Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides, Prostatic specific antigen, Total cholesterol/HDL ratio, Vision blurred, Visual acuity reduced
Clinical narrative: Vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye; loss of his peripheral vision; the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading; his vision was getting a little worse; This is a spontaneous report from a contactable 84-year-old retired pharmacist (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on an 15Apr2021 at 12:00 (at the age of 84-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included ongoing prostate problems from an unspecified date (for probably 15 years), ongoing high blood pressure from an unspecified date (diagnosed with high blood pressure 12-15 years ago), ongoing high cholesterol from an unspecified date (he cannot remember when he was diagnosed with high cholesterol. His cholesterol has been great, since he had been taking cholesterol medications, he has had normal cholesterol. He thought his total cholesterol last time was 170 and that his triglycerides were low), blood pressure from an unspecified date and unspecified if ongoing, heartburn from an unspecified date and unspecified if ongoing and eye problems from an unspecified date and ongoing. The patient did not have a history of adverse events following prior vaccinations. Family medical history relevant to the adverse event was reported as the patient's sister had eye problems. She had to get an injection in her eye every couple of weeks or once a month or something. He did not know if his sister had macular degeneration or what. Other than wearing eye glasses, that was the only family history that he could think of that might be relevant. Concomitant mediations included morniflumate (FLOMAX; capsule) taken for prostate from an unspecified date and ongoing at 1 DF 2x/day (8-10 years ago, started with 1 capsule daily but now took 1 capsule twice daily; the patient reported that at his last report, his PSA was up to 9 and it was now down to 3.1); finasteride (PROSCAR) taken for prostate from an unspecified date and ongoing; hydrochlorothiazide/lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for an unspecified indication from an unspecified date and ongoing (for quite a long time); omeprazole (PRILOSEC) taken for heartburn from an unspecified date and ongoing, as needed (if the patient knew that he was going to have something spicy or tomato based for dinner, he knew he would get heartburn, so he would take a Prilosec in the morning. He had used Prilosec for years off and on, since he was working as a pharmacist and he retired in 2013) and atorvastatin calcium taken for cholesterol from an unspecified date and ongoing (for about a year; he was changed from Zocor because the medication did not get along with his blood pressure sometimes). The patient previously received zocor on an unspecified date for an unspecified indication and experienced did not get along with his blood pressure sometimes. The patient did not receive additional vaccines on the same date or within 4 weeks prior to the COVID-19 vaccine. The patient received the flu (INFLUENZA VACCINE), pneumonia (PNEUMOCOCCAL VACCINE) and shingles (VARICELLA ZOSTER VACCINE) vaccines all at the end of 2020 (at the age of 84-years-old) for immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EB8730) via an unspecified route of administration on an 25Mar2021 (at the age of 84-years-old) as a single dose in the left arm for COVID-19 immunisation. In Apr2021 the patient experienced vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye, loss of his peripheral vision, the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading and his vision was getting a little worse. The clinical course was reported as follows: The patient was a retired pharmacist who called to find out whether there had been any reports of vision complications after the COVID-19 vaccine. He received the second dose of the COVID-19 vaccine on 15Apr2021 and as of about 2 weeks ago, the peripheral vision in his right eye was getting cloudy and the patient was getting a dark spot in the bottom part of the vision of his right eye. He did not know if Pfizer had any types of reports on that type of side effect. He made an appointment with his eye doctor for tomorrow, 04May2021. He wanted to have any information that Pfizer might have. He knew that his eye doctor was going to ask him questions to try to determine what was causing the vision changes. He wanted to check with Pfizer before he went to the eye doctor so that he had an answer to the doctor's questions. The patient reported that his vision was getting a little worse. He was now having a little trouble with the computer. He had to refocus every time he moved his eyes. Yesterday, 02May2021, he had what could have been a problem driving. He was driving on the highway and there was a lighted sign. He could not read the sign because it was on the right side of the road. By the time he could focus on the sign, he could not read it because he was right by the sign. Something like that could be a big problem. He reported that his eyes go in and out of focus while reading. He had to re-focus when he was going to the next line of text that he was reading. He just got an eye exam and new glasses in Feb2021. His problem in Feb2021 was with focus. He was having problems more or less with reading. In the bright light, everything was fine, but that in regular kitchen or incandescent light, he would only be able to read a paragraph or so. He would then have to refocus in order to read more. It became a real problem and the new glasses that he got were not solving it. The patient stated that the last Pfizer representative he spoke with said that Pfizer did not have any vision changes listed as a side effect of the COVID-19 vaccine that the representative knew of. The Pfizer representative informed the caller that there may have been calls that have come in reporting vision changes, but vision changes were not listed as a side effect yet. The patient stated that he saw about 5 doctors. His primary care physician did not know about the vision changes as the changes had just occurred in the last 2 weeks. The patient had absolutely no reaction to either dose of the COVID-19 vaccine. He did not even have a sore arm following the COVID-19 vaccine injections. The vision changes started about 2 weeks ago and he wanted to wait to see if it was going to clear up before he made appointments with his physicians. He reported that his vision did not clear up and that he was now getting concerned, especially with driving. The adverse events required a visit to the physician office. The clinical outcomes of the events vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye, loss of his peripheral vision, the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading and his vision was getting a little worse were not recovered/not resolved. The patient reported that he did not believe (doubted that) that the COVID-19 vaccine caused his vision changes.; Sender's Comments: Based on the information available the changes in vision in this 84-year old patient is attributed to  patient's advanced age and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).