Reporte zur Charge PEL9261

Symptomtext

kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2?F fever; whole body was aching; tired; right kidney started aching and then the left kidney; leucocytes in her urine; high creatinine; bladder symptoms; oil bubbles in my pee/bubbles in her pee; I don't at all feel well; I have got lots of fluid in my body around my middle; put on about 5 or 6 pounds; cystitis; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. PEL9261, via an unspecified route of administration on 05Feb2021 as single dose for prevention of COVID 19 virus. No relevant medical history and no concomitant medications. The patient previously took the first dose BNT162B2 for COVID-19 immunisation (lot no. batch/lot number: EL1284). The patient received the first dose of the BNT162B2 on 15Jan2021. She had a reaction to the vaccine, had a mild reaction with first one she felt like if her heart warmed up and a burning sensation in her left side of the neck and face. She received the injection on her left side. She was kept for half an hour and then she had a mild headache and slept. She also had fever, pain at the injection site and felt very tired. She received the second dose of the vaccine 5 weeks ago. Several days after second dose on Saturday mornings, started having 100.2?F fever for two days and her whole body was aching. When the fever disappeared, she was very tired that week. Her right kidney started aching and then the left kidney, there were also bubbles in her pee and it went worse (no blood in the pee). A few weeks ago, she went to the urgent care, because a week before there were leucocytes in her urine and she took antibiotic. On Monday, she saw the urologist and the urologist sent her a CT scan and a blood test. The blood test results were abnormal so she didn't have a CT scan done because it could be dangerous. Her creatinine was high and her GFR was 41 (stage 3), she didn't know her kidney disease stage until they have the results (Monday). She was very healthy, didn't take drugs and there's no history of kidney disease in her family, also she exercised every day. She would like to know if something similar has been reported with the Pfizer-BioNtech Covid-19 vaccine because she's trying to understand these symptoms that came from nowhere. She knew the Covid-19 could cause kidney problems. She would like to know if there's any live virus in the Pfizer-BioNtech Covid-19 vaccine. She was normally completely fit and healthy. She did not have any abnormality whatsoever and no big medical history. She had the 2nd Pfizer job about 4-5 weeks ago and in the last 3 or 4 weeks at least, she has been having aching kidney, kind of oily bubbles in her urine and she went to see a doctor, a specialist to send her for some test. Today, she discovered that she got a high creatinine and low GFR so that meant have got at the moment, the picture was stage 3B Kidney disease. She had no family history of that. She never had any problems before. She just wondered whether there was any other case report like vaccine should be toxic to her kidneys. This was so out of the loose. Just so uncharacteristic. She stated that probably more than that, she thinks it started because she did not realize at first, it just made her feel tired, her kidney was aching because she was working too hard. It has developed over, it was hard to say. She had the second shot and she had fever for two days. She was so tired anyways. So, she was not exactly sure whether it began exactly when she had it but she certainly did not have it before or whether it came on a few days after or a week after, she was not sure but she knew that it has got worse and now, she was in a situation where she had a CT scan today (19Mar2021). So, she went to the doctor probably on Monday or Tuesday to find out exactly what was going on but she had absolutely no history of anything like this. She had no family history. She was completely healthy. She normally exercised, aerobic exercise most days. She was a healthcare professional (nutritionist). This had come as a complete shock to her today. She was phoning because she wanted to know if there were any other case reports. She knew it was very early and there was not much research on the vaccine but she did not know whether anybody else had reported having kidney problem. She knew you can get kidney problem with the actual disease, with the virus rather but she did not know if the vaccine could cause that. She knew it had something to do with the vaccine and obviously, it may be temporary and she can deal with it. She just needed tab a little bit insight of what to do next. She was not on her normal weight because she has put on about 5 or 6 pounds in the last few weeks. So, she thinks she had got so much fluid. She was normally 5 foot 5 (inches) and her weight was normally about 130 pounds. Actually, it was less than that so it was 127 or 128 pounds but at the moment she was 134. She had got lots of fluid in her body around her middle. When she had the second shot, she had the fever for two days on the Saturday and Sunday and got really tired on Monday and Tuesday and she went there and felt a little bit better but she cannot remember when her kidney started aching. She did not know if it was immediately or whether it was the next week. It started gradually and it had got worse in the last couple of weeks. So, the ache had got so much worse and the amount of bubbles in her pee and urinary symptoms had got worse in the last, at least probably 2 to 3 weeks or so. She had nothing at all before the second vaccination. She would say that it was shortly after she carried on feeling tired and then her kidney started aching and then she developed urinary symptoms. So, that was within a week to 2 weeks of having the shot. She definitely noticed that she had the symptoms and it may have been sooner. She was not entirely sure. It may have been the same week. She honestly cannot remember because it began gradually and she started to feel like she was getting cystitis and she did not think anything over it and then it got progressively, her kidney started hurting and she got really tired and then she just started having oily bubbles in my pee. When probed for the LOT# of vaccine, the first one looked like as EL1284, and the second one, it looked like PEL9261. It could be 4916. She had got the card but she did not know exactly. It was terrible writing. She was not sure it was hard to read. The first one was in her left shoulder and the second one was in her right shoulder. She felt it was related. It has taken incident from when she had the vaccine. Well, she was obviously not a 100 percent sure that was why she was phoning to ask if there is any other similar case report. When probed for the treatment, she stated no, not yet. She only found out today that what happened was she went to see a neurologist this week and on Monday and they organized her to have a CT scan today and some blood work and when she got to the CT scan center today and they looked at the blood work and they said that her levels were too abnormal to have the CT scan with the contrast dye. It would be dangerous. So, that was when she found out it was an abnormal result. So, it just happened today. So, she had not even seen the results of the scan yet and had not seen the doctor but she just knew that her blood was abnormal and her kidney was not functioning properly and trying to find out whether it was related to the vaccine because she needed to find out how to manage it going forward. She was hoping if it was due to the vaccine she can, it has been toxic stroke to her kidney and then she can workout how to deal with it hopefully reverse the situation but she had no Idea but she was just trying to get the feeling for what this could be. She did not have the results of the CT scan yet. She only got the results of the blood which said her kidney, when she went to have the scan her doctor asked her to have the scan and then to have a second scan to what they call a contrast dye and the technician said that when he looked at her blood results he said she cannot give her the contrast dye it was too dangerous. She needed to phone the doctor and so he phoned the doctor and the doctor said just do the scan without the contrast dye and they told her what the blood results were. So, she looked online and she can see that it was Stage 3B Kidney disease and she was in the stage of shock and she was feeling before she went to have this test that this was related to the vaccine because it has come since she has had the vaccine, so close to her having it so now she was more convinced and she just wanted to see anybody else has had this. Obviously, the doctor would not know about this because this was so new and so she needed to workout on how to deal with what has happened to her. Her creatinine was 2 and GFR was 41. With second one she had the fever for few days and she felt very tired, and then she developed some bladder symptoms, and she thought maybe she just had something like cystitis, and then she was very tired, her kidney started aching and particularly on the right hand side but on the left as well, it's got worse and worse to point that she got oil bubbles in her pee and she went to see neurologist on Monday, she had the blood test and today she got scan, a CT scan and she meant to have a consult after the scan with the scan but when they saw the blood result, which she has not seen, they said that was so abnormal they could not get her the contrast dye, so they said because of the result, she suddenly got out of nowhere and stage 3B kidney disease, and she had not gotten the result of the scan yet but she has sent in on stay, but she didn't at all feel well, haven't felt well since she had the vaccine she personally felt it had something to do with the vaccine because she did not have any family history of kidney disease or anything related to that and she never had an issue, never even had kidney infection so, she phoned up today to off Pfizer whether there have been any other case reports, because she had to go back and see her Urologist now and he won't know because it's obviously such early days with the vaccine and there not any proper Clinical Trials to, she would think to reflect this. She was concerned about the side effects and she just wanted to know because now, she knew had to deal with it, and she was, obviously that came as big shock to her that she just wanted to, if there have been any, she knew that the Covid virus can cause kidney disease, but I didn't know whether the vaccine has been showing to do that in any other individual. Results of tests and procedures for investigation of the patient on 15Mar2021: blood test, result: creatinine 2 and GFR 41. The outcome of fever and tired was recovering, while outcome of other events was unknown. Information on the lot/batch number has been requested.