Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chronic lymphocytic leukaemia, Gait disturbance, Inappropriate schedule of product administration, Off label use
Clinical narrative: almost paralyzed me from my knees to my neck, especially in my left shoulder; right shoulder is still sore; 2nd dose: ended up with weird chills and she was in bed all day; Caller shared that she had a walker, but after the second shot she now can't use the cane; Second dose on 02Apr2021; Second dose on 02Apr2021; now she has CLL; her blood calcium was high; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 79-year-old female patient received bnt162b2 (COMIRNATY), administration date 02Apr2021 (Lot number: ER8737) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lymphedema" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "diabetes" (ongoing); "Sinus problem" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Kidney failure", start date: 2008 (unspecified if ongoing); "Had the covis virus", start date: 11Dec2020 (unspecified if ongoing), notes: The patient was also hospitalized with the COVID19 virus last Dec2020. The patient mentioned she had plasma treatment, 10 days of steroids, 5 days of an antivirus. The patient's primary doctor, gave cortisone shot every 3 months but was changes to 4 months.; "uses a walker" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: EL1284), administration date: 04Jan2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "had trouble with her muscles and her shoulder", "had trouble with her muscles and her shoulder", "Had a cough". The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "almost paralyzed me from my knees to my neck, especially in my left shoulder"; CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset 2021, outcome "unknown", described as "now she has CLL"; OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 02Apr2021, outcome "unknown" and all described as "Second dose on 02Apr2021"; ARTHRALGIA (non-serious), outcome "not recovered", described as "right shoulder is still sore"; CHILLS (non-serious), outcome "unknown", described as "2nd dose: ended up with weird chills and she was in bed all day"; BLOOD CALCIUM INCREASED (non-serious) with onset 2021, outcome "unknown", described as "her blood calcium was high"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Caller shared that she had a walker, but after the second shot she now can't use the cane". The patient underwent the following laboratory tests and procedures: biopsy bone marrow: (unspecified date) unknown results; blood calcium: (Sep2020) 9.6; (2021) high, unknown level; body temperature: (11Dec2020) 103, notes: In hospital for 10 days. Therapeutic measures were taken as a result of paralysis, arthralgia. Clinical course: the patient reported to have had issues with the right shoulder, neck muscles, and knees. The patient was also diagnosed with CLL (type of leukemia; Chronic lymphocytic leukemia) in Oct/Nov2021. The patient shared that she couldn't get her doctor for 8 months, the last time she saw her was the 1st week of September. The patient confirmed she did not do any blood test after the first dose, and that most of the side effects were after the second shot. The vaccine almost paralyzed her from her knees to her neck, especially in her left shoulder. The patient can't raise it. She added that the right shoulder was still sore; When she got those shots she couldn't lift them". The patient said she was "debilitated". She had physical therapy and went back to normal, but when the patient changed therapist the condition worsened because of the arm movements. The patient added that for her "that vaccine didn't work"; "I will not get the booster". The patient said she only got the second shot because her sister insisted. The patient shared that she had a walker, but after the second shot the patient now can't use the cane. The patient had her 1st dose on 01Jan2021 and she had her 2nd dose on 02Apr2021. Since then her knees got hurt and what has bothered her the most is her shoulder. The patient wants to know if Pfizer has a research or information on the adverse reaction that she has. Transfer agent clarified the product to be the Pfizer COVID 19 vaccine. The patient says that she had the COVID virus in Dec2020. She was in the hospital with a 103 temperature for 10 days. She had plasma treatments, for 5 days she had anti-virus medications and for 10 days she had steroids. During that time she had no hurting or anything like that. Then she went to rehab and she was out of there on 07Jan2021. They gave her the first vaccine on 04Jan2021. When she got home in about a week or so she had trouble with her muscles and her shoulder, her knees didn't bother her at that time. She had cortisone shots in her shoulder which took the pain away but she was still having trouble with her right shoulder and her neck muscle. She does have degenerative bone disease that got into her muscle and her joints. With the 1st dose she just mainly had the shoulder issue. She had therapy and went and got the 2nd shot because she felt better and she was able to use her cane. She got her 2nd dose and ended up with weird chills and she was in bed all day. With the first dose she had a cough, but with the 2nd she ended up with the weird chills and she was in bed all day. She took Tylenol and she felt better. It was like the vaccine almost paralyzed her. She was trying to turn over in bed, raise her arms and move her legs normally but she had to kind of move them in baby steps. She has had to use a walker ever since then. She feels like some days she gets better and some days she feels like she gets worse again. It is like she takes one step forward and has to take 2 to 3 steps back. She is a lot better now. She did have some cortisone shots in her knee after the 2nd time and for her shoulders but now her doctor says that she can't get those but every 4 months now because she is 79 years old. They usually give them every 3 months but her doctor has switched her to every 4 months now instead. She is better now and her left arm is a lot better. She can raise it pretty good. Her right arm is still sore but she can raise it better than than she could. Her worse side is her right arm. It was even bothering her neck and stuff but she is getting better but no one can tell her anything about this. Also it took her about 8 months previously to get in with a primary care doctor and she was having her blood calcium levels checked through blood work. She also saw a cancer doctor that had to take a bone marrow test because her blood calcium was high and they didn't know why. She has CLL and had to see the cancer doctor because of that. She had mentioned to the doctor that her blood wasn't showing that before she had COVID or before she had the COVID vaccines. In Sep2020 her blood calcium was 9.6 and they haven't even told her what her reading was sine she had the most recent blood test. She also never thought to ask them what it was. She hasn't told anyone in her apartment complex about that but she did mention this all to the doctor's nurse about her having CLL after the COVID virus and the COVID vaccines. The patient did mention this to a couple of her sisters who had the shots and the boosters and they had no troubles. The patient thinks that she shouldn't have had that 2nd shot but she always learns things that are going on after she has already done it. She got the 2nd shot because she did feel better but now after her 2nd one she has been like this since 02Apr2021. Like she said she is improving but she is trying to get some information. And now she has CLL and has to be monitored for that every 3 months. She mentioned about the diagnosis after having the COVID vaccine and her doctor said that he wouldn't be telling anyone that because it might scare someone but she says, well what about her? She is all messed up now. Those shots messed her up and no one is giving her any answers. She has shrunk so she is about (withheld) and she is overweight because she has lymphedema that she got from having surgeries, like a partial hysterectomy back in 1974. She didn't know that they take your lymph glands and that causes lymph problems with that. That is another thing because that is where the virus got into, it was in her lymph and in her blood marrow. With lymphedema it doesn't get rid of poison like it should. So she has lymphedema, sleep apnea, diabetes but that it diet controlled and she is on no medicine for it, she has sinus problems and adverse reactions from the vaccine. That is what she basically has. So also does have hypertension but she takes medicine for that high blood pressure. But, her weight, she is about (withheld) or so which is too much she knows and she is trying to deal with it. She has so much drama in her life which is causing her to be an eater. Primary Healthcare Professional Info: She would prefer to not. She just wants to talk to Pfizer about it. Her doctor is not telling her anything, she thinks that she has a pretty good doctor but she is not too happy with that cancer doctor making the comment that she might scare someone if she told them that she now has CLL afterwards. But why did her blood calcium start getting high after she had the COVID problems? She need to call that doctor and find out. She had a wellness check with them previously. She also can't take Advil, Aleve or buprofen. She took some because of a strain on her neck when she was lifting something before she had COVID. She had to take therapy because of it. With the Ibuprofen she didn't take many, because she knew she shouldn't, and it stressed her kidneys. She went to see the cancer doctor and she took three Tylenol arthritis which are 650 a piece, she had 1950 mg that was put in her system just so she could get to the doctor because she was hurting and she had to go back at a later time because it had messed with her kidneys. When she went back another time and got a blood test she had drank water and stuff and her kidneys were good again. She can't mess with that stuff anymore. The patient clarifies and confirms that she had her 1st dose of the COVID vaccine on 04Jan2021, not 01Jan2021 as provided by transfer agent. She went into the hospital on 11Dec2020 and they took her temperature and it was 103 so she was there for 10 days. She went to rehab until 07Jan2021. They gave her the first dose there and they didn't know what they were doing. She signed a paper to get it but she didn't know that she shouldn't have it for 90 days after having the COVID virus and that she shouldn't have it after having the plasma treatments. They didn't know what they were doing. She confirms that the issues with her muscles and shoulders began in Jan2021. Inquired for when the cough began and she said that she had the cough when she had COVID and when she got back home she was still having it. She had a therapist that come to her apartment to try and help her manage everything. They checked her breathing and put the thing on her finger because her breath was still short. It took some time to get her breath back to normal after having COVID. She was taking therapy during the first 90 days and it really helped her get back to normal and that's when she took the 2nd shot. She wasn't going to get the 2nd shot but her younger sister said that she couldn't come around them if she didn't have the 2nd shot and since she felt normal at that time she had it. It has been havoc with her experience. It has been debilitating. She uses a walker and has to lean on it because it takes pressure off of her knees which helps. She is getting better like she said but it is taking so long. She won't take a booster because it will do the same thing again. Inquired if patient's 1st dose side effects went away prior to her receiving the 2nd dose and she says for the most part the cough was gone. She might of had an occasional cough when she was in rehab. She went to rehab 10 days after she was in the hospital and that was about 21Dec2020 or 22Dec2020 until 07Jan2021. The thing is she did get over the 1st dose side effects. She thinks that all those treatments that she had in the hospital might have helped the symptoms after she had the 2nd shot. She thinks she still had some of those treatments in her system but she was still having the trouble with her muscles for at least a week when she got home. One therapist had hung her hangers in her closet and she couldn't get them so the therapist had to move them and something else for her. When she first got home she was standing in the shower but after that she wasn't able to stand. Now she has to use a shower chair all the time because her body core from her shoulder and neck area down to her knee area is not good. She thinks that if her shoulders were to get better then she could be a lot better and pretty much normal. She even had a spot in her left hip that took a long time to heal and her therapist had her on a bike but she could only be on that once. She thinks that she had pulled something in her left hip after the 2nd shot. That is pretty much healed now but it took months to get better She knows that her days are numbered but the thing is she wanted answers. She had contacted VAERS and she can't get them to send her the paper copy that she wanted of that report. She wanted a copy for herself and she can't get them to respond. What good are they if the adverse event reporting place are not doing what she wants them to do? All she wanted was a paper copy of her reporting form and it has been 3 to 4 months now and she doesn't want to call them anymore. To her people are nothing but lairs and cowards. At her doctor's office for her cortisone shots she was told by the lady up front that she can't get it for 4 months because of something with her insurance. She is not getting the booster. She confirms that her blood calcium level was 9.6 in Sep2020 but they never told her what it was since going there and getting her blood test done again. Next time she goes she is going to ask them what the readings are. She looked on the internet and saw that blood calcium readings should be 8. something to 10. something. Hers must be higher than that. She thinks that level was from when she had a wellness check because of the strain in her neck. It seems like she had a more recent blood test, but they never said anything about her calcium being too high. When the Ibuprofen had stressed her kidneys she had to go back in 10 days and like she said she took the Tylenol arthritis, 650 mg, but she is not messing with that anymore either. She took 3 to get to the doctor because she was hurting and then they made her come back with instructions to drink more water because they didn't know why her kidneys were reading whatever they were reading. When she went back they were okay. She had kidney failure in 2008 because she was taking over the counter diet pills. Her kidney doctor said that Advil, Aleve and Ibuprofen are the worst things to take for kidneys and so like she said she can't mess with them, she doesn't want to have to go on dialysis She confirms Sep2020 is when she had the normal blood calcium levels checked and she had COVID on 11Dec2020. Inquired for when she was diagnosed with CLL and she says that she can't remember, it had to be in Oct2021 or Nov2021.  No follow-up attempts are possible. No further information is expected.