Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood thyroid stimulating hormone
Clinical narrative: Orbital Inflammation; binocular diplopia; periorbital swelling; pain with extraocular movements; mild myalgias; headache; This literature-non-study case was reported in a literature article and describes the occurrence of PERIORBITAL INFLAMMATION (Orbital Inflammation) in a 33-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.      The patient's past medical history included Periorbital inflammation. Previously administered products included for Product used for unknown indication: influenza vaccination (Patient had a previous similar episode of orbital inflammation 1 day following an influenza vaccination 1 year prior). Past adverse reactions to the above products included Periorbital inflammation with influenza vaccination.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIORBITAL INFLAMMATION (Orbital Inflammation) (seriousness criterion medically significant), DIPLOPIA (binocular diplopia), PERIORBITAL SWELLING (periorbital swelling), EYE PAIN (pain with extraocular movements), MYALGIA (mild myalgias) and HEADACHE (headache). The patient was treated with PREDNISONE (oral) for Periorbital inflammation, at a dose of 60 milligram and PREDNISONE for Periorbital inflammation, at a dose of UNK, taper dose. At the time of the report, PERIORBITAL INFLAMMATION (Orbital Inflammation), DIPLOPIA (binocular diplopia), PERIORBITAL SWELLING (periorbital swelling), EYE PAIN (pain with extraocular movements), MYALGIA (mild myalgias) and HEADACHE (headache) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiotensin converting enzyme: unremarkable Unremarkable. On an unknown date, Antibody test: unremarkable Unremarkable. On an unknown date, Antineutrophil cytoplasmic antibody: unremarkable Unremarkable. On an unknown date, Antinuclear antibody: unremarkable Unremarkable. On an unknown date, Blood thyroid stimulating hormone: unremarkable Unremarkable. On an unknown date, Borrelia test: unremarkable Unremarkable. On an unknown date, C-reactive protein: unremarkable Unremarkable. On an unknown date, DNA antibody: unremarkable Unremarkable. On an unknown date, Epstein-Barr virus antibody: unremarkable Unremarkable. On an unknown date, Full blood count: unremarkable Unremarkable. On an unknown date, Intraocular pressure test: normal (normal) Normal. On an unknown date, Lysozyme: unremarkable Unremarkable. On an unknown date, Magnetic resonance imaging: inflammation and enlargement MRI of the orbits with contrast revealed inflammation and enlargement of the left medial and lateral rectus,  and superior oblique muscles. On an unknown date, Metabolic function test: unremarkable Unremarkable. On an unknown date, Ophthalmic scan: unremarkable unremarkable. On an unknown date, Red blood cell sedimentation rate: unremarkable Unremarkable. On an unknown date, Selective IgG subclass deficiency: unremarkable Unremarkable. On an unknown date, Treponema test: unremarkable Unremarkable. On an unknown date, Visual acuity tests: 20/15 in each eye 20/15 in each eye.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERIORBITAL INFLAMMATION (Orbital Inflammation), DIPLOPIA (binocular diplopia), PERIORBITAL SWELLING (periorbital swelling), EYE PAIN (pain with extraocular movements), MYALGIA (mild myalgias) and HEADACHE (headache) to be related.    Concomitant medications were not provided.  Patient was previously treated for a similar episode of orbital inflammation by an outside physician with a high dose oral corticosteroid to complete resolution after an unrevealing extensive lab workup.  All patients had a normal afferent function, unilateral limitation of extraocular motility, proptosis, and periorbita inflammation.  Signs and symptoms of orbital inflammation improved promptly after treatment.  Patient achieved complete resolution after prednisone taper over the span of 1 month and have remained in remission at 611 months follow-up after completion of treatment.  Laboratory tests included RF, Infectious and inflammatory laboratory test which were unremarkable.  Company comment: This is a Literature non study case concerning a 33-year-old female patient with history of previous similar episode of orbital inflammation 1 day following an influenza vaccination, 1 year prior, who experienced the unexpected serious (Medically significant) event of Periorbital Inflammation unknown days after the administration of the second dose of mRNA1273 vaccine along with other non serious events of diplopia, periorbital swelling, eye pain and headache ( onset dates were not provided). Lab tests were unremarkable. Magnetic resonance imaging showed inflammation and enlargement, MRI of the orbits with contrast revealed inflammation and enlargement of the left medial and lateral rectus, and superior oblique muscles. Ophthalmic scan was unremarkable.  The reporter considered the events to be related to Moderna Covid 19 vaccine. Patient was previously  with a high dose oral corticosteroid to complete resolution after an unrevealing extensive lab workup. Signs and symptoms of orbital inflammation improved promptly after treatment with complete resolution after prednisone. Previous history of orbital inflammation remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a Literature non study case concerning a 33-year-old female patient with history of previous similar episode of orbital inflammation 1 day following an influenza vaccination, 1 year prior, who experienced the unexpected serious (Medically significant) event of Periorbital Inflammation unknown days after the administration of the second dose of mRNA1273 vaccine along with other non serious events of diplopia, periorbital swelling, eye pain and headache ( onset dates were not provided). Lab tests were unremarkable. Magnetic resonance imaging showed inflammation and enlargement, MRI of the orbits with contrast revealed inflammation and enlargement of the left medial and lateral rectus, and superior oblique muscles. Ophthalmic scan was unremarkable.  The reporter considered the events to be related to Moderna Covid 19 vaccine. Patient was previously treated  with a high dose oral corticosteroid to complete resolution after an unrevealing extensive lab workup. Signs and symptoms of orbital inflammation improved promptly after treatment with complete resolution after prednisone. Previous history of orbital inflammation remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.