Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Dry eye, Eye haemorrhage, Procedural complication
Clinical narrative: LEFT EYE CATARACT/RIGHT EYE CATARACT; BROKEN BLOOD VESSLES IN EYES; RIGHT EYE MUSCLE STARTED TO SHRED DURING SURGERY; DRY EYES; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (LEFT EYE CATARACT/RIGHT EYE CATARACT) and EYE HAEMORRHAGE (BROKEN BLOOD VESSLES IN EYES) in a 48-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 ADALIMUMAB (HUMIRA) for Panuveitis and Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Uveitis.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced DRY EYE (DRY EYES). On 24-Aug-2021, the patient experienced PROCEDURAL COMPLICATION (RIGHT EYE MUSCLE STARTED TO SHRED DURING SURGERY). On an unknown date, the patient experienced CATARACT (LEFT EYE CATARACT/RIGHT EYE CATARACT) (seriousness criterion medically significant) and EYE HAEMORRHAGE (BROKEN BLOOD VESSLES IN EYES) (seriousness criterion medically significant). At the time of the report, CATARACT (LEFT EYE CATARACT/RIGHT EYE CATARACT) and EYE HAEMORRHAGE (BROKEN BLOOD VESSLES IN EYES) outcome was unknown, DRY EYE (DRY EYES) had not resolved and PROCEDURAL COMPLICATION (RIGHT EYE MUSCLE STARTED TO SHRED DURING SURGERY) had resolved. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant product use was reported.  The patient received all doses one in once. Humira (Adalimumab) was citrate free.  On 03-Aug-2021, the patient had surgery on left eye and on 24-Aug-2021, right eye cataract surgery. The Right eye muscle shred during surgery but was able to put back together. One or times a month she gets broken blood vessels in eyes. Doctor said it was because of weak blood vessels.  No drug treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the events of left eye cataract, right eye cataract, right eye muscle started to shred during surgery, dry eyes and broken blood vessels in eyes was not 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.  Company comment: This spontaneous case concerns a 48-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) events of cataract and eye haemorrhage an unknown time after the booster dose of mRNA-1273. The medical history uveitis, as well as cataract surgery, could be confounders for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) events of cataract and eye haemorrhage an unknown time after the booster dose of mRNA-1273. The medical history uveitis, as well as cataract surgery, could be confounders for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.