Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovitaminosis, Idiopathic intracranial hypertension, Lumbar puncture, Magnetic resonance imaging, Migraine
Clinical narrative: vision loss; hearing loss; vitamin deficiencies; memory loss; migraines daily; light sensitivity; tinnitus; overall poor quality of life now; vision problems/ everything was blurry, hot pink, with tracers; vision problems/ everything was blurry, hot pink, with tracers; vision problems/ everything was blurry, hot pink, with tracers; started getting black spots in vision; hard to see in the dark; Idiopathic Intracranial Hypertension or IIH meaning she had increased fluid on her brain; Idiopathic Intracranial Hypertension or IIH meaning she had increased fluid on her brain; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 at 15:00 as dose 2, single (Lot number: FC3183) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Supraventricular tachycardia (SVT)" (unspecified if ongoing); "blood clots" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: covid prior vaccination: yes; "known allergies to Ct dye" (unspecified if ongoing). Concomitant medications included: LORAZEPAM; ZOLOFT. Past drug history included: Dilaudid, reaction: "known allergy: Dilaudid"; Chantix, reaction: "known allergy: Chantix". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: FA7484, location of injection: Left arm, vaccine administration time: 03:00 AM), administration date: 18Aug2021, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: IDIOPATHIC INTRACRANIAL HYPERTENSION (hospitalization, disability, medically significant), BRAIN OEDEMA (hospitalization, disability, medically significant) all with onset 09Sep2021, outcome "not recovered" and all described as "Idiopathic Intracranial Hypertension or IIH meaning she had increased fluid on her brain"; NIGHT BLINDNESS (hospitalization, disability) with onset 09Sep2021, outcome "not recovered", described as "hard to see in the dark"; VISION BLURRED (hospitalization, disability), DYSCHROMATOPSIA (hospitalization, disability) all with onset 09Sep2021, outcome "not recovered" and all described as "vision problems/ everything was blurry, hot pink, with tracers"; VITREOUS FLOATERS (hospitalization, disability) with onset 09Sep2021, outcome "not recovered", described as "vision problems/ everything was blurry, hot pink, with tracers; started getting black spots in vision"; BLINDNESS (hospitalization, disability, medically significant), outcome "not recovered", described as "vision loss"; DEAFNESS (hospitalization, disability, medically significant), outcome "not recovered", described as "hearing loss"; HYPOVITAMINOSIS (hospitalization, disability), outcome "not recovered", described as "vitamin deficiencies"; AMNESIA (hospitalization, disability), outcome "not recovered", described as "memory loss"; MIGRAINE (hospitalization, disability), outcome "not recovered", described as "migraines daily"; PHOTOPHOBIA (hospitalization, disability), outcome "not recovered", described as "light sensitivity"; TINNITUS (hospitalization, disability), outcome "not recovered"; QUALITY OF LIFE DECREASED (hospitalization, disability), outcome "not recovered", described as "overall poor quality of life now". The patient was hospitalized for idiopathic intracranial hypertension, brain oedema, blindness, deafness, vision blurred, dyschromatopsia, vitreous floaters, night blindness, hypovitaminosis, amnesia, migraine, photophobia, tinnitus, quality of life decreased (hospitalization duration: 1 day). The events "idiopathic intracranial hypertension or IIH meaning she had increased fluid on her brain", "vision loss", "hearing loss", "vision problems/ everything was blurry, hot pink, with tracers; started getting black spots in vision", "hard to see in the dark", "vitamin deficiencies", "memory loss", "migraines daily", "light sensitivity", "tinnitus" and "overall poor quality of life now" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (unspecified date) Unknown results; Magnetic resonance imaging (MRI): (unspecified date) Unknown results; SARS-CoV-2 test: (01Aug2022) Negative, notes: Nasal Swab post vaccination. Therapeutic measures were taken as a result of idiopathic intracranial hypertension, brain oedema, blindness, deafness, vision blurred, dyschromatopsia, vitreous floaters, night blindness, hypovitaminosis, amnesia, migraine, photophobia, and tinnitus, which included spinal taps, MRIs, and diuretics. Clinical course: The patient had no other vaccine in four weeks. The vaccination facility was the hospital. The patient woke up around midnight, 9 hours after receiving the 2nd dose and had vision problems. Everything was blurry, hot pink, with tracers, and hard to see in the dark. She went to the emergency room (ER) and they said adverse reaction to Pfizer covid vaccine and should go away in 48-72 hours. They never went away. She started getting black spots in vision. After seeing multiple levels of eye care professionals, she had an MRI and spinal tap. The Neuro ophthalmologist diagnosed her with Idiopathic Intracranial Hypertension or IIH, meaning she had increased fluid on her brain. The symptoms continued to get worse as time went on. She currently has vision loss, hearing loss, vitamin deficiencies, memory loss, migraines daily, 9 new medications, light sensitivity, tinnitus, and a number of other issues. She had overall poor quality of life currently. Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the reported events were related to the vaccination with BNT162B2. 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.