Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 test, Scleral disorder, Visual impairment
Clinical narrative: problems with my eyes/I nearly lost sight in my right eye; dilated blood vessels in eyes; eye blood vessel rupture; permanent scar in my sclera; Allergic reaction; Allergic reaction/ Alcohol, Preservatives, Potassium sorbate,sodium bicarbonate, Toothpaste; PICA; pains and dilated blood vessels in my eyes; redness in eyes; My eyes will also be itchy; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Dec2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 17:19 (Lot number: FA6780) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "miscarriage", start date: 17Oct2020, stop date: 10Nov2020; "Monthly period twice in Dec", start date: 01Dec2020, stop date: 28Dec2020, notes: 01Dec2020 to 07Dec2020 and 21Dec2020 to 28Dec2020; "Malaria" (unspecified if ongoing), notes: from age 3 to 13 years I had malaria every month; "anemia" (unspecified if ongoing); "dry eye" (unspecified if ongoing). Family history included: "Hypertension" (unspecified if ongoing); "Diabetis" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID taken for anaemia, start date: 18Oct2020 (ongoing); OMEGA 3 NATURAL taken for dry eye, start date: 28Oct2021, stop date: 24Nov2021; AREDS 2 VISUAL ADVANTAGE taken for eye pain, start date: 28Oct2021, stop date: 07Nov2021; NASONEX taken for hypersensitivity, NATURE MADE FOLIC ACID taken for anaemia, start date: 10Nov2021, stop date: 13Nov2021. Additional concomitant medication included Gagle eye Omega (3 Dry eye Assist) oral from 28Oct2021 to 24Nov2021 for dry eye.  Past drug history included: Quinine for malaria; Chloroquine for malaria. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks of vaccination. The patient did not have COVID-19 prior to vaccination. The patient dose not smoke, and only drinks alcohol on special occasions. The patient does not use pills contraceptives or nor plant c1, the patient had only been using condoms. The patient's diet consisted of fish, chicken, vegetable and cereal. The following information was reported: VISUAL IMPAIRMENT (disability), outcome "unknown", described as "problems with my eyes/I nearly lost sight in my right eye"; OCULAR VASCULAR DISORDER (disability, medically significant), outcome "unknown", described as "dilated blood vessels in eyes"; EYE HAEMORRHAGE (disability, medically significant), outcome "unknown", described as "eye blood vessel rupture"; SCLERAL DISORDER (disability, medically significant), outcome "unknown", described as "permanent scar in my sclera"; EYE PAIN (disability) with onset 15Aug2021 16:15, outcome "not recovered", described as "pains and dilated blood vessels in my eyes"; OCULAR HYPERAEMIA (non-serious) with onset 15Aug2021 16:15, outcome "not recovered", described as "redness in eyes"; EYE PRURITUS (non-serious) with onset 15Aug2021 16:15, outcome "not recovered", described as "My eyes will also be itchy"; FOOD ALLERGY (non-serious), outcome "unknown", described as "Allergic reaction"; ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "Allergic reaction/ Alcohol, Preservatives, Potassium sorbate,sodium bicarbonate, Toothpaste"; PICA (non-serious), outcome "unknown", described as "PICA". The events "problems with my eyes/i nearly lost sight in my right eye", "dilated blood vessels in eyes", "eye blood vessel rupture", "pains and dilated blood vessels in my eyes", "redness in eyes" and "my eyes will also be itchy" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: (14Oct2021) h57.11 occular pain; full blood count: (14Oct2021) h57.11 occular pain; red blood cell sedimentation rate: (14Oct2021) h57.11 occular pain; sars-cov-2 test: (14Aug2021) negative. Therapeutic measures were taken as a result of visual impairment, ocular vascular disorder, eye haemorrhage, scleral disorder, eye pain, ocular hyperaemia, eye pruritus and included Restasis eye drops 0.05 % eye drops in a dropperette, (One) drop into both eyes twice a day for a month, then continued for another 3 months. The patient reported the clinical course as follows:  On 15Aug2021 at 16:15 I started having problems with my eyes, it began with my right eye now it's in both, whenever I would brush my tooth I will feel pains in my eyes so I changed several brands of toothpaste, because of the sensitivity, redness in eyes, pains and dilated blood vessels in my eyes. I am currently using Colgate total clean I don't have much reaction with it. Then when I eat foods with preservatives like Potassium Sorbate I have pains, dilated blood vessels in my eyes, redness, If I eat fruits with too much vitamin C I also noticed Redness in my eyes, dilated blood vessels and pain I can no longer enjoy spices in my food especially those which have Coumarin (Warfin) Which are Black peppers, cloves, Cinnamon, ginger, Tumeric If by any chance I eat any food with this spices without knowing. I will have very visible dilated blood vessels all over my eyes and sometimes they end up bleeding and leave spots in my eyes. My eyes will also be itchy, painful and red. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient had eye itching, pain, redness and Dilated blood vessels which afterwards rupture and leaves wound treated wound permanent scar in my sclera. In the right eye I nearly lost my eye now its better after a month treatment but scars are permanent, in my right eye the ruptured blood vessel left with scars on my sclera the left eye I had dilator superficial blood vessels in sclera. The patient stated "Left eyes has similar symptoms I have to stay away from my triggers". The triggers were reported as the patient had become allergic to spices containing Coumarin (Warfin), Cloves, Turmeric, Cinnamon, Ginger, Too much vitamin C, Pineapples, Lemons, Preservatives, Potassium sorbate in food, Toothpaste:now using Colgate to protection reaction is mild, Himalaya salt, Honey, Alcohol (Red wine, white wine) react to sulphate, can't use sensodine paradantix/crast my eye react, react of pancake/waffle flow (I can't eat pancakes any more reaction to the sodium bicarbonate or preservative. The patient stated as monthly passes by she realized she has become more and more sensitive to lots of everything and her eye are the one more affected. The patient had been monitoring in these two weeks to see if my eye allergies with (waffin) spices has subside, but still the same. On 14Oct2021 I had right and left eyes, examine was to open back after two weeks. 27Oct2021 I opened at the doctors and was given a dose of restasis eye drop for both eyes for last for a month.   The reporter considered the Pfizer product did have a causal effect to the adverse events.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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