Sex: M
Vaccine: COVID19
Symptoms: Thyroid stimulating immunoglobulin
Clinical narrative: TED symptoms significantly worsened with severe eye pain, eyelid edema, conjunctival erythema, worsening proptosis and diplopia, and swelling of the conjunctiva and caruncle (CAS 7/10); TED symptoms significantly worsened with severe eye pain, eyelid edema, conjunctival erythema, worsening proptosis and diplopia, and swelling of the conjunctiva and caruncle (CAS 7/10); This is a literature report.  A 50-year-old non-smoker male, with a history of psoriasis, vitiligo, and atrophic gastritis, was diagnosed with GD 14 in March 2019 and treated with methimazole. In April 2020, he developed TED with bilateral proptosis, pain, 15 edema, and diplopia. His CAS was 6/7. Following a 3-month course of oral methylprednisolone, at a dose of 48 mg 16 per day, he showed limited response and developed severe side effects. He underwent total thyroidectomy in 17 November 2020. Six weeks after the operation, his TED improved (CAS 4/10), without significant improvement in 18 proptosis, thyroglobulin was low at 3.09 ng/ml, and thyroid stimulated immunoglobulin (TSI) levels normalized 19 from 4.13 IU/l six weeks prior to surgery to 0.70 IU/l (reference< 1.75 IU/l). In January 2021, he received 2 doses of 20 the mRNA BNT162b2-SARS-CoV-2 vaccine (Pfizer-BioNTech). Three weeks after the second dose, his TED 21 symptoms significantly worsened with severe eye pain, eyelid edema, conjunctival erythema, worsening proptosis 22 and diplopia, and swelling of the conjunctiva and caruncle (CAS 7/10) (Fig. 1A). TSI levels rose to 4.45 IU/l, while 23 patient was euthyroid on levothyroxine (TSH 2.3 mIU/L). He received 12 weekly methylprednisolone infusions 24 (cumulative dose of 4.5 g) with limited response. He was then treated with three monthly cycles of intravenous 25 tocilizumab with remission of inflammation of caruncle, but otherwise limited improvement in eyelid swelling and 26 pain, and no effect on proptosis and diplopia (CAS 6/10). Severe arthralgias and intractable pruritus necessitated discontinuation of tocilizumab treatment. The patient then received a full course of treatment with teprotumumab, 1 with 8 infusions at 3-week intervals. Significant clinical improvement was noted after the third teprotumumab 2 infusion, leading to an excellent overall response over a 24-week period, as evidenced by significant decrease in 3 eyelid swelling/pain, improvement in diplopia, and decreased CAS score from 6/10 to 3/10, in view of 5 mm 4 improvement in proptosis and resolution of conjunctival redness and swelling.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Thyroid eye disease, Condition worsened and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.