Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Oxygen saturation decreased, Road traffic accident, SARS-CoV-2 test, Sleep apnoea syndrome
Clinical narrative: CATARACT IN LEFT EYE; Sleep apnea; OXYGEN LEVELS LOW; CAR ACCIDENT; This spontaneous case was reported by a patient and describes the occurrence of CATARACT (CATARACT IN LEFT EYE) in a 63-year-old male 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) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 on 06-Mar-2021 and Sickness from 06-Mar-2021 to April 2021. Concurrent medical conditions included Rheumatoid arthritis.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. On an unknown date, the patient experienced CATARACT (CATARACT IN LEFT EYE) (seriousness criterion medically significant), SLEEP APNOEA SYNDROME (Sleep apnea), OXYGEN SATURATION DECREASED (OXYGEN LEVELS LOW) and ROAD TRAFFIC ACCIDENT (CAR ACCIDENT). At the time of the report, CATARACT (CATARACT IN LEFT EYE), SLEEP APNOEA SYNDROME (Sleep apnea), OXYGEN SATURATION DECREASED (OXYGEN LEVELS LOW) and ROAD TRAFFIC ACCIDENT (CAR ACCIDENT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation decreased: Low. On an unknown date, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Sleep study: oxygen levels low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Patient was using sleep machine to diagnosis and help with sleep apnea.   He had cataract in left eye which blurred his vision, patient noticed thisafter car accident.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of CATARACT IN LEFT EYE, TESTED POSITIVE TO COVID-19, OXYGEN LEVELS LOW and SLEEP APNEA with HUMIRA was no reasonable possibility.   The reporter's causality for the event of SICK FROM COVID VACCINE with HUMIRA was a reasonable possibility.   The reporter's causality for the event of CAR ACCIDENT was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of CATARACT IN LEFT EYE, SICK FROM COVID VACCINE, TESTED POSITIVE TO COVID-19, OXYGEN LEVELS LOW, SLEEP APNEA and CAR ACCIDENT are related to HUMIRA.  Treatment details were not given.  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 63 year old male patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Cataract (reported as CATARACT IN LEFT EYE), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient met with a road traffic accident which was followed by blurry vision and cataract in the left eye. No information on detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63 year old male patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Cataract (reported as CATARACT IN LEFT EYE), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient met with a road traffic accident which was followed by blurry vision and cataract in the left eye. No information on detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.