Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Shoulder operation, Vaccination site bruising, Vaccination site nodule, Vaccination site urticaria
Clinical narrative: KNOT DUE TO COVID VACCINE; Insomnia; BRUISE DUE TO COVID VACCINE; WELPS AT INJECTION SITE; FATIGUE DUE TO COVID; POLYCHONDRITIS FLARE; POLYCHONDRITIS FLARE; SURGERY TO REPAIR LEFT SHOULDER; SPIDER BITE THAT BECAME NECROTIC; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER OPERATION (SURGERY TO REPAIR LEFT SHOULDER), POLYCHONDRITIS (POLYCHONDRITIS FLARE) and CONDITION AGGRAVATED (POLYCHONDRITIS FLARE) in a 57-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 Ulcerative colitis.    The patient's past medical history included Mastectomy in 2007. Concurrent medical conditions included Colitis ulcerative (MODERATE TO SEVERE ULCERATIVE COLITIS).   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. In 2021, the patient experienced ARTHROPOD BITE (SPIDER BITE THAT BECAME NECROTIC). On 30-Mar-2022, the patient experienced SHOULDER OPERATION (SURGERY TO REPAIR LEFT SHOULDER) (seriousness criterion medically significant). On an unknown date, the patient experienced POLYCHONDRITIS (POLYCHONDRITIS FLARE) (seriousness criterion medically significant), CONDITION AGGRAVATED (POLYCHONDRITIS FLARE) (seriousness criterion medically significant), VACCINATION SITE NODULE (KNOT DUE TO COVID VACCINE), INSOMNIA (Insomnia), VACCINATION SITE BRUISING (BRUISE DUE TO COVID VACCINE), VACCINATION SITE URTICARIA (WELPS AT INJECTION SITE) and FATIGUE (FATIGUE DUE TO COVID). At the time of the report, SHOULDER OPERATION (SURGERY TO REPAIR LEFT SHOULDER), POLYCHONDRITIS (POLYCHONDRITIS FLARE), CONDITION AGGRAVATED (POLYCHONDRITIS FLARE), ARTHROPOD BITE (SPIDER BITE THAT BECAME NECROTIC), VACCINATION SITE NODULE (KNOT DUE TO COVID VACCINE), INSOMNIA (Insomnia), VACCINATION SITE BRUISING (BRUISE DUE TO COVID VACCINE), VACCINATION SITE URTICARIA (WELPS AT INJECTION SITE) and FATIGUE (FATIGUE DUE TO COVID) outcome was unknown.            No concomitant medication was provided by reporter. No treatment drug was provided by reporter.  Causality for HUMIRA: The reporter's causality for the event(s) of SURGERY TO REPAIR LEFT SHOULDER, SPIDER BITE THAT BECAME NECROTIC, KNOT DUE TO COVID VACCINE, INSOMNIA, POLYCHONDRITIS FLARE, BRUISE DUE TO COVID VACCINE and FATIGUE DUE TO COVID VACCINE was not provided. The reporter's causality for the event(s) of WELPS AT INJECTION SITE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Company comment This is a spontaneous case reported by a consumer concerning a 57-year-old female patient with relevant medical history of ulcerative colitis treated with Adalimumab (reported as co-suspect drug), who experienced the unexpected, serious, medically significant events of shoulder operation (reported as surgery to repair left shoulder), polychondritis and condition aggravated. The patient received three doses of mRNA-1273. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. No further information regarding the course of the events, studies performed and treatment received was provided. The medical history of ulcerative colitis could be associated with the event polychondritis. The non-serious event of spider bite in an unspecified location could be a confounder for shoulder operation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer concerning a 57-year-old female patient with relevant medical history of ulcerative colitis treated with Adalimumab (reported as co-suspect drug), who experienced the unexpected, serious, medically significant events of shoulder operation (reported as surgery to repair left shoulder), polychondritis and condition aggravated. The patient received three doses of mRNA-1273. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. No further information regarding the course of the events, studies performed and treatment received was provided. The medical history of ulcerative colitis could be associated with the event polychondritis. The non-serious event of spider bite in an unspecified location could be a confounder for shoulder operation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.