Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Polyp, Post procedural diarrhoea, SARS-CoV-2 test, Weight
Clinical narrative: PROGRESSION OF CATARACT/WORSENED VISION; Lost weight; Constipation; EYE PRESSURE ISSUE IN BOTH EYES; Polyps; Abdominal hernia; LOT OF DIARRHEA DUE TO PRE-EXISTING SURGERIES FOR CROHN'S DISEASE; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (PROGRESSION OF CATARACT/WORSENED VISION) in a 64-year-old male 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 products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Scar, Small bowel resection, Surgery (The patient had five surgeries since 1991 related to Crohn's disease, scar tissue and small bowel resection prior to taking Humira.) in 1991 and Polyp removal. Previously administered products included for Product used for unknown indication: MEREPRINE. Past adverse reactions to the above products included Rash with MEREPRINE. Concurrent medical conditions included Cataract, Abstains from alcohol, Non-smoker and Crohn's disease.   In 2007, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced CATARACT (PROGRESSION OF CATARACT/WORSENED VISION) (seriousness criterion medically significant), WEIGHT DECREASED (Lost weight), CONSTIPATION (Constipation), OCULAR DISCOMFORT (EYE PRESSURE ISSUE IN BOTH EYES), POLYP (Polyps), ABDOMINAL HERNIA (Abdominal hernia), POST PROCEDURAL DIARRHOEA (LOT OF DIARRHEA DUE TO PRE-EXISTING SURGERIES FOR CROHN'S DISEASE) and FATIGUE (TIRED). At the time of the report, CATARACT (PROGRESSION OF CATARACT/WORSENED VISION) and POST PROCEDURAL DIARRHOEA (LOT OF DIARRHEA DUE TO PRE-EXISTING SURGERIES FOR CROHN'S DISEASE) had not resolved and WEIGHT DECREASED (Lost weight), CONSTIPATION (Constipation), OCULAR DISCOMFORT (EYE PRESSURE ISSUE IN BOTH EYES), POLYP (Polyps), ABDOMINAL HERNIA (Abdominal hernia) and FATIGUE (TIRED) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: (Positive) positive. On 11-Feb-2021, Investigation: Worsening vision. On an unknown date, Weight: lost weight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient still had a lot of diarrhea because of previous surgeries due to Crohn's disease. In Nov 2020, patient was tested positive for covid-19. There was a progression of the cataract and the worsening of vision had started for patient. Patient underwent cataract surgery in right eye on 13 May 2021 and in left eye on 20 May 2021 and also stents were put in both eyes to relieved eye pressure. Patient was tired due to a lot of yard work. Patient also lost weight and was trying to gain weight. Patient was taking 10 to 15 unspecified concomitant medications. The alternative etiology for worsened vision and progression of cataract was ageing. Patient had not agreed to contact physician. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns 64-years-old male patient with concurrent condition of Crohn's disease.  treated with ADALIMUMAB (HUMIRA) and Cataract, who experienced the unexpected serious (medically significant) event of Cataract (cataract aggravated) and along with the non-serious event, which occurred in context to first dose of mRNA-1273 vaccine. There was a progression of the cataract and the worsening of vision. Patient underwent cataract surgery in right eye and in left eye and stents were put in both eyes to relieved eye pressure. He also lost weight and was trying to gain weight. He was taking 10 to 15 unspecified concomitant medications. The concurrent condition of Crohn's disease treated with ADALIMUMAB (HUMIRA) and Cataract remains the confounder for the event cataract. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received wherein added medical history, events and causality.; Sender's Comments: This spontaneous case concerns 64-years-old male patient with concurrent condition of Crohn's disease.  treated with ADALIMUMAB (HUMIRA) and Cataract, who experienced the unexpected serious (medically significant) event of Cataract (cataract aggravated) and along with the non-serious event, which occurred in context to first dose of mRNA-1273 vaccine. There was a progression of the cataract and the worsening of vision. Patient underwent cataract surgery in right eye and in left eye and stents were put in both eyes to relieved eye pressure. He also lost weight and was trying to gain weight. He was taking 10 to 15 unspecified concomitant medications. The concurrent condition of Crohn's disease treated with ADALIMUMAB (HUMIRA) and Cataract remains the confounder for the event cataract. The benefit-risk relationship of mRNA-1273 is not affected by this report.