Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cataract, Diarrhoea, Illness, Pyrexia
Clinical narrative: progressive cataract; really sick; Diarrhea; Vomiting; Slight fever; sore hips/ hip hurts; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (progressive cataract) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 002A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient had no tobacco and abstained from alcohol.  The patient's past medical history included Pain, Inflammation and Cataract (on both of her eyes). Concurrent medical conditions included Drug allergy (methotrexate allergy manifested by increased liver enzymes.), Drug allergy (compazine allergy manifested by skin breakout and rashes), Cholesterol, Hypertension, Osteopenia, Hypothyroidism and Supplementation therapy. Concomitant products included ATORVASTATIN for Cholesterol and Hypertension, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, HYDROXYCHLOROQUINE for Inflammation, DENOSUMAB (PROLIA) for Osteopenia, TRAMADOL for Pain, TURMERIC [CURCUMA LONGA RHIZOME], VITAMIN D3, CALCIUM, MAGNESIUM and ZINC for Supplementation therapy.   In March 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRALGIA (sore hips/ hip hurts). On 28-Aug-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting) and PYREXIA (Slight fever). On an unknown date, the patient experienced CATARACT (progressive cataract) (seriousness criterion medically significant) and ILLNESS (really sick). On 30-Aug-2021, DIARRHOEA (Diarrhea), VOMITING (Vomiting) and PYREXIA (Slight fever) had resolved. At the time of the report, CATARACT (progressive cataract) and ARTHRALGIA (sore hips/ hip hurts) had not resolved and ILLNESS (really sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The reporter causality for the events of progressive cataract, sore hips, hip hurts, diarrhea, vomiting and slight fever with rinvoq(upadacitinib) was no reasonable possibility. the reporter causality for the events of really sick was not provided. When patient had the three doses of her covid19 vaccine and patient RINVOQ was put on hold for two weeks from the day the covid19 vaccine was administered. Patient had an unspecified blood work done in Aug 2021, but she did not know the result of the test.  No treatment medications were reported.  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 is a spontaneous case reported by a consumer. A 66-year-old female patient in treatment with UPADACITINIB (RINVOQ) for Rheumatoid arthritis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of progressive cataract. Onset date of the event was not provided; latency cannot be assessed. She already had cataract on both of her eyes prior to RINVOQ treatment but it was progressing until she was advised to had a cataract surgery done. She did not have any treatment for cataract yet and no laboratory test performed related to cataract. On the same date after booster dose, she experienced non serious events of diarrhea, vomiting and slight fever. Events lasted for 2 days, no consultation nor any treatment was performed. In addition, patient experienced non serious event of hip pain which could be related with current condition of rheumatoid arthritis. Patient's age and rheumatoid arthritis are risk factors for progressive cataract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 66-year-old female patient in treatment with UPADACITINIB (RINVOQ) for Rheumatoid arthritis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of progressive cataract. Onset date of the event was not provided; latency cannot be assessed. She already had cataract on both of her eyes prior to RINVOQ treatment but it was progressing until she was advised to had a cataract surgery done. She did not have any treatment for cataract yet and no laboratory test performed related to cataract. On the same date after booster dose, she experienced non serious events of diarrhea, vomiting and slight fever. Events lasted for 2 days, no consultation nor any treatment was performed. In addition, patient experienced non serious event of hip pain which could be related with current condition of rheumatoid arthritis. Patient's age and rheumatoid arthritis are risk factors for progressive cataract. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.