Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Computerised tomogram, Diplopia, Double stranded DNA antibody
Clinical narrative: inflammation of the left superior oblique muscle/ documenting orbital myositis and dacryoadenitis following the covid-19 vaccination; The OS was noted to have marked limitation in supraduction and 3 mm of relative proptosis; Orbital Inflammation Following COVID-19 Vaccination; Binocular diplopia; pain with extraocular movements; periorbital swelling; The OS was noted to have marked limitation in supraduction and 3 mm of relative proptosis; mild left-sided periorbital edema and erythema with limitation of supraduction; mild left-sided periorbital edema and erythema with limitation of supraduction; This is a literature report.  The authors report 3 cases of orbital inflammation occurring within days of the BNT162b2 mRNA (Pfizer/BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccine which is suggestive of an association.  A 68-year-old man with no known autoimmune or rheumatologic history presented with binocular diplopia, pain with extraocular movements, and periorbital swelling 4 days after receiving the second dose of COVID-19 vaccine (BNT162b2 mRNA, Pfizer/BioNTech). He denied any other systemic infectious or inflammatory symptoms. On presentation, his visual acuity was 20/20 in each eye and intraocular pressures (IOP) were normal. There was no relative afferent pupillary defect (rAPD) or dyschromatopsia. The OS was noted to have marked limitation in supraduction and 3 mm of relative proptosis (External photograph demonstrating mild left-sided periorbital edema and erythema with limitation of supraduction). The remainder of his ophthalmic examination was unremarkable. Orbital CT with contrast revealed inflammation of the left superior oblique muscle (CT orbits with contrast, coronal (left) and axial (right) sections demonstrating focal enlargement of the anterior aspect of the left superior oblique muscle (arrows).). A laboratory workup including complete blood count (CBC), basic metabolic panel (BMP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), angiotensin-converting enzyme (ACE), lysozyme, IgG subclass, antinuclear antibody (ANA), antineutrophil cytoplastmic antibody (ANCA), double-stranded DNA antibody (DS-DNA), thyroid-stimulating hormone (TSH) with reflex, Sjogren's antibodies (SS-A/SS-B), rheumatoid factor (RF), quantiferon-gold, fluorescent treponemal antibody-absorption (FTA-ABS), rapid plasma reagin (RPR), and Epstein Barr virus antibodies (EBV) was unremarkable.  In all 3 cases, an extensive infectious and inflammatory laboratory work-up was unremarkable. Signs and symptoms of orbital inflammation improved promptly in all cases after initiation of treatment with 60 mg of oral prednisone. All patients achieved complete resolution after prednisone taper over the span of 1 month and have remained in remission at 6 to 11 months follow-up after completion of treatment.  [Discussion] This is the first report documenting orbital myositis and dacryoadenitis following the COVID-19 vaccination. The onset of symptoms within 1 week of vaccination is in line with previous literature. The exact immune-mediated mechanism by which COVID-19 targets orbital tissue remains yet to be elucidated. However, inflammation following vaccination suggests an immunological process targeting orbital tissue rather than direct viral infiltration, which has been hypothesized by some to be the underlying mechanism of COVID-19 infection-associated ophthalmic diseases. Although rare, orbital myositis or dacryoadenitis may occur within days after administration of the COVID-19 vaccine. If no underlying etiology is identified after extensive workup, an inflammatory postvaccine etiology may be considered as an alternative to a presumed idiopathic diagnosis. As in 2 of the 3 reported cases, a history of orbital inflammation may be a predisposing factor. Though causation cannot be proven, the temporal relationship between vaccination and onset of orbital inflammatory symptoms in the reported cases, in combination with an extensive unrevealing workup, is highly suggestive of an association. Ophthalmologists should be aware of this possible association to appropriately counsel patients, particularly those with underlying orbital inflammatory conditions, of signs and symptoms that may warrant early examination. Prophylactic treatment with corticosteroid prior to vaccination may be considered for patients with previous orbital inflammation. However, it remains yet to be elucidated whether such treatment may diminish vaccine efficacy.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200506816 Same drug/event and different patient