Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Suicidal ideation, Vaccination site pain
Clinical narrative: Depression; removal and reattachment of big chunk of colon leaking and abscess in gut; removal and reattachment of big chunk of colon leaking and abscess in gut; valve that allowed metering of bile going in and out/ bile dumps continually; Head was kind of swimmy; Burns around bottom from bile came out/ really painful; burned around bottom from bile came out, was really painful; Arthralgia aggravated/pain of  rheumatoid arthritis has worsened in hands and joints; Diarrhea aggravated/ worsening of constant diarrhea; mentioned shooting self during call; She was dehydrated; SORE ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), INTESTINAL BARRIER DYSFUNCTION (removal and reattachment of big chunk of colon leaking and abscess in gut), ABDOMINAL ABSCESS (removal and reattachment of big chunk of colon leaking and abscess in gut), POST PROCEDURAL BILE LEAK (valve that allowed metering of bile going in and out/ bile dumps continually), HEAD DISCOMFORT (Head was kind of swimmy), ANORECTAL DISCOMFORT (Burns around bottom from bile came out/ really painful), PROCTALGIA (burned around bottom from bile came out, was really painful), RHEUMATOID ARTHRITIS (Arthralgia aggravated/pain of  rheumatoid arthritis has worsened in hands and joints), DIARRHOEA (Diarrhea aggravated/ worsening of constant diarrhea), SUICIDAL IDEATION (mentioned shooting self during call) and VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) in a 56-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 Rheumatoid arthritis.    The patient's past medical history included Surgery (botched surgery from 30 years ago) in 1992. Concurrent medical conditions included Diarrhea (Since 1992, the patient had ongoing diarrhea) since 1992.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2022, the patient experienced VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) (seriousness criterion medically significant). On an unknown date, the patient experienced DEPRESSION (Depression) (seriousness criterion medically significant), INTESTINAL BARRIER DYSFUNCTION (removal and reattachment of big chunk of colon leaking and abscess in gut) (seriousness criterion medically significant), ABDOMINAL ABSCESS (removal and reattachment of big chunk of colon leaking and abscess in gut) (seriousness criterion medically significant), POST PROCEDURAL BILE LEAK (valve that allowed metering of bile going in and out/ bile dumps continually) (seriousness criterion medically significant), HEAD DISCOMFORT (Head was kind of swimmy) (seriousness criterion medically significant), ANORECTAL DISCOMFORT (Burns around bottom from bile came out/ really painful) (seriousness criterion medically significant), PROCTALGIA (burned around bottom from bile came out, was really painful) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Arthralgia aggravated/pain of  rheumatoid arthritis has worsened in hands and joints) (seriousness criterion medically significant), DIARRHOEA (Diarrhea aggravated/ worsening of constant diarrhea) (seriousness criterion medically significant), SUICIDAL IDEATION (mentioned shooting self during call) (seriousness criterion medically significant) and DEHYDRATION (She was dehydrated). The patient was treated with CHOLESTYRAMINE at an unspecified dose and frequency. In April 2022, VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) had resolved. At the time of the report, DEPRESSION (Depression) had not resolved and INTESTINAL BARRIER DYSFUNCTION (removal and reattachment of big chunk of colon leaking and abscess in gut), ABDOMINAL ABSCESS (removal and reattachment of big chunk of colon leaking and abscess in gut), POST PROCEDURAL BILE LEAK (valve that allowed metering of bile going in and out/ bile dumps continually), HEAD DISCOMFORT (Head was kind of swimmy), ANORECTAL DISCOMFORT (Burns around bottom from bile came out/ really painful), PROCTALGIA (burned around bottom from bile came out, was really painful), RHEUMATOID ARTHRITIS (Arthralgia aggravated/pain of  rheumatoid arthritis has worsened in hands and joints), DIARRHOEA (Diarrhea aggravated/ worsening of constant diarrhea), SUICIDAL IDEATION (mentioned shooting self during call) and DEHYDRATION (She was dehydrated) outcome was unknown.            No concomitant details were provided. Unknown date patient had appendectomy. It was reported that since 1992, the patient had ongoing diarrhea that had gotten worse in 2022 and had twelve or more times a day. Patient stated something else was taken left with constant diarrhea and nothing can slow it down or stop it, had to go eight times a day. Patient was on new online therapy. Patient brain was dead with memory. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was linked to MOD-2022-584794, MOD-2022-584795 (Patient Link).  Company Comment: This spontaneous case reported by a consumer concerns a 56-year-old, female patient with no relevant medical history, concomitant medication Adalimumab, who experienced the unexpected, serious, medically significant, events of Vaccination Site Pain, Depression, intestinal barrier dysfunction, Abdominal Abscess, Post procedural bile leak, Head Discomfort, anorectal discomfort, proctalgia, rheumatoid arthritis, Diarrhoea, Suicidal Ideation and Dehydration. The exact date of onset of the events were not specified with respect to the administration of the fourth dose of mRNA-1273, hence latency could not be assessed. It was reported that since 1992, the patient had ongoing diarrhea that had gotten worse in 2022 and had twelve or more times a day, constantly. Patient was dehydrated and it burned around bottom where bile came out, was painful. Cholestyramine regimen worked really well. Removal and reattachment of big chunk of colon leaking and abscess in gut and valve that allowed metering of bile went in and out. Bile dumped continually. Pain of rheumatoid arthritis in hands and joints since being dehydrated. Patient was fighting depression per covid pandemic and mentioned shooting self during call if could not find COVID vaccination card.  Patient head was kind of swimmy, had ongoing physical problem and depression. Patient was on new online therapy. The patient started Adalimumab on an unknown date, which could be a confounder for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.; Sender's Comments: This spontaneous case reported by a consumer concerns a 56-year-old, female patient with no relevant medical history, concomitant medication Adalimumab, who experienced the unexpected, serious, medically significant, events of Vaccination Site Pain, Depression, intestinal barrier dysfunction, Abdominal Abscess, Post procedural bile leak, Head Discomfort, anorectal discomfort, proctalgia, rheumatoid arthritis, Diarrhoea, Suicidal Ideation and Dehydration. The exact date of onset of the events were not specified with respect to the administration of the fourth dose of mRNA-1273, hence latency could not be assessed. It was reported that since 1992, the patient had ongoing diarrhea that had gotten worse in 2022 and had twelve or more times a day, constantly. Patient was dehydrated and it burned around bottom where bile came out, was painful. Cholestyramine regimen worked really well. Removal and reattachment of big chunk of colon leaking and abscess in gut and valve that allowed metering of bile went in and out. Bile dumped continually. Pain of rheumatoid arthritis in hands and joints since being dehydrated. Patient was fighting depression per covid pandemic and mentioned shooting self during call if could not find COVID vaccination card.  Patient head was kind of swimmy, had ongoing physical problem and depression. Patient was on new online therapy. The patient started Adalimumab on an unknown date, which could be a confounder for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per source document.