Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Ophthalmological examination, Optical coherence tomography, Pain assessment, Red blood cell sedimentation rate
Clinical narrative: MEWDS-like presentation two weeks after a fever illness and two days after administration of the SARS-CoV-2 vaccine; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "significant for migraine" (unspecified if ongoing); "daily fevers", start date: 30Mar2021 (unspecified if ongoing), notes: for 3 days. The patient's concomitant medications were not reported. The following information was reported: RETINAL WHITE DOTS SYNDROME (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "MEWDS-like presentation two weeks after a fever illness and two days after administration of the SARS-CoV-2 vaccine". The patient underwent the following laboratory tests and procedures: Angiogram retina: (unspecified date) showed severe leakage from the disc in the, notes: right eye with, mild leakage from the disc in the left eye, and wreath-like choroidal hyperfluorescence of the posterior pole in both eyes; Antibody test: (unspecified date) Pertinent negative; Antineutrophil cytoplasmic antibody: (unspecified date) Pertinent negative; Antinuclear antibody: (unspecified date) Pertinent negative; Blood culture: (unspecified date) Pertinent negative; Blood immunoglobulin G: (unspecified date) Pertinent negative; Blood immunoglobulin M: (unspecified date) 1.07, notes: reference: less than 0.89 IV; Body temperature: (30Mar2021) ranging from 101.4  to 102 ).; C-reactive protein: (unspecified date) Pertinent negative; Cryptococcus test: (unspecified date) Pertinent negative; CSF glucose (40-70): (unspecified date) 56 mg/dl; CSF protein (15-45): (unspecified date) 23 mg/dl; CSF volume: (unspecified date) elevated; Cytomegalovirus test: (unspecified date) Positive, notes: the patient had no clinical evidence for ocular or systemic CMV; HIV test: (unspecified date) Pertinent negative; Inflammatory marker test: (unspecified date) normal; routine infectious: (unspecified date) normal; Borrelia burgdorferi antibody: (unspecified date) Pertinent negative; (unspecified date) Pertinent negative; (unspecified date) 1/2; Lumbar puncture: (unspecified date) showed elevated opening pressure and cerebrospinal, notes: pleocytosis consistent with an aseptic meningitis; (unspecified date) showed elevated opening pressure of 55 cm H2O, notes: (reference: less than 20cmH2O); Magnetic resonance imaging head: (unspecified date) showed minimal papilledema but was otherwise norma; Neurological examination: (unspecified date) normal; Ophthalmological examination: (unspecified date) Ophthalmoscopy showed bilateral optic disc edema,, notes: a peripapillary hemorrhage, and multifocal, well-circumscribed, deep, chorioretinal white lesions in the periphery OU; (unspecified date) showed optic disc edema in both eyes (OU) and, notes: multifocal well-circumscribed chorioretinal white lesions in the periphery OU; (unspecified date) vision was 20/20 in both eyes with correction,, notes: extraocular movements were full, and the slit lamp exam was normal; (unspecified date) 20/20, notes: One month after discharge resolution of the optic disc edema and peripapillary flame hemorrhage; Optical coherence tomography: (unspecified date) showed resolution of the optic nerve edema OU, notes: One month after discharge; Pain assessment: (unspecified date) 8 out of 10, notes: severe headaches; Red blood cell sedimentation rate (0-20): (unspecified date) 30, notes: Units: mm/hour; Rheumatoid factor: (unspecified date) Pertinent negative; SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; Slit-lamp examination: (unspecified date) Normal; Treponema test: (unspecified date) Pertinent negative; White blood cell count: (unspecified date) 48 cells/uL. Therapeutic measures were taken as a result of retinal white dots syndrome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Retinal white dots syndrome" and the suspect drug BNT162B2 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.