Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Angle closure glaucoma, Condition aggravated, Erythema, Intraocular pressure test, Pruritus
Clinical narrative: full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously; full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously; Hands and wrist got red and itchy; Hands and wrist got red and itchy/ Back of right leg was itchy; Back of right leg was itchy and had a couple of bumps; This is a spontaneous from a contactable nurse (patient). A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 68-years-old, intramuscular in left arm on 12Jan2021 at 08:40 at single dose for COVID-19 immunization and paracetamol (ARTHRITIS PAIN RELIEVER ACETAMINOPHEN, lot number: 9ER0473, expiration date: Mar2021), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history included narrow-angle glaucoma; arthritis probably on 2000 in which she had both knees replaced in 2016, she has had different issues with arthritis since then; and hypertension. The patient has no known allergies. Concomitant medications included lisinopril for hypertension and naproxen sodium (ALEVE). No additional vaccines were administered on the same date as BNT162B2. The patient received a flu shot on Dec2020. She experienced worst arm pain from the newer pneumonia shot. She thought it was the Prevnar. The older one she did not have. On 12Jan2021 at 18:00, about 8 hours after vaccination (as reported) which was administered in a hospital, the patient experienced a full-blown narrow angle glaucoma. She was told that she had narrow angle glaucoma before. She saw a doctor prior to this though, back in Nov2020, for a routine visit and everything was normal. She had not had any attacks and was not on any medication for it previously. That night of the vaccine, she had rainbow colored halos around both eyes. She called her ophthalmologist and spoke to the doctor who was on call that night. He wanted to see her the next morning. Her pressures were a little high and they started her on drops. She then saw her regular ophthalmologist that afternoon. She had been seeing him every 4 months for the narrow angle glaucoma previously and had been fine since her last visit in Nov2020. It seemed like a coincidence. She reported since she knew it would take a while for all of the data to come back and she has not gotten the second one. The specialist said it could be triggered from the vaccine. Name of the drops she put on was Alphagan P. She no longer has it. She believed it was 1%, one drop in each eye, twice daily. She was taking a sample of that and currently, was taking generic Brimonidine 0.2% ophthalmic solution, 5mL, one drop in each eye twice daily. The patient was also on pilocarpine hcl. She went to an institute for a specialist. Nobody saw if there was anything in the literature. She reported to VAERS. She was calling to see if Pfizer has heard if there were any other cases.  Someone did call her back and she tried to search the data base. She was not very tech savvy. She has not had any problems. Nothing like that before hand. No problem since then. She has no known allergies. The only other thing was weird was that on 12Jan2021 at 16:00, 6-8 hours later (as reported), both her hands and wrist got red and itchy, to the point she went outside and stuck them in a snow bank. She did not have an anaphylactic reaction. She then said maybe some transient itching in other places and mentioned some bumps on the back of her right leg that were itchy. She did not know if it was worthy of reporting. She used to be 5 feet. She shrunk and it occurred before the vaccine. It was age related. The next dose, she may get the Johnson and Johnson, something that does not have the MRNA in it. She did not have to go to the hospital, but saw 3 different doctors for appointments for glaucoma. She needed significant intervention based on that. It was the beginning of using eye drops, which she never had. When she went to bed, she still had the halo's and when she woke up, they were gone. So, they went away on their own some time during the night. Her pressures were still elevated in her eye though compared to normal. When she went in at 08:00, the visual check was not as good as it normally was.  She did not know, but guesses she was 20/40 and normally was about 20/25.  It just wasn't as good as it was prior. Now it was back to 20/25. She mentioned that she takes some over the counter stuff and lisinopril for blood pressure. She took ALEVE afterwards but she takes Aleve every day. About 4 pm, she also took TYLENOL. She could not take antihistamines or decongestant because they could trigger. She was looking at the vaccine to see if there was an ingredient that could have caused it and she did not find anything.  She wanted to make sure the TYLENOL did not cause it. She was just looking at other variables. That was the one thing that was not normal to her. She was just trying to figure it out. She almost never takes TYLENOL and may have gotten rid of it.  She then clarified that it was generic,  ARTHRITIS PAIN RELIEVER ACETAMINOPHEN. She only took one. Once you think you are itchy, then everything is itchy. She used a mirror to see the back of her leg and was able to see her hands. She did not see any other bumps or redness though. She did not do anything about itchiness or redness. It got her attention, but she did not talk to any doctor about it. It went away.  When it happened, she was concerned.  She did not know how to characterize it. Somewhere between not serious and medically significant. She did not seek treatment for it. She was unable to confirm seriousness of bumps on her leg as well but mentioned that it went away. She was unable to determine if it was going to get worse. She could not take BENADRYL because of her eyes. She could not even treat it and take an antihistamine. The action taken in response to the events for paracetamol was unknown. The outcome of the events was recovered on an unspecified date in 2021. The events "angle full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously", "Hands and wrist got red and itchy", and "Hands and wrist got red and itchy/ Back of right leg was itchy" were assessed as serious medically significant.; Sender's Comments: Based on the close temporal relationship, the association between the events "angle closure glaucoma aggravation, erythema, and pruritus" with BNT162b2 can not be fully excluded.  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.