Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Colonoscopy, Feeling abnormal
Clinical narrative: Polyp; Feeling off when nearing injection day and discomfort in stomach close to injection day; Feeling off when nearing injection day and discomfort in stomach close to injection day; Pangs at random intervals on different parts of body; Back pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of POLYP (Polyp) in a 26-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) solution for injection for Ulcerative colitis.  Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis).  On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced POLYP (Polyp) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling off when nearing injection day and discomfort in stomach close to injection day), ABDOMINAL DISCOMFORT (Feeling off when nearing injection day and discomfort in stomach close to injection day), PAIN (Pangs at random intervals on different parts of body), BACK PAIN (Back pain) and ARTHRALGIA (Joint pain). The patient was treated with Surgery (Polyp removed) for Polyp. At the time of the report, POLYP (Polyp) was resolving, FEELING ABNORMAL (Feeling off when nearing injection day and discomfort in stomach close to injection day) had not resolved, ABDOMINAL DISCOMFORT (Feeling off when nearing injection day and discomfort in stomach close to injection day) outcome was unknown and PAIN (Pangs at random intervals on different parts of body), BACK PAIN (Back pain) and ARTHRALGIA (Joint pain) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: abnormal (abnormal) Polyps found.  No concomitant medication was reported. Patient was feeling off when nearing injection day as well as experiencing discomfort in stomach close to injection day. Patient had polyp removed during routine colonoscopy. Patient received second COVID 19 booster and stated aches, joint and back pain consistent with pre Humira symptoms and pangs at random intervals on different parts of body. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of polyp, joint pain, back pain and pangs at random intervals on different parts of body with Humira was no reasonable possibility. The reporter's causality for the events of feeling off when nearing injection day and discomfort in stomach close to injection day with Humira was a reasonable possibility. The reporter's causality for the events of feeling off when nearing injection day and discomfort in stomach close to injection day was not provided. Sender's opinion was that there was no reasonable possibility that the events of polyp, feeling off when nearing injection day and discomfort in stomach close to injection day, feeling off when nearing injection day and discomfort in stomach close to injection day, joint pain, back pain and pangs at random intervals on different parts of body are related to Humira.  Company comment: This spontaneous case concerns a 26-year-old female patient, with medical history of Ulcerative colitis in treatment with ADALIMUMAB (Humira), who experienced the unexpected serious (medically significant) event of POLYP, together with other non-serious events, which occurred in the context of receiving the second booster of mRNA-1273 vaccine. Onset date of the event and vaccination dates were not provided; hence, latency cannot be assessed. Patient received 4 doses of mRNA-1273 vaccine on unknown dates. Patient was feeling off when nearing injection day as well as experiencing discomfort in stomach close to injection day. Patient had polyp removed during routine colonoscopy. Patient received second COVID 19 booster and stated aches, joint and back pain consistent with pre Humira symptoms and pangs at random intervals on different parts of body. Patient´s medical history of ulcerative colitis remains as a confounder for event POLYP. ADALIMUMAB was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26-year-old female patient, with medical history of Ulcerative colitis in treatment with ADALIMUMAB (Humira), who experienced the unexpected serious (medically significant) event of POLYP, together with other non-serious events, which occurred in the context of receiving the second booster of mRNA-1273 vaccine. Onset date of the event and vaccination dates were not provided; hence, latency cannot be assessed. Patient received 4 doses of mRNA-1273 vaccine on unknown dates. Patient was feeling off when nearing injection day as well as experiencing discomfort in stomach close to injection day. Patient had polyp removed during routine colonoscopy. Patient received second COVID 19 booster and stated aches, joint and back pain consistent with pre Humira symptoms and pangs at random intervals on different parts of body. Patient´s medical history of ulcerative colitis remains as a confounder for event POLYP. ADALIMUMAB was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.