Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Gait inability, Headache, Lumbar puncture, Malaise
Clinical narrative: unable to walk/ has to use a walker to walk; she literally could not walk a straight line. She had to hold on to the wall; Behind her eye, it is so gross. It feels like somebody has her optic nerve and are trying to blow it up like a balloon. That is how much pressure there is; pain has stayed between a 5 and a 7/ Clarified that this has occurred in both eyes, the right and left; sick; felt bad; vision became very distorted/ she cannot see; vision became very distorted/ she cannot see; headache; fever; body aches; chills; developed a cough; ocular migraines; has a huge blister on the inside of her mouth, all along the roof of her mouth; She can't eat, she can't drink; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 27Sep2021 17:20 (Batch/Lot Number: FF2589) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included high blood pressure, COVID-19 from Nov2020 to an unknown date , and  ruptured her blood vessels in the back of her right eye. When she had Covid back in Nov2020, she had coughed so hard that she ruptured her blood vessels in the back of her right eye. There were no concomitant medications. Patient has no additional vaccine(s) administered on same date of the Pfizer Suspect. Patient has no prior vaccinations (within 4 weeks). No Family Medical History relevant to AE(s). The patient experienced vision became very distorted/ she cannot see on 28Sep2021 with outcome of not recovered, unable to walk/ has to use a walker to walk on 30Sep2021 with outcome of not recovered; she literally could not walk a straight line, she had to hold on to the wall on 30Sep2021 with outcome of not recovered; headache on 28Sep2021 with outcome of unknown, fever on 28Sep2021 with outcome of unknown, body aches on 28Sep2021 with outcome of unknown, chills on 28Sep2021 with outcome of unknown, developed a cough in 2021 with outcome of not recovered, ocular migraines in 2021 with outcome of unknown; behind her eye, it is so gross, it feels like somebody has her optic nerve and are trying to blow it up like a balloon, that is how much pressure there is on 29Sep2021 with outcome of unknown; pain has stayed between a 5 and a 7/ clarified that this has occurred in both eyes, the right and left on 29Sep2021 with outcome of unknown; sick on 28Sep2021 with outcome of unknown, and felt bad on 28Sep2021 with outcome of unknown. These events were considered serious due to hospitalization and medically significant. The patient also experienced huge blister on the inside of her mouth, all along the roof of her mouth (non-serious) on 12Oct2021 with outcome of unknown, and she can't eat, she can't drink (non-serious) on 12Oct2021 with outcome of unknown. The event "unable to walk/she literally could not walk a straight line/ She had to hold on to the wall and furniture, the counters and everything, just to make it from one end of the house to another/ has to use a walker to walk, and is unable to drive a car" required visit to Emergency Room and Physician Office. The clinical course of events was reported as follows: Patient reported that she has had some very serious symptoms and a severe reaction to the vaccine, and she was hospitalized for 10 days. She is still unable to drive a car and her eyesight is still distorted. She now has to use a walker in order to walk around. She was trying to find out, she needs to know what to do next. She did not get second dose, and is not going to. She states she was in the hospital for 10 days and she saw her primary care doctor yesterday and an ophthalmologist as well. They really don't have answers to give her. She also reported that at the beginning, she had a headache, fever, body aches, and chills, and reports coughing as well. She was diagnosed with ocular migraines. She stated that from a healthcare perspective, she just needed her experience documented in case others had a similar experience. She said, tearfully, that she is unable to work. She added that she was a very active 49 years old person, and that it is very ironic that she got the shot, then the next day, this happened, and she cannot work. She is asking if there are any programs out there that could help her. She further reported that she got the shot Monday afternoon on 27Sep2021. On Tuesday on 28Sep2021, she woke up and felt bad, like she assumed. As a nurse, she expected when getting an immunization, lots of times you will feel bad. She had a headache, fever, body aches and chills. She took Tylenol, which kept things at bay. That Tuesday (28Sep2021), when she woke up, the days are a little hazy, she just felt really bad and her vision became very distorted/ she cannot see. She has distorted vision, and has lost so much peripheral vision on the right side. Her depth perception, like trying to go down a step, she has to hold on to her husband to determine how far to step down. Headache, fever, body aches, chills: They lasted pretty much just all day, that Tuesday 28Sep2021, then she went to bed. The next day, Wednesday, 29Sep2021, she woke up and everything else went bad. She did forget one symptom that he she has right now and states that it will sound gross. Behind her eye, it is so gross. It feels like somebody has her optic nerve and are trying to blow it up like a balloon. That is how much pressure there is. The pain has stayed between a 5 and a 7. Clarified that this has occurred in both eyes, the right and left and this started that Wednesday, on 29Sep2021. Headache, fever, body aches, chills: Seriousness: Because she is a nurse, this didn't alarm her. She thought she was going to be ok but then when she woke up that Wednesday morning, 29Sep2021, her version became distorted as soon as she got up out of bed. She could not make it down the hallway. Seriousness of distorted vision, unable to walk: Medically significant. It just depends on the outcome. She also developed a cough. When she coughs, it builds pressure, which will jump up to an 8 or 9. The pressure is usually pretty constant at 5 to 8. She had an ophthalmologist, so she made an appointment. He diagnosed her with an ocular migraine and gave her 2 migraine pills. One was to take right away and the other to take when she got home. She went home and went to bed. She was told by her doctor that if she woke up the next morning and she was still having symptoms, to go to the emergency room. When she woke up the next morning (30Sep2021), she literally could not walk a straight line. She had to hold on to the wall and furniture, the counters and everything, just to make it from one end of the house to another. She went to urgent care instead of the Emergency room because, who wants to spend all day sitting in the ER? They falsely diagnosed her with influenza A and they discharged her. She knew that it was more that the just the flu. She called her husband, and he took her to another hospital in a bigger city, where she was for 10 days. They thought she had a stroke but, the MRI and CT scan showed that there was no stroke. Clarified that Thursday, on 30Sep2021 was when she woke up feeling worse, went to the hospital and was hospitalized for 10 days. She states that she got admitted 30Sep2021 and just got out this past Sunday. Clarified that by this past Sunday, she was referring to Sunday, 10Oct2021, stating that sounds about right. She still can't walk without the use of a walker. She woke up yesterday with new symptoms. She has a huge blister on the inside of her mouth, all along the roof of her mouth on 12Oct2021. She can't eat, she can't drink. Treatment: They had her on cough syrup and had her on pain medications, including Tessalon pearls and they did a round of antibiotics. They did multiple rounds of antibiotics at a very high dose and they gave her steroids. That it is about it. States that the cough medicine they gave her was Hycadan, she believes and provided this spelling as she believes it is spelled. They gave that to her in the hospital. The pain medication they gave her was Hydrocodone 5mg and they were giving her 2 tablets. The Tessalon pearls, she has no idea what strength or dose that was. The steroid was Methyl prednisone. Suspect Product: Pfizer Covid vaccine. Indication: To be honest, she is a nurse and her and her husband had strongly agreed with each other that they were not going to take it. They had 3 friends back to back, who died of Covid and they kind of panicked and jumped on the vaccination band wagon. That day, they went and had the vaccine. Tests: They kept saying she had the million dollar work up. They did a CT scan, with and without contrast, an MRI, with and without contrast. They did a lumbar puncture, X-rays and tons of lab work while she was in the hospital. Causality of Headache, fever, body aches, chills, vision became very distorted, can't walk without use of a walker, distorted vision, ocular migraines: She just finds it very ironic. She is not trying to be a smart aleck but, she find sit very ironic that she, who is a very healthy 49 year old who works out and goes to work, got the vaccine and came home, cooked a full meal and ate dinner. Then, the next morning, Tuesday, 28Sep2021, within 12 hours of the vaccine, she was sick. She just finds that very ironic. She stated that she wakes up every morning with a new symptom. She was a healthy 49 years old and relays that she now has to use a walker and she cannot see. She audibly upset during the call. She states that she spent 10 days in the hospital and was discharged last Sunday only because there was an influx of COVID 19 patients and the doctors felt that she would be safer at home than within the hospital. She relayed that her PCP, "threw his hands up and said he didn't know what else to do". She would like to know if there is a specific doctor or hospital who she should see that will be able to help her with the side effects she is experiencing from the vaccine?; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events Metamorphopsia, Visual impairment, Gait inability, Gait disturbance,headache,pyrexia,pain,chills,cough, Ophthalmic migraine,ocular discomfort,eye pain,malaise,feeling abnormal and  the suspect drug "BNT162B2" cannot be completely 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.