Sex: F
Vaccine: COVID19
Symptoms: Investigation, Laboratory test, Lumbar puncture, Lyme disease, Magnetic resonance imaging head
Clinical narrative: evolving to fulminant IH in a healthy female after receiving the SARS-CoV-2 vaccine; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (UNKNOWN MANUFACTUR)), for COVID-19 Immunization. The following information was reported: INTRACRANIAL PRESSURE INCREASED (hospitalization, medically significant), 7 days after the suspect product(s) administration, outcome "recovering", described as "evolving to fulminant IH in a healthy female after receiving the SARS-CoV-2 vaccine". The event "evolving to fulminant ih in a healthy female after receiving the sars-cov-2 vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Bartonella test: unknown result; Blood glucose: 64; 107, notes: again; Body mass index: 28, notes: stable, Unit: kg/m2; Computerised tomogram head: partially empty sella, notes: Bilateral optic disc edema; Computerised tomogram venography head: normal, notes: With patent superior sagittal and transverse sinuses; C-reactive protein: unknown result; CSF cell count: unremarkable; unremarkable; CSF culture: unknown result; Enterovirus test: unknown result; Full blood count: unknown result; Fundoscopy: noted bilateral grade-3 edema; Fungal test: unknown result; HIV test: unknown result; Inflammatory marker test: Unknown result; were unremarkable; Arbovirus Abs: unknown result; unknown result; unknown result; unknown result; unknown result; were unremarkable; Examination: was only notable for  left incomplete, notes: sixth nerve palsy; Lumbar puncture: opening pressure of 26 cm; opening pressure of 51 cm, notes: H2O, with a closing pressure of 11 cm H2Oafter 35 mL of CSF removed; Lyme disease: unknown result; Magnetic resonance imaging head: partially empty sella, notes: which was also seen on CT head abs bilateral optic disc edema; orbits was stable compared with prior imaging; Metabolic function test: Unknown results; Mycoplasma test: Unknown result; Polymerase chain reaction: Unknown result; Procalcitonin: unknown result; Protein total: 20; 35, notes: again; Red blood cell count: 4; 4, notes: again; Red blood cell sedimentation rate: unknown result; SARS-CoV-2 antibody test: unknown result; unknown result; Toxoplasmosis: unknown result; unknown result; Treponema test: unknown result; unknown result; Venogram: normal with patent superior sagittal and, notes: transverse sinuses; Visual acuity tests: 20/20, notes: right; 20/25, notes: left; no light perception, notes: Right eye; counting fingers intact at 1 inch, notes: Left eye; 20/150, notes: 4 days later; White blood cell count: 1; 1, notes: again. Therapeutic measures were taken as a result of intracranial pressure increased. Clinical course: tinnitus with pulsatile features; 1 week of bilateral frontal headache, neck pain, and daily vomiting; and 2 days of blurred vision and photophobia, right worse than left. The pulsatile tinnitus had begun 11 weeks prior but was intermittent, accompanied by weekly, mild headaches. Onset coincided with her second severe acute respiratory syndrome-coronavirus-2 (SARSCoV- 2) vaccination (Pfizer-BioNTech; dosage same as adults given age>12 years), given approximately 7 days before the initial onset of symptoms. She had started taking ketorolac and ibuprofen, without effect, prescribed by an outside facility for a diagnosis of migraine and torticollis. At presentation to ER, her examination was only notable for a left, incomplete sixth nerve palsy; visual acuity was 20/20 on the right, 20/25 on the left. Visual fields were full to confrontation in each eye though perimetry was not performed. Funduscopic examination noted bilateral grade-3 edema (Fig. 1A, B: Images obtained from funduscopic examination within the ER demonstrating grade three optic disc edema with retinal nerve fiber layer opacification (arrowheads), nerve fiber layers hemorrhages (flame hemorrhages, arrow), and cotton wool spots (circled) in each eye.). A computed tomography (CT) venogram of the head was normal with patent superior sagittal and transverse sinuses (Fig. 2B, C: Sagittal CT venography showed normal appearance of dural venous sinuses with no evidence of dural sinus venous thrombosis.); magnetic resonance imaging (MRI) of the brain revealed a partially empty sella which was also seen on CT head (Fig. 2A, B: Sagittal CT image show a partial empty sella (arrow) with a small, flattened pituitary gland along the floor of the sella turcica; this can also be seen on the follow up MRI) and bilateral optic disc edema (Fig. 2D, E: Axial T2-weighted and axial contrast-enhanced fatsaturated T1-weighted MRI images show posterior flattening of the eye globes at the insertion site of the optic nerves bilaterally with prominence of the optic nerves/retina at the junction with the globes bilaterally (white arrows) and dilated optic nerve sheaths (yellow arrows). CT, computed tomography; MRI, magnetic resonance imaging.). A lumbar puncture (LP) in the lateral decubitus position showed an opening pressure of 26 cm H2O and closing of 8 cm H2O after 11mL of cerebral spinal fluid (CSF) was removed. CSF studies were unremarkable (white blood cell [WBC]=1, red blood cell [RBC]=4, protein =20, and glucose=64) as were systemic inflammatory markers. She was not on any medications, had no recent travel history, upper respiratory symptoms, or changes in weight with a stable body mass index (BMI) of 28 kg/m2. Thus, she was presumed to have primary intracranial hypertension (IH; colloquially and idiopathic IH) and discharged on acetazolamide 500mg by mouth twice daily. The patient was urgently seen by ophthalmology 4 days after discharge with complaints of rapidly worsening visual loss. In the office, she was found to have grade-3 optic disc edema with cotton-wool spots and small-flame hemorrhages bilaterally (Fig. 1C, D: Images from funduscopic examination obtained 3 days later in the setting of acute worsening of vision. Images again demonstrate marked optic disc edema (arrowheads), cotton wool spots (circles), and rare flame hemorrhages (arrows). ER, emergency room.). She now had bilateral and complete sixth cranial nerve palsies, as well as bilateral adduction deficits and a right afferent pupillary defect (APD). Vertical gaze was intact but restricted. We interpreted these additional findings as a fourth cranial nerve palsy which has been shown to rarely occur in primary IH and may cause mild exotropia and/or vertical preference on primary gaze; the former of which was absent because of concomitant sixth cranial nerve palsy. Visual acuity on the right eye was "no light perception," the left was "counting fingers" intact at 1 inch. She was sent to the ER where she also endorsed worsened neck stiffness and eye pain. There, a repeat MRI brain and orbits was stable compared with prior imaging. Infectious disease (ID) and neurology were consulted. A repeat LP showed an opening pressure of 51 cm H2O, with a closing pressure of 11 cm H2O after 35mL of CSF was removed. CSF studies were, again, unremarkable (WBC =1, RBC=4, protein=35, and glucose=107). General serum studies and inflammatory markers, as well as serum and CSF infectious studies, were unremarkable. Given the CSF findings and MRI, there was no evidence of optic neuritis (ON) or other inflammatory process. The day following the LP she endorsed mild improvement in right eye vision. She went for placement of a ventriculoperitoneal (VP) shunt that afternoon and was discharged the next day on acetazolamide of 1,000mg by mouth twice daily and close follow-up. Four days later, she had marked improvement of sixth cranial nerve palsies and visual acuity in the left eye (20/150). Her disc edema was absent (though disc now pale) at ophthalmology follow-up 5 weeks later.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event INTRACRANIAL PRESSURE INCREASED  and the suspect drug BNT162B2 cannot be excluded. 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.