Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: IVth nerve paralysis, Magnetic resonance imaging, Neck pain
Clinical narrative: 4th nerve palsy in right eye; neck pain; This spontaneous case was reported by a patient and describes the occurrence of IVTH NERVE PARALYSIS (4th nerve palsy in right eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced IVTH NERVE PARALYSIS (4th nerve palsy in right eye) (seriousness criterion medically significant) and NECK PAIN (neck pain). The patient was treated with Physical therapy (physical therapy for her muscles in the eyes) for IVth nerve paralysis. In October 2021, NECK PAIN (neck pain) had resolved. At the time of the report, IVTH NERVE PARALYSIS (4th nerve palsy in right eye) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: diagnosed with 4th nerve palsy in right eye.         After first dose patient did not experience any symptoms. One week after second dose, patient noticed she was having trouble with her glasses because she was having double vision, and she also felt neck pain. She visited to her eye doctor first but after a while she visited to her primary care physician doctor referred her to a neurologist. Doctors thought it might be due to the vaccine, and made a battery of tests and 2 MRIs, and she was diagnosed with 4th nerve palsy in right eye. In Oct 2021 doctors recommended prisms in her new eyeglasses, and neck pain stopped, but double vision was still ongoing, and she had to close one eye when looking to the left to avoid double vision. After first booster, double vision was the same, and no additional symptoms appeared. Doctors recommended physical therapy for her muscles in the eyes.  No treatment medication was provided.  Company comment: This is a spontaneous case concerning a 60-year-old female patient with no reported medical history, on treatment with estradiol for an unknown indication,  who experienced the serious (medically significant) unexpected event 4th nerve paralysis, that started 7 days after the second dose of mRNA-1273.  Patient visits eye doctor and neurologist due to double vision and neck pain. Unspecified diagnostic test and MRI were performed and was diagnosed with 4th nerve palsy in right eye. Prescribed treatment included prisms in the eyeglasses and physical therapy for eye´s muscles. At the time of the report event had not resolved. Events seriousness captured as per IME list and medical judgement. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-636037 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 60-year-old female patient with no reported medical history, on treatment with estradiol for an unknown indication,  who experienced the serious (medically significant) unexpected event 4th nerve paralysis, that started 7 days after the second dose of mRNA-1273.  Patient visits eye doctor and neurologist due to double vision and neck pain. Unspecified diagnostic test and MRI were performed and was diagnosed with 4th nerve palsy in right eye. Prescribed treatment included prisms in the eyeglasses and physical therapy for eye´s muscles. At the time of the report event had not resolved. Events seriousness captured as per IME list and medical judgement. The benefit-risk relationship of mRNA-1273 is not affected by this report.