Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Immunisation reaction, Poor peripheral circulation, Ultrasound Doppler
Clinical narrative: Cataract aggravated; Poor peripheral circulation; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract aggravated) in a 63-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 UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-alcohol user (Drinks whiskey, bourbon and rum everyday for at least two glasses) from 1973 to 1983, Cataract operation on 02-Sep-2021, Cataract operation (other eye) on 16-Sep-2021 and Leg operation on 07-Nov-2021. Concurrent medical conditions included Tobacco user (A pack of cigarette a day) since 1973, Type II diabetes mellitus, Lung nodule and Allergy to animal (cat hair allergy manifestated by hives). Concomitant products included AMITRIPTYLINE for Anxiety, ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, EZETIMIBE and ROSUVASTATIN for Cholesterol, FOLIC ACID for Prevention, METHOTREXATE for Rheumatoid arthritis, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART, EMPAGLIFLOZIN (JARDIANCE) and GLIMEPIRIDE for Type II diabetes mellitus.   In 2019, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram twice a day. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In August 2021, the patient experienced CATARACT (Cataract aggravated) (seriousness criterion medically significant) and POOR PERIPHERAL CIRCULATION (Poor peripheral circulation). The patient was treated with Surgery (cataract surgery) for Cataract and Surgery (leg surgery) for Poor peripheral circulation. In 2021, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. In September 2021, CATARACT (Cataract aggravated) had resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Poor peripheral circulation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Ultrasound Doppler: Poor blood circulation in legs.         It was reported that, the patient had cataracts on both eyes but it was not specified which eye had the surgery on those dates.   The patient had bone density scan on 16-Dec-2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 a 63 year old female patient with concurrent 2 diabetes mellitus, who experienced the unexpected, serious (medically significant) event of Cataract (reported as Cataract aggravated) approximately 6 months after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose, 1 month ago, with no reported adverse events. She underwent cataract surgery during the following month. Concurrent type 2 diabetes mellitus could be a risk factor for the event. No information on detailed clinical course and relevant investigations was available in the report. The event resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to (Patient Link). Sender's Comments: This spontaneous case concerns a 63 year old female patient with concurrent 2 diabetes mellitus, who experienced the unexpected, serious (medically significant) event of Cataract (reported as Cataract aggravated) approximately 6 months after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose, 1 month ago, with no reported adverse events. She underwent cataract surgery during the following month. Concurrent type 2 diabetes mellitus could be a risk factor for the event. No information on detailed clinical course and relevant investigations was available in the report. The event resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.