Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: mild to moderate vision loss; re-occurring sore throat; headache; severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain; severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain; extremely an active person and I can even barely walk anymore; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (mild to moderate vision loss) in a 65-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 DUPILUMAB solution for injection for Nasal polyps, Sinusitis and Asthma.    Concurrent medical conditions included Asthma, Sinusitis and Nasal polyps.   On 12-Feb-2021, the patient started DUPILUMAB (Subcutaneous) at an unspecified dose. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, DUPILUMAB (Subcutaneous) dosage was changed to 300 milligram, DUPILUMAB (Subcutaneous) dosage was changed to 300 milligram and DUPILUMAB (Subcutaneous) dosage was changed to 300 milligram. In March 2021, the patient experienced ARTHRALGIA (severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain) and MYALGIA (severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain). On 28-May-2021, the patient experienced BLINDNESS (mild to moderate vision loss) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (re-occurring sore throat) and HEADACHE (headache). In 2021, the patient experienced GAIT DISTURBANCE (extremely an active person and I can even barely walk anymore). At the time of the report, BLINDNESS (mild to moderate vision loss), OROPHARYNGEAL PAIN (re-occurring sore throat) and HEADACHE (headache) outcome was unknown and GAIT DISTURBANCE (extremely an active person and I can even barely walk anymore), ARTHRALGIA (severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain) and MYALGIA (severe joint pain in her knees, hips and lower back/ increasing significant muscle /joint pain) had not resolved.            Patient ID was reported.  Concomitant drugs were not reported.  Company causality was reportable for myalgia, arthralgia and gait disturbance and not reportable for other events.  Treatment medication 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 is a spontaneous case, reported by a patient, concerning a 65-year-old female patient with current medication of Dupilumab, who experienced the unexpected serious (medically significant) event of Blindness, described as mild to moderate vision loss, which occurred approximately 1 month and few weeks after receiving a dose of mRNA-1273 as the second dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccination). It was reported that the patient experienced joint and muscle pain in her knees, hips and lower back with significant increased of muscle and joint pain. Patient was then developed more severe muscle and joint pain in her knees, hips and lower back with increased in severity. Furthermore, patient also developed a mild to moderate vision loss and re-occurring sore throat and headaches. No further details about the diagnostic procedures and treatments were provided. Outcome of the event Blindness was unknown. The intake co-suspect drug Dupilumab may cause blepharitis, conjunctivitis, dry eyes, itching of eye, and keratitis, which may contribute to mild to moderate vision loss. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 65-year-old female patient with current medication of Dupilumab, who experienced the unexpected serious (medically significant) event of Blindness, described as mild to moderate vision loss, which occurred approximately 1 month and few weeks after receiving a dose of mRNA-1273 as the second dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccination). It was reported that the patient experienced joint and muscle pain in her knees, hips and lower back with significant increased of muscle and joint pain. Patient was then developed more severe muscle and joint pain in her knees, hips and lower back with increased in severity. Furthermore, patient also developed a mild to moderate vision loss and re-occurring sore throat and headaches. No further details about the diagnostic procedures and treatments were provided. Outcome of the event Blindness was unknown. The intake co-suspect drug Dupilumab may cause blepharitis, conjunctivitis, dry eyes, itching of eye, and keratitis, which may contribute to mild to moderate vision loss. The benefit-risk relationship of mRNA-1273 is not affected by this report.