Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Medical device implantation, Post procedural complication, Uveitis
Clinical narrative: Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS; Medical device implantation / Implants in eyes; Post procedural complication /Allergic reaction to the solution that was used; Allergic reaction to the solution that was used; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS), MEDICAL DEVICE IMPLANTATION (Medical device implantation / Implants in eyes), POST PROCEDURAL COMPLICATION (Post procedural complication /Allergic reaction to the solution that was used) and HYPERSENSITIVITY (Allergic reaction to the solution that was used) in an adult 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced UVEITIS (Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS) (seriousness criterion medically significant), MEDICAL DEVICE IMPLANTATION (Medical device implantation / Implants in eyes) (seriousness criterion medically significant), POST PROCEDURAL COMPLICATION (Post procedural complication /Allergic reaction to the solution that was used) (seriousness criterion medically significant) and HYPERSENSITIVITY (Allergic reaction to the solution that was used) (seriousness criterion medically significant). At the time of the report, UVEITIS (Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS) had not resolved and MEDICAL DEVICE IMPLANTATION (Medical device implantation / Implants in eyes), POST PROCEDURAL COMPLICATION (Post procedural complication /Allergic reaction to the solution that was used) and HYPERSENSITIVITY (Allergic reaction to the solution that was used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset, IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset and INCREASED SYMPTOMS WITH UVEITIS was not provided.  AbbVie's opinion was that there was no reasonable possibility that the events of IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset, IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset, IMPLANTS IN EYES/ALLERGIC REACTION TO THE SOLUTION THAT WAS USED unknown onset and INCREASED SYMPTOMS WITH UVEITIS are related to HUMIRA(ADALIMUMAB).  No treatment medications were provided by the reporter.  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 adult  female patient of unspecified age with relevant medical history of INTERMEDIATE, POSTERIOR AND PANUVEITIS MODERATE TO SEVERE RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Uveitis (Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS), Medical device implantation, Post procedural complication and Hypersensitivity that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Uveitis was not resolved while rest of the events was resolved at the time of report. Relevant medical history remains a confounder to the event Uveitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a adult  female patient of unspecified age with relevant medical history of INTERMEDIATE, POSTERIOR AND PANUVEITIS MODERATE TO SEVERE RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Uveitis (Uveitis flare up / INCREASED SYMPTOMS WITH UVEITIS), Medical device implantation, Post procedural complication and Hypersensitivity that occurred on an unknown date in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Uveitis was not resolved while rest of the events was resolved at the time of report. Relevant medical history remains a confounder to the event Uveitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.