Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Bone pain, Colitis ulcerative, Depression, Inappropriate schedule of product administration
Clinical narrative: ULCERATIVE COLITIS FLARE; MALNOURISHMENT CAUSED KNEES TO SEIZE; MALNOURISHMENT CAUSED KNEES TO SEIZE; SOFT TISSUE SEIZED UP; Depression; PAIN SKULL; PAIN IN RIGHT SHOULDER; Pain in arm; First dose on 25-MAR-2021 and second on 06-MAY-2021; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) in a 58-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 and Ulcerative colitis.    Concurrent medical conditions included Disability since 14-May-2020 and Ulcerative colitis since 14-May-2020.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received 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) Citrate Free. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-MAR-2021 and second on 06-MAY-2021). On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE) (seriousness criterion medically significant), MALNUTRITION (MALNOURISHMENT CAUSED KNEES TO SEIZE), JOINT STIFFNESS (MALNOURISHMENT CAUSED KNEES TO SEIZE), SOFT TISSUE DISORDER (SOFT TISSUE SEIZED UP), DEPRESSION (Depression), BONE PAIN (PAIN SKULL), ARTHRALGIA (PAIN IN RIGHT SHOULDER) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE), MALNUTRITION (MALNOURISHMENT CAUSED KNEES TO SEIZE), JOINT STIFFNESS (MALNOURISHMENT CAUSED KNEES TO SEIZE), SOFT TISSUE DISORDER (SOFT TISSUE SEIZED UP), DEPRESSION (Depression), BONE PAIN (PAIN SKULL), ARTHRALGIA (PAIN IN RIGHT SHOULDER), PAIN IN EXTREMITY (Pain in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-MAR-2021 and second on 06-MAY-2021) outcome was unknown.            No concomitant medications were reported.  Patient was administered HUMIRA Citrate free (Solution for injection in pre-filled pen) (ADALIMUMAB), 1159438.  The reporter's causality for the events of soft tissue seized up, depression, ulcerative colitis flare, malnourishment caused knees to seize up, pain in right shoulder, pain in arm and pain skull with HUMIRA was not provided.  The opinion was that there was no reasonable possibility that the events of malnourishment caused knees to seize up was related to HUMIRA(ADALIMUMAB).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 58-year-old, female patient with concurrent condition of Ulcerative colitis who experienced the unexpected, serious (medically significant) event of Colitis ulcerative aggravated which occurred on unknown interval after receiving the third dose of mRNA-1273. Inappropriate schedule of vaccine administered was noted in the case as the second dose was administered 42 days after the first dose. The patient developed disability due to Ulcerative colitis 10 months before receiving the first dose of mRNA-1273 and reported disease flares on unknown dates after receiving the third dose of mRNA-1273 and the co-suspect, non-company product Adalimumab. The event occurred with non-serious events of Malnutrition, Depression, Bone pain, Joint stiffness, Soft tissue disorder, Arthralgia and Pain in arm. The clinical presentation of flares, clinical course, diagnostic evaluation and treatment details were not provided in the report. Ulcerative colitis can flare as part of natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Follow-up received on 15 Aug 2022-Medical History and Event added.; Sender's Comments: This spontaneous case concerns a 58-year-old, female patient with concurrent condition of Ulcerative colitis who experienced the unexpected, serious (medically significant) event of Colitis ulcerative aggravated which occurred on unknown interval after receiving the third dose of mRNA-1273. Inappropriate schedule of vaccine administered was noted in the case as the second dose was administered 42 days after the first dose. The patient developed disability due to Ulcerative colitis 10 months before receiving the first dose of mRNA-1273 and reported disease flares on unknown dates after receiving the third dose of mRNA-1273 and the co-suspect, non-company product Adalimumab. The event occurred with non-serious events of Malnutrition, Depression, Bone pain, Joint stiffness, Soft tissue disorder, Arthralgia and Pain in arm. The clinical presentation of flares, clinical course, diagnostic evaluation and treatment details were not provided in the report. Ulcerative colitis can flare as part of natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report