INFECTION (Infections), SKIN DISORDER (Skin Breakdown), SKIN EXFOLIATION (Skin peeling), SKIN LACERATION (Laceration of leg), URTICARIA (Hives), PERIPHERAL SWELLING (Swelling of legs), ARTHRITIS (Arthritis), CHILLS (chills), DIVERTICULITIS (diverticulitis) and ERYTHEMA (skin red) in a 68-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 product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included CALCIUM, VITAMIN D3, SIMVASTATIN, GABAPENTIN, OMEPRAZOLE, DICLOFENAC, METHOTREXATE, METOPROLOL TARTRATE and LOSARTAN POTASSIUM for an unknown indication.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHILLS (chills) (seriousness criterion hospitalization). On 18-Apr-2021, the patient experienced DIVERTICULITIS (diverticulitis) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced ILLNESS (Sickness) (seriousness criterion hospitalization). On an unknown date, the patient experienced CELLULITIS (Cellulitis of legs) (seriousness criteria hospitalization and medically significant), INFECTION (Infections) (seriousness criterion hospitalization), SKIN DISORDER (Skin Breakdown) (seriousness criterion hospitalization), SKIN EXFOLIATION (Skin peeling) (seriousness criterion hospitalization), SKIN LACERATION (Laceration of leg) (seriousness criterion hospitalization), URTICARIA (Hives) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Swelling of legs) (seriousness criterion hospitalization), ARTHRITIS (Arthritis) (seriousness criterion hospitalization), ERYTHEMA (skin red) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea). The patient was treated with CIPROFLOXACIN from February 2021 to 19-May-2021 at a dose of 1 dosage form; METRONIDAZOLE from February 2021 to 19-May-2021 at a dose of 500 mg; DOXYCYCLINE from February 2021 to 19-May-2021 at a dose of 1 dosage form and CLINDAMYCIN at a dose of 200 milligram four times per day. At the time of the report, ILLNESS (Sickness) had not resolved, CELLULITIS (Cellulitis of legs), SKIN DISORDER (Skin Breakdown), SKIN EXFOLIATION (Skin peeling), SKIN LACERATION (Laceration of leg), URTICARIA (Hives), PERIPHERAL SWELLING (Swelling of legs), ARTHRITIS (Arthritis), ERYTHEMA (skin red) and DIARRHOEA (diarrhea) outcome was unknown, INFECTION (Infections) had resolved and CHILLS (chills) and DIVERTICULITIS (diverticulitis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: no infection (Inconclusive) no infection found in body..         It was reported that, in Feb 2021, the patient received 2nd dose Moderna vaccine. Computed tomography scan showed no infection found in the body. In 2021, her legs got bigger and called physician and went to the emergency room, hospital thought it was cellulitis prescribed metronidazole. In Feb 2021 and legs were about the same. In Apr or May 2021, legs got much worsened, getting cuts like legs were breaking. The patient was applying ice twice a day. On 18 Apr 2021, she was diagnosed with diverticulitis. She had abdominal pain and chills every night, although denied temperature. In May 2021, she was sick for four weeks and had been in and out of the hospital with infection during that time she did not take Humira. She was on antibiotic. In May 2021, she took a Humira injection and next day broke out with hives on her arms. Her last day of antibiotics was 19 May 2021. She reported went to physician initially about legs. The physician prescribed clindamycin 200 milligram, four times a day for five days. Her ankles started to break down, and two other spots. Skin looks peeled and red, legs were huge and could not wear shoes. Second hospital said that was not cellulitis and it looked like it was veins, could be arthritis. She also had diarrhea for four months.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood test: result was not provided.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-219970 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.