Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diverticulitis, Eye disorder, Lacrimal gland enlargement, Vaccination site pain
Clinical narrative: COVID-19; Eye disorder; Lacrimal gland enlargement/Swollen lacrimal gland on left eye; Vaccination site pain/Covid vaccine caused sore arm; Diverticulitis; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 75-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), the first episode of COVID-19 (COVID-19), EYE DISORDER (Eye disorder), LACRIMAL GLAND ENLARGEMENT (Lacrimal gland enlargement/Swollen lacrimal gland on left eye) and VACCINATION SITE PAIN (Vaccination site pain/Covid vaccine caused sore arm). In July 2022, the patient experienced the second episode of COVID-19 (COVID-19). At the time of the report, DIVERTICULITIS (Diverticulitis), the last episode of COVID-19 (COVID-19), LACRIMAL GLAND ENLARGEMENT (Lacrimal gland enlargement/Swollen lacrimal gland on left eye) and VACCINATION SITE PAIN (Vaccination site pain/Covid vaccine caused sore arm) outcome was unknown and EYE DISORDER (Eye disorder) had not resolved.            No concomitant medication information provided  The gland on left eye, diverticulitis and COVID vaccine caused sore arm. In Jan 2022, patient had COVID and had trouble with eyes. In Jul 2022, the patient was diagnosed with COVID. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the co-suspect RINVOQ (UPADACITINIB) for the events of trouble with eyes, had COVID onset in January 2022, had COVID onset in July 2022, swollen lacrimal gland on left eye, diverticulitis and COVID vaccine caused sore arm was not provided.  No treatment medication information provided  Company Comment : This is a spontaneous case concerning a 75-year-old female patient with a concurrent medical condition of Moderate to Severe Rheumatoid arthritis treated with Upadacitinib, given 3 doses of COVID-19 vaccine mRNA-1273, who experienced the unexpected serious event of Diverticulitis, the unexpected non-serious events of COVID-19(AESI) (2 episodes), Eye disorder, Lacrimal gland enlargement (swollen lacrimal gland on the left eye), and the expected non-serious event of Vaccination site pain. Approximately 4 ½ - 5 ½ months after the booster dose of COVID-19 vaccine mRNA-1273, the first episode of event COVID-19 occurred, then resolved at an unknown time. About 6 months later, the second episode of event COVID-19 occurred. All the other events occurred unknown number of days after the booster dose of mRNA-1273, given 5 months 22 days after the 2nd dose. The primary series given with an interval of 33 days. There is no available information regarding clinical course, diagnostic tests, and treatment medication. The patient's elderly age and use of Upadacitinib, which is an immunosuppressant, remain as predisposition risk factors for event COVID-19 while her Rheumatoid arthritis, which can cause several eye conditions like dry eye syndrome, uveitis, and scleritis, remains a confounder for event Eye disorder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with a concurrent medical condition of Moderate to Severe Rheumatoid arthritis treated with Upadacitinib, given 3 doses of COVID-19 vaccine mRNA-1273, who experienced the unexpected serious event of Diverticulitis, the unexpected non-serious events of COVID-19(AESI) (2 episodes), Eye disorder, Lacrimal gland enlargement (swollen lacrimal gland on the left eye), and the expected non-serious event of Vaccination site pain. Approximately 4 ½ - 5 ½ months after the booster dose of COVID-19 vaccine mRNA-1273, the first episode of event COVID-19 occurred, then resolved at an unknown time. About 6 months later, the second episode of event COVID-19 occurred. All the other events occurred unknown number of days after the booster dose of mRNA-1273, given 5 months 22 days after the 2nd dose. The primary series given with an interval of 33 days. There is no available information regarding clinical course, diagnostic tests, and treatment medication. The patient's elderly age and use of Upadacitinib, which is an immunosuppressant, remain as predisposition risk factors for event COVID-19 while her Rheumatoid arthritis, which can cause several eye conditions like dry eye syndrome, uveitis, and scleritis, remains a confounder for event Eye disorder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.