Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Retinogram, Vision blurred, Visual field tests
Clinical narrative: blurriness on the right eye with consistent optic neuritis; read up on transverse myelitis that may be related to her condition; blurriness on the right eye with consistent optic neuritis; This is a spontaneous report from a contactable physician. This physician (patient) reported for self that the 31-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on Deltoid, Left on 20Dec2020 13:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Reported she has a flu vaccine in Sep2020, and had no reaction to the flu vaccine. She clarified she has never had a reaction to a vaccination before. The patient received the vaccine last 20Dec2020 and has reported to have blurriness on the right eye with consistent optic neuritis since 24Dec2020. She has already consulted with an ophthalmologist who said her case was interesting and referred her to Pfizer. She is scheduled to have her second dose on 10Jan2021 and is asking if she should still take it. She also mentioned that she read up on transverse myelitis that may be related to her condition and is asking for any information we may have on this. Doctor reporting she is having a possible adverse event to the COVID-19 Vaccine. The patient clarified she received the COVID-19 Vaccine on Sunday, 20Dec2020 at approximately 1:00PM. Reported the COVID-19 Vaccine was administered at her employer. Doctor reported she is experiencing blurry vision in her right eye only, consistent with optic neuritis in Dec2020 (Medically significant). She said her right eye blurry vision gets worse after working out or showering. She said she has read some medical information that states some kind of autoimmune reaction, like transfer myelitis, may occur after receiving the COVID-19 Vaccine. The patient asked if she should get the second COVID-19 Vaccine, clarifying she is scheduled to receive her second dose on 10Jan2021. Clarified she started experiencing the right eye blurry vision on either 24Dec2020 or 25Dec2020. Treatment: Reported she saw an ophthalmologist, and the ophthalmologist said he didn't see anything concerning or not normal. She said the ophthalmologist referred her to see a neurologist, and to get a MRI of her head. She clarified her MRI appointment is on 19Jan2021. She clarified her ophthalmologist called her back 2 hours after she left her appointment. She said the ophthalmologist told her he found what she was experiencing to be interesting, as to when she received the COVID-19 Vaccine, and the start of her right eye blurry vision, and that he wanted her to get further evaluation. She said the ophthalmologist performed visual field testing, and took a fancy picture of her retina. No further details provided. Vaccination Facility Type was hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) required a visit to Emergency Room but AE(s) required a visit to Physician Office. Prior Vaccinations (within 4 weeks) was none. Patient's Medical History(including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. Relevant Tests included Visual field test, and picture of her retina. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events optic neuritis, vision blurred and myelitis transverse cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.