Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Eye inflammation, Stress
Clinical narrative: Flare ups; COVID-19; Eye inflammation; Stress; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflammation), STRESS (Stress), CONDITION AGGRAVATED (Flare ups) and COVID-19 (COVID-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Rheumatoid arthritis.    Concurrent medical conditions included Panuveitis (Non-infectious intermediate, posterior) and Rheumatoid arthritis (Moderate to severe).   On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In 2022, the patient experienced EYE INFLAMMATION (Eye inflammation) and STRESS (Stress). In August 2022, the patient experienced CONDITION AGGRAVATED (Flare ups) and COVID-19 (COVID-19). At the time of the report, EYE INFLAMMATION (Eye inflammation), STRESS (Stress), CONDITION AGGRAVATED (Flare ups) and COVID-19 (COVID-19) was resolving.            No concomitant product use was reported.   On an unspecified date, in 2022, the patient experienced eye inflammation and stress. On an unspecified date, in Aug-2022, the patient experienced flare ups and COVID-19.   Primary reporter contact for lot number information was unsuccessful for second regimen.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of Eye inflammation and Stress with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of Condition aggravated and COVID-19 was not provided with Humira (Adalimumab).  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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Follow-up received wherein event added, onset date of the event COVID-19, reporter causality of the event, co suspect drug information and narrative description updated.  Company comment: This spontaneous case concerns a 59-year-old, female patient with medical history of Non-infectious Intermediate, Posterior and Panuveitis and Moderate-to-severe Rheumatoid Arthritis both treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event COVID-19 and condition aggravated occurred unknown number of days after receiving Humira and unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Aug2022, hence, the onset latency could not be assessed. The start dates of the other events were reported as unspecified dates in 2022, hence, the onset latency also could not be assessed. It was reported that the patient experienced eye inflammation and stress. Approximately 3 to 4 months after vaccination, it was reported that the patient experienced flare-ups and COVID-19. Treatment information was not provided. However, the events were resolving at the time of the report. The medical history of Non-infectious Intermediate, Posterior and Panuveitis, which involves inflammation of all layers of the uvea of the eye which can flare up and recurrence is common, remains a confounder for the event eye inflammation. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event condition aggravated. The history of co-suspect administration of Humira also remains a confounder for the events eye inflammation and condition aggravated. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old, female patient with medical history of Non-infectious Intermediate, Posterior and Panuveitis and Moderate-to-severe Rheumatoid Arthritis both treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event COVID-19 and condition aggravated occurred unknown number of days after receiving Humira and unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Aug2022, hence, the onset latency could not be assessed. The start dates of the other events were reported as unspecified dates in 2022, hence, the onset latency also could not be assessed. It was reported that the patient experienced eye inflammation and stress. Approximately 3 to 4 months after vaccination, it was reported that the patient experienced flare-ups and COVID-19. Treatment information was not provided. However, the events were resolving at the time of the report. The medical history of Non-infectious Intermediate, Posterior and Panuveitis, which involves inflammation of all layers of the uvea of the eye which can flare up and recurrence is common, remains a confounder for the event eye inflammation. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event condition aggravated. The history of co-suspect administration of Humira also remains a confounder for the events eye inflammation and condition aggravated. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.