Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram, Demyelination, Diplopia, Dizziness
Clinical narrative: abnormal cerebral white matter signal abnormalities; multiple speleological demyelinating process; double vision in his right eye/double vision in his left eye; his vision floats; Dizziness; unusual changes in the right eye; This is a spontaneous report from a contactable consumer (patient) and from a contactable physician. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0191) intramuscularly on 30Jun2021 at 10:59 (also reported as 11:10, at the age of 65-years-old) as a single dose in the deltoid left for COVID-19 immunization. Medical history included ongoing hypertension (blood pressure is under control with losartan potassium) and osteoarthritis, both from 2014. Illness at vaccination was reported as none. Family medical history relevant to the adverse events was reported as none known. Concomitant medications included hydrochlorothiazide/losartan potassium (LOSARTAN POTASSIUM AND HCTZ; strength: 25/100) orally taken for hypertension from an unspecified date ("for a long time, way beyond the two-week time period leading up to the events") and ongoing at 1 DF (1 DF = 100/25) and meloxicam orally taken for an unspecified indication from an unspecified date and ongoing at 65 mg. The patient previously received flu shots on unspecified dates for immunization and had no adverse effects (flu shots do not affect him any- he had no adverse effects with the flu shots). The patient did not receive any prior vaccinations (within 4 weeks) of the COVID-19 vaccine. The patient did not receive any other vaccines that were administered on the same date as the COVID-19 vaccine. The patient did not have any adverse events that followed prior vaccinations since he was a kid. On 03Jul2021 (reported as 3 days after the vaccine) the patient experienced double vision in his right eye/double vision in his left eye, his vision floats, dizziness, unusual changes in the right eye and on an unspecified date the patient experienced multiple speleological demyelinating process and abnormal cerebral white matter signal abnormalities. Seriousness criteria for the event abnormal cerebral white matter signal abnormalities was reported as persistent / significant disability / incapacity. The patient reported that he received his first dose of the COVID-19 vaccine on 30Jun20221 and on the fourth day (also reported as 3 days later), he woke up in the morning and had double vision in his right eye and he stated that his vision floated. He had this for a week, and it went away for about 3 or 4 days and it came back in his left eye. The patient still had it. He went to an ophthalmologist, optician, and his personal doctor. His doctor was now running all kinds of tests to see what the problem was. The patient also had dizziness which he believed was from the double vision, but it could be from the shot. Upon follow-up received on 23Aug2021 from the physician, it was reported that the patient had the COVID-19 vaccination and 3 days later developed unusual changes in the right eye. The patient saw an eye doctor and was told he was ok and was referred to the physician. The patient was still with symptoms and the MRI showed abnormal cerebral white matter signal abnormalities. He had been referred to a neurologist for further workup. Evaluation decreases to read out multiple speleological demyelinating process (as reported). It was reported that the work-up specialist exclusion was ongoing. The adverse events required a visit to the physician office. It was unknown whether treatment was received for the events double vision in his right eye/double vision in his left eye, his vision floats and dizziness. The patient underwent lab test and procedures that included: CAT scan on an unspecified date with unknown results and MRI on an unspecified date that revealed abnormal cerebral white matter signal abnormalities; TSH on 20Jul2021 which was 1.06 (normal), CBC on 20Jul2021 which was normal, AIC on 20Jul2021 which was 5.8% (normal) and CMP on 20Jul2021 which was ok. The clinical outcomes of the events double vision in his right eye/double vision in his left eye, his vision floats and dizziness were not recovered/not resolved while the clinical outcomes of the events unusual changes in the right eye, multiple speleological demyelinating process and abnormal cerebral white matter signal abnormalities were unknown.  Follow-up attempts are completed. No further information is expected.