Adverse Event Reporting

VAERS ID 1514284
Gender Male
Age
StateCode FR
Pharmaceutical Company PFIZER\BIONTECH
Lot Number EX8680
Number of vaccinations 1
Vaccinated 2015-01-02
Onset 2021-06-17
Condition Hospitalized Permanent Disability
Symptoms
  • Visual impairment
  • Ophthalmological examination
  • Optic neuritis
  • Dyschromatopsia

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Test Name: examined by an ophthalmologist; Result Unstructured Data: Test Result:could not see at the top of the eye chart; Comments: The vision in the right eye was without remark

Write-up

optic neuritis; severely impaired vision in the left eye with a reduction of about 80% and alternating black and white field across the field of vision/could not see at the top of the eye chart; severely impaired vision in the left eye with a reduction of about 80% and alternating black and white field across the field of vision; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-059324.
A 49-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 16Jun2021 (batch/lot number EX8680 and expiry date unknown) as dose 1, single for covid-19 immunization and teriflunomide (AUBAGIO, tablet), oral from 02Jan2015 to 28Jun2021 (batch/lot number ONR9E and expiry date unknown) to 28Jun2021, at 14 mg, once a day for MS (multiple sclerosis).
The patient's medical history and concomitant medications were not reported.
On 17Jun2021, the patient experienced optic neuritis, severely impaired vision in the left eye with a reduction of about 80% and alternating black and white field across the field of vision.
The reporter informed that the patient adverse reaction optic neuritis left eye.
The reaction occurred the day after the first vaccination dose and 6 years after the introduction of Aubagio.
The day after the Covid vaccination, onset of severely impaired vision in the left eye with a reduction of about 80% and alternating black and white field across the field of vision.
The man was examined by an ophthalmologist at hospital (unspecified) and could not see at the top of the eye chart.
The vision in the right eye was without remark.
The case was assessed serious as hospital care (hospitalization), permanent physical impairment.
The action taken in response to the events for teriflunomide was permanently withdrawn on 28Jun2021.
The outcome of the events was recovering.
No follow-up attempts are possible.
No further information is expected.