Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhoea aggravated; Vaccination site pain; Right cataract; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Right cataract) in a 76-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 Crohn's disease.    Concurrent medical conditions included Tobacco user and Allergy. Concomitant products included PARACETAMOL (TYLENOL) for Headache and Pain, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second 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) 40 milligram every two weeks. On 04-Nov-2021, the patient experienced CATARACT (Right cataract) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhoea aggravated) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with Surgery ("The patient had cataract surgery on right eye") for Cataract. At the time of the report, CATARACT (Right cataract) was resolving and DIARRHOEA (Diarrhoea aggravated) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No treatment medications were reported.  Company comment.  This spontaneous case concerns a 76  year  old, female patient, with relevant current condition of tobacco user, who experienced the serious (medically significant) unexpected event of cataract (right eye), approximately 8 months after the second dose of mRNA  1273 vaccine. The patient had cataract surgery on right eye on an unspecified date. No further clinical information was available for medical reviewing. Co  suspect product included Adalimumab. Patient´s age and smoking remain as confounders for cataract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant live follow up: Co-suspect strength and dose updated. On 26-Jan-2022: Significant live follow up: Patient Race, patient History, co-suspect information, concomitant drug, Outcome updated. event Cataract onset date updated.; Sender's Comments: This spontaneous case concerns a 76  year  old, female patient, with relevant current condition of tobacco user, who experienced the serious (medically significant) unexpected event of cataract (right eye), approximately 8 months after the second dose of mRNA  1273 vaccine. The patient had cataract surgery on right eye on an unspecified date. No further clinical information was available for medical reviewing. Co  suspect product included Adalimumab. Patient´s age and smoking remain as confounders for cataract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.