Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Optical coherence tomography, Pericarditis, Rash pustular, Red blood cell sedimentation rate
Clinical narrative: Cataracts in setting of multisystem inflammation after COVID-19 vaccination; pericarditis; pericarditis with cardiac tamponade; pulmonary capillary leak; bilateral sensorineural hearing loss; bilateral ischemic cerebellar cerebral vascular accidents; hematuria; nausea; emesis; myalgias; abdominal pain; diffuse pustular rash; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s).  A 20-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (hospitalization) with onset 2021, 2 days after the suspect product(s) administration, outcome "unknown"; RASH PUSTULAR (hospitalization) with onset 2021, 2 days after the suspect product(s) administration, outcome "unknown", described as "diffuse pustular rash"; VOMITING (hospitalization) with onset 2021, 2 days after the suspect product(s) administration, outcome "unknown", described as "emesis"; MYALGIA (hospitalization) with onset 2021, 2 days after the suspect product(s) administration, outcome "unknown", described as "myalgias"; NAUSEA (hospitalization) with onset 2021, 2 days after the suspect product(s) administration, outcome "unknown"; CATARACT (hospitalization, medically significant), outcome "unknown", described as "Cataracts in setting of multisystem inflammation after COVID-19 vaccination"; PERICARDITIS (hospitalization, medically significant), outcome "unknown"; CARDIAC TAMPONADE (hospitalization, medically significant), outcome "unknown", described as "pericarditis with cardiac tamponade"; CAPILLARY LEAK SYNDROME (hospitalization, medically significant), outcome "unknown", described as "pulmonary capillary leak"; DEAFNESS NEUROSENSORY (hospitalization, medically significant), outcome "unknown", described as "bilateral sensorineural hearing loss"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "bilateral ischemic cerebellar cerebral vascular accidents"; HAEMATURIA (hospitalization), 2 days after the suspect product(s) administration, outcome "unknown", described as "hematuria". The patient underwent the following laboratory tests and procedures: Antibody test: negative; negative; negative; negative; negative; Antineutrophil cytoplasmic antibody: negative; Blood lactate dehydrogenase: elevated; Chemokine test: elevated; C-reactive protein: elevated; IL-2 receptor assay: elevated; Inflammatory marker test: his hospital course, he remained without anterior, notes: anterior chamber cells, high intraocular pressure, vitreous cells, disc edema, and other signs of inflammatory findings; Interleukin level: elevated; elevated; elevated; Evaluation for malignancy: negative; leukocytosis and acute kidney injury; negative; Exam: was notable for a, notes: pustular rash on his face and torso and VA of 20/20, mild conjunctival chemosis and trace follicular reaction in both eyes; notable for a systemic dysregulated, notes: inflammatory process including elevated C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase, and lymphopenia; Lymphocyte count: elevated; Ophthalmological examination: revealed resolving chemosis, notes: On day two conjunctivitis with resolution of subjective blurriness; revealed bilateral mild anterior, notes: and posterior subcapsular lens opacities radiating centrally; Optical coherence tomography: RNFL and macula were normal; Red blood cell sedimentation rate: elevated; Rheumatoid factor: negative; SARS-CoV-2 antibody test: Negative; SARS-CoV-2 test: Negative, notes: during admission; Visual acuity tests: 20/25; was J1 plus bilaterally; 20/300, notes: in the right eye At month 3. lenses were intumescent with dense opacities radiating from the center and multiple scattered punctate opacities; 20/400, notes: in the left eye At month 3. lenses were intumescent with dense opacities radiating from the center and multiple scattered punctate opacities; 20/25, notes: At post-op month 1, each eye had best corrected; 20/20. Therapeutic measures were taken as a result of cataract, pericarditis, cardiac tamponade, capillary leak syndrome, deafness neurosensory, cerebrovascular accident.  Clinical course: In Apr2021, a 20-year-old male college student with no medical history presented to the emergency department for evaluation of new onset nausea, emesis, myalgias, abdominal pain, hematuria, and a diffuse pustular rash two days after receiving the first dose of the BNT162b2 COVID-19 vaccine. At the time of presentation, he endorsed new bilateral eye redness and mild blurriness that began that day. His exam was notable for a pustular rash on his face and torso and VA of 20/20, mild conjunctival chemosis and trace follicular reaction in both eyes. His initial laboratory evaluation showed. He was started on empiric steroids for a presumed inflammatory reaction related to the mRNA COVID-19 vaccination. On day two, ophthalmic exam revealed resolving chemosis and conjunctivitis with resolution of subjective blurriness. Artificial tears as needed for comfort were recommended. Two weeks later, patient began to experience bilateral blurriness worse at distance. His visual acuity was J1 bilaterally and slit lamp exam revealed bilateral mild anterior and posterior subcapsular lens opacities radiating centrally. By this time, his hospital course had been complicated by numerous systemic events felt to be related to a vaccination-related hyper-inflammatory state, including pericarditis with cardiac tamponade requiring pericardiocentesis, pulmonary capillary leak, bilateral sensorineural hearing loss, and bilateral ischemic cerebellar cerebral vascular accidents. He was treated with two rounds of IVIG and pulse-dose steroids for three days and slowly tapered. While steroids were risk factors for cataract development, they were continued as the benefits of systemic immunosuppression outweighed the visual risks. His cataracts continued to progress during admission while on a slow steroid taper. At month 3, his best corrected VA was 20/300 in the right eye and 20/400 in the left eye, lenses were intumescent with dense opacities radiating from the center and multiple scattered punctate opacities. OCT RNFL and macula were normal. During his hospital course, he remained without anterior chamber cells, high intraocular pressure, vitreous cells, disc edema, and other signs of inflammatory findings. Given the visual significance and continued progression of cataracts, cataract extraction with hacoemulsification with an intraocular multifocal lens implantation was performed bilaterally two weeks apart. At post op month 1, each eye had best corrected visual acuity 20/25. Patient was transferred to inpatient rehabilitation after month 3 to focus on regaining functional mobility. Laboratory diagnostic evaluation was performed during admission was notable for a systemic dysregulated inflammatory process, including elevated C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase, and lymphopenia. Evaluation for malignancy was negative. He had a negative serum COVID-19 IgG and multiple negative COVID-19 PCR tests during admission, which ruled out a prior COVID-19 infection. He was negative for all other infectious work-up. EXtensive autoimmune and genetic panel was notable for elevated IL- 2, IL-10, IL-13, IL-6, and C-X-C Motif Chemokine Ligand 9 (CXCL9). He was negative for all other autoimmune markers including antinu-clear antibodies, anticardolipin antibody, antineutrophil cytoplasmic antibodies, anti-scl-70 antibodies, rheumatoid factor, SS-A antibodies, and SS-B antibodies.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.