Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Platelet count, Platelet count abnormal, Product dose omission issue
Clinical narrative: Left chest fracture; Stress fracture in one of her feet; HGT 36.6/Hematocrit-37.2%; Osteoporosis in her spine and hips/Osteoporosis had worsened/Osteoporosis; A compressed area in spine; No longer run due to the osteoporosis in her spine being severe/used to be able to run/now she just walks/Before osteoporosis I used run; Hemoglobin A1C has increased, 6.1/A1C was 5.9/lt have been in the 5.5-5.6 range; Cold symptoms/head congestion; Rebuilding her endurance for the half marathon; Boot to wear for 3-6 weeks; Worsening tingling in her toes; Memory issue; Sometimes what was in her head was not the same thing that came out of her mouth; RBC's were a wee bit low; dropping from prior of 4.17 to 3.79/RBCs mildly Jow/RBC 3.94/Red blood cell count was 3.7/Red blood; Platelet count down to 550K\ Platelet count was 602/PJatelet count 551/Platelets were 541 (lowest it's been in years)/platelet level was 539/Platelets-587; Potassium has also been consistently high (5,4 this time); Numbness to feet bilaterally; Pre osteoporosis on both sides of my hip; I had a sore arm for less than 24 hours after each Pfizer COVID vaccine; Missed her morning dose of Jakafi/Missed 2 doses of Jakafi/Missed a dose of Jakafi on Christmas day/I missed PM dose of Jakafi; She has gained 10 pounds over last yeartgaining weigh/Gained a pound; Cholesterol levels elevated, cholesterol 215, LDL cholesterol 122/Total cholesterol increased to 200/total cholesterol 215/total; Feeling tired/worsening fatigue/Occasional fatigue/Increased fatigue/More tired/It seems to be more progressive/Tiredness/tired; Cold symptoms/head congestion and then a cough/Cough; Itching; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation; ruxolitinib phosphate (JAKAFI), via an unspecified route of administration from 24Aug2016 (Batch/Lot number was not reported) and ongoing, at 15 mg for polycythemia vera. Medical history included ongoing white blood cell count abnormal, ongoing red blood cell count abnormal, ongoing hematocrit abnormal, ongoing platelet count increased, ongoing tingling and ongoing osteoporosis. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); calcium citrate; chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN); diphenhydramine hydrochloride (BENADRYL). The patient experienced a compressed area in spine, Osteoporosis in her spine and hips/Osteoporosis had worsened/osteoporosis, No longer run due to the osteoporosis in her spine being severe/used to be able to run/now she just walks/Before osteoporosis patient used run, Haemoglobin AIC has increased, 6.1/A1C was 5.9/It have been in the 5.5-5.6 range. Stress fracture in one of her feet, Platelet count is dropping but is still high: 661000/platelets were 664, Cold symptoms/head congestion,Rebuilding her endurance for the half marathon, Boot to wear lot 3-6 weeks, Waking aid user, Worsening tingling. in her toes, Memory issue (Memory impairment sometimes whitewash in her head was not the same thing that came out of her mouth thinking abnormal), RBC's were a wee bit low; dropping from prior of 4.17 to 3.79 (on 27Jul2017)/RBCs mildly low/RBC 3.64/Red blood cell count was 3.Y/Red blood cells-3.99, Platelet count down to ss0K/ Platelet count was 60Z/Platelet count 551/Platelets were 541 (lowest it's been on 10May2020) platelet level was 539/Platelets-58Y, Potassium has also been consistently high, 5.4 this time on 27Jul2027 Numbness to feet bilaterally, Pre osteoporosis on both sides of my hip. patient had a sore arm for less than 24 hours after each Pfizer COVID vaccine, Missed 2doses of Jakafi in the past month from the forget to take the dose, Missed her morning dose of Jakafi on 14MAR2017/Missed 2 doses of Jakafi/Missed a dose of Jakafi on Christmas day/patient missed PM dose of Jakafi [Product dose omission issue], She had gained 10 pounds over last year/gaining weight/Gained a pound, Cholesterol levels elevated, cholesterol 215, LDL cholesterol 122/Total cholesterol increased to 200/total cholesterol 215/total cholesterol back down to 203/LDL increased from 115 to 122, back to 114, Feeling tired Morning fatigue/Occasional fatigue/increased fatigue/More tired/It seems to be more progressive/Tiredness/Tired, Cold symptoms/head congestion and then a cough, itching, HCT 36.6/Hematocrit 37.2%. Clinical course: On an unspecified date, reported as over the last year, the patient has gained a total of 10 pounds. Upon follow-up, the patient developed osteoporosis over the past three years from the time of the report. A bone scan was performed, reported as three years ago from the time of the report, and stated that the patient had osteoporosis in her spine and hips. Another bone scan performed, reported as a year ago from the time of the report, and stated that nothing had changed, but the patient was told that she should no longer run due to the osteoporosis in her spine being severe. The patient's haemoglobin AIC had increased. The patient's HbAl 1C had always been between 5.6 and 5.9. In SEP2018, the patient's HbA1C was 6.1. The patient's cholesterol levels were elevated. On an unspecified date: last year from the time of the report, the patient's total cholesterol was 200 and her LDL cholesterol was 115. OnSEP20.18, the patient's total cholesterol was 215 and her LDL cholesterol was 122. The patient also experienced feeling tired and gaining weight since starting Jakafi on an unknown date. Upon follow-up, starling on an unknown date, the patient had osteoporosis in her spine (previously reported). About a year and a half ago, the patient used to be able to run but had to quit and just walks now due to the osteoporosis. The patients orthopaedic surgeon did an x-ray and gave her a boot to wear for three to six weeks. The patient noticed that this time, she walked faster than in training and was not used to the shoes. On an unknown date, the patient ran a half marathon and had a stress fracture in one of her feet. Since an unknown date, the patient's platelet count was dropping, but was still high at 661,000 (no units and reference ranges were provided). On 06DEC2018, Thursday, the patient got cold symptoms 'with head congestion and had a cough when she tried to talk or lay down flat. On 11DEC2018, the day of the report, the patient was doing much better. Upon follow-up, the patient reported that she had polycythaemia Vera and she initially started Jakafi because her WBC, RBC and haematocrit were out of balance, but her platelets were 1,6 million (units and reference ranges not provided). On 07Mar2019, the patient had her blood work done. Her WBC was reported as within normal limits (value not provided) on 07Mar2019, and her platelets were 664 (units and reference ranges not provided) on 07Mar2019. As slated by the: patient, even though it was high, that was where she had stabilized at. On an unspecified date, the patient had a left chest fracture. The patient also noted that she had been rebuilding her endurance for the. half marathon since she was a runner. Upon follow-up since an unknown date, the patient had been experiencing worsening tingling in her toes. Jakafi had taken care of all the other side effects that she had experienced with polycythaemia Vera except the toe. Tingling. Also, since unknown dates, the patient had been experiencing cough, worsening fatigue (which was not keeping her from doing things), memory issue, and stated that "sometimes what was in her head was not the same thing that came out of her mouth, The patient's physician was aware. Upon follow up, the patient stated that her baseline bone density test had been normal when she was 50 years old. On an unspecified date in 2015, before starting Jakafi, the bone density test showed that she was developing osteoporosis. Since starting Jakafi, the patient osteoporosis had worsened. Since starting Jakafi, the patient's cholesterol levels had also increased. The patient stated that she had never experienced issues with elevated cholesterol before starting Jakafi. However, on an unspecified date in 2017, a year after starting JaKafi, the patient's total cholesterol increased to 200 (units and reference range not provided). On an unspecified date in 2018, her total cholesterol was 215 in Sep2018. On an unspecified date, reported as recently, the patient's total cholesterol was back down to 203. Since starling Jakafi, her cholesterol levels had increased, On an unspecified date, the patient's LDL levels increased from 115 to 122 (in Sep2018), and on an unspecified date in 2019, her LDL was back to 114 (units and reference range not provided). The patient was using diet and exercise la manage her cholesterol levels. On an unspecified date, reported as recently, the patient's bone density test showed that she had a compressed area in her spine art her osteoporosis had worsened. Stress fracture in one of her feet, Boot to wear for 3-6 weeks, Platelet count is dropping but is still high: 661000, Cold symptoms/head congestion, Gough, and Itching were added. Data fields and narrative were updated accordingly. In Dec2017, WBC, RBC, HCT, platelet count was slightly low. On 14MAR2017, the patient missed her morning dose of Jakafi. On z7zuL2017, the patient's red blood cells (RBC's) were a "wee bit low; dropping from prior value of 4.1Y to 3.79 (units and normal ranges not provided). On unspecified dates, she missed 2 doses of Jakafi (previously reported) in the past month from forgetting. The patient missed 2 doses of Jakafi (previously reported) between JAN2017 to JUL2017 (dates unknown) and the patient's last platelet count was down to SSOK. According to the patient, this was the best it had been in years. On Christmas Day. (25DEC2017) the patient missed a dose. She was traveling and turned her phone for church and forgot to take the dose. On 25Jan2018, she had gained a pound; and her weight was 112-pound (lbs.) at her medical doctor (MD) visit, On the same day, her platelet count was 602 on 25Jan2018. The patient reported results of blood work drawn on 26APR2018 - WBC (white blood cells) was 6.1 on 26Apr2018, RBC was 4.33 on 26Apr2018, HCT (haematocrit) was 41.5%, and platelet count was 656 on 26Apr2018. And counts were slightly up from the blood draw results. on an unknown date in DEC2017. The patient also experienced occasional fatigue since an unspecified date. On an unspecified date, the patient's: blood work showed: WBC 5.4, RBC 3.94, HCT 36.6%, and platelet count 551. No units and reference ranges were provided. Per the patient's physician this was the best the patient's blood work looked in years. The patient continued with Jakafi at the time of the report. On 10MAR2020, patient's platelet count was 54.1 and that was the lowest she had been in years. The patient's potassium levels had been consistently high on the higher side of normal. At the time of the report, it was at 5.4. The patient had looked into changing her diet to cut out all high potassium foods for which she had been eating a lot. On unknown date, the patient experienced an increased fatigue. The patient also mentioned that she has numbness to feet bilaterally and has osteoporosis. According to the patient, her last platelet level was 539, which for her, was the best that her platelets have been in a long time, On an unknown date, the patient had been more tired. It seemed to be progressive over the last 3-4 years. As stated by the patient, she would be doing something, she would last about 3-4 hours and then she would just get so tired. The patient usually was napping about once a day for an hour. The patient was sleeping at night and was usually: getting 7-8 hours of sleep at night. The patient did like to walk and was walking 2-4 miles a day. Before, the patient had osteoporosis, the patient used to run. The patient had quit doing her exercise classes and she tried to do that at home, but she was not very disciplined. The patient's tiredness did not stop her from doing what she needed to do. The patient's osteoporosis had worsened. On 19OCT2020, the patient started on a generic of alendronate sodium 35mg once a week on Monday. The osteoporosis was bad on her spine and then she had pre osteoporosis on both sides of her hips. On an unknown date, the patient's red blood cell count was 3.7. The patient's cho1esterol was up at 215. Since she had been on Jakafi. it had been around 210-215. The patient's high-density lipoprotein (HDL) was 77 and LDL was 118. The patient's doctor said these were a little high, but they were not concerned. The patient AIC was 5.9. Over the last 5-6 years, it had been in the 5.5-5.6 range. The patient was not a big meat eater, but she did have a sweet tooth. The patient's doctor said they would rather see her put on weight than see her to cut back on calories and break a bone. Upon follow up, on unknown dates, the patient had a sore arm for less than 24 hours. after each covid vaccine. On 20JAN2021, the patient missed PM dose of Jakafi, On 23MA2021, the patient had blood work done with results of white blood cells- 5.2 (unit and reference range were not provided) on 23Mar2021, red blood celIs- 3.99 (unit and reference range were not provided) on 23Mar2021, Haematocrit- 37.2% (reference range were not provided) and platelets 587 (unit and reference range were not provided) on 23Mar2021. The action taken in response to the events for ruxolitinib phosphate was dose not changed. The outcome of events was unknown.