Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy, Contusion, Granuloma, Impaired healing
Clinical narrative: wound on right leg; Granuloma on left leg was painful; Infection on right leg; bruising on right leg that turned green; Slowhealing wound/took some time; Possible colitis; Granuloma on left leg; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (wound on right leg), PAIN IN EXTREMITY (Granuloma on left leg was painful), LOCALISED INFECTION (Infection on right leg), CONTUSION (bruising on right leg that turned green) and IMPAIRED HEALING (Slowhealing wound/took some time) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    The patient's past medical history included Skin irritation (Latex allergy manifested by skin irritation/hurt), Anaphylaxis (Penicillin allergy manifested by anaphylaxis), Skin pain (Latex allergy manifested by skin irritation/hurt) and Heart attack (Penicillin allergy manifested by heart attack). Concurrent medical conditions included Psoriatic arthritis, Latex allergy (Latex allergy manifested by skin irritation/hurt), Penicillin allergy (Penicillin allergy manifested by blow up), Alcohol use (Alcohol use/one beer every six months), Tobacco user (Tobacco use/a pack a day), Allergic edema (Penicillin allergy manifested by blow up), Blood pressure high and High cholesterol. Concomitant products included IRBESARTAN for Blood pressure high, ROSUVASTATIN CALCIUM (ROSUVASTATIN [ROSUVASTATIN CALCIUM]) for High cholesterol, METHYLPREDNISOLONE, ZOLPIDEM TARTRATE (ZOLPIDEM [ZOLPIDEM TARTRATE]), GABAPENTIN, POTASSIUM, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and IBUPROFEN SODIUM for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram once a day. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram every two weeks. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. On an unknown date, the patient experienced LIMB INJURY (wound on right leg), PAIN IN EXTREMITY (Granuloma on left leg was painful), LOCALISED INFECTION (Infection on right leg), CONTUSION (bruising on right leg that turned green), IMPAIRED HEALING (Slowhealing wound/took some time), COLITIS (Possible colitis) and GRANULOMA (Granuloma on left leg). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, LIMB INJURY (wound on right leg), IMPAIRED HEALING (Slowhealing wound/took some time) and GRANULOMA (Granuloma on left leg) was resolving, PAIN IN EXTREMITY (Granuloma on left leg was painful), CONTUSION (bruising on right leg that turned green) and COLITIS (Possible colitis) had resolved and LOCALISED INFECTION (Infection on right leg) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Colonoscopy: Normal.         It was unknown whether patient was enrolled in COVID-19-Vaccine Trial. The reporter causality for the events Lower limb wound, Granuloma, Bruising of leg, Leg infection, leg pain with co-suspect humira was provided as not assessable. The reporter causality for the events Colitis, Healing delayed with co-suspect humira was provided as not related and not reported.