Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blindness, Cough, Eyelid ptosis, Nervous system disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (VISION LOSS) and UVEITIS (NON-INFECTIOUS INTERMEDIATE, POSTERIOR AND PANUVEITIS FLARE UP) in an adult 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. Previously administered products included for Pneumonia: Pneumonia vaccine in September 2021; for Flu: flu vaccine in September 2021. Past adverse reactions to the above products included No adverse reaction with Pneumonia vaccine and flu vaccine. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second 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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced BLINDNESS (VISION LOSS) (seriousness criterion medically significant), UVEITIS (NON-INFECTIOUS INTERMEDIATE, POSTERIOR AND PANUVEITIS FLARE UP) (seriousness criterion medically significant), EYELID PTOSIS (NERVE DAMAGE ON RIGHT EYE LID), NERVOUS SYSTEM DISORDER (UNCURBABLE NERVE DISORDER), VACCINATION SITE HYPERAESTHESIA (ARM SENSITIVE TO PRESSURE AFTER COVID-19 VACCINE), COUGH (COUGHING), STRESS (STRESSED), PAIN (SORENESS) and ARTHRALGIA (FELT ACHY JOINTS). At the time of the report, BLINDNESS (VISION LOSS), EYELID PTOSIS (NERVE DAMAGE ON RIGHT EYE LID), VACCINATION SITE HYPERAESTHESIA (ARM SENSITIVE TO PRESSURE AFTER COVID-19 VACCINE), COUGH (COUGHING), STRESS (STRESSED), PAIN (SORENESS) and ARTHRALGIA (FELT ACHY JOINTS) outcome was unknown and UVEITIS (NON-INFECTIOUS INTERMEDIATE, POSTERIOR AND PANUVEITIS FLARE UP) and NERVOUS SYSTEM DISORDER (UNCURBABLE NERVE DISORDER) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. The patient reported that she had arm sensitive to pressure after receiving the Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She had arm sensitive to pressure after receiving the Moderna vaccine and was using inhaler more often. She had Pneumonia and flu shot in Sep 2021. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. No treatment medication 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. Company comment: This spontaneous case concerns an adult, female patient with relevant medical history of Non-infectious Intermediate, Posterior and Panuveitis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of blindness and uveitis flare-up, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced vision loss, nerve damage on the right eyelid, incurable nerve disorder (unspecified), arm sensitive to pressure, coughing, stress, achy joints, soreness, and Non-infectious Intermediate, Posterior and Panuveitis flare-up. Treatment information was not provided. The medical history of Non-infectious Intermediate, Posterior and Panuveitis remains a confounder for the event uveitis flare-up. The co-suspect product Humira also remains a confounder for the event uveitis flare-up. Of note, Uveitis may be a contributing factor for the event blindness since permanent vision loss is a possible complication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Significant Live follow up appended: Updated new events COUGHING, STRESSED, FELT ACHY JOINTS, SORENESS and Pneumonia, dose of Humira with lot number, start date of first dose of Moderna changed to 19-APR-2021 and start date of second dose Moderna to 21-MAY-2021, updated outcome of events vision loss and ptosis of eyelid to unknown and clinical related information. Sender's Comments: This spontaneous case concerns an adult, female patient with relevant medical history of Non-infectious Intermediate, Posterior and Panuveitis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of blindness and uveitis flare-up, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced vision loss, nerve damage on the right eyelid, incurable nerve disorder (unspecified), arm sensitive to pressure, coughing, stress, achy joints, soreness, and Non-infectious Intermediate, Posterior and Panuveitis flare-up. Treatment information was not provided. The medical history of Non-infectious Intermediate, Posterior and Panuveitis remains a confounder for the event uveitis flare-up. The co-suspect product Humira also remains a confounder for the event uveitis flare-up. Of note, Uveitis may be a contributing factor for the event blindness since permanent vision loss is a possible complication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.