Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine, Blood folate
Clinical narrative: Bladder infections; Platelets just above the high end of normal at 452,000/Plt count increased one time/ Platelet count 452 (high); Lymphocytes decreased/Lymphocytes are decreased intermittently/Lymphocytes 0.6 (low); Immature granulocyte high/Immature granulocyte count has been elevated continuously/ Immature granulocyte 0.07/0.10/0.12/0.09 (high); Glucose level high/ Glucose level 102/193/145/137 (high); Glom filtration rate low/GFR has always been low/ Glom filtration rate 80/56/68/59/64/79/68 (low); Sodium level low/Blood sodium is low intermittently/ sodium level 135 (low); Mean cell volume increased; MCHC 31.8 (low); RDW 15.4 High; Monocyte 1.1 (high); Hemoglobin A1c 6.4 high; Anion gap 12 (high); Folate level (more than 24) high; RBC (NM) (M/UL) 3.71/ RBC value 3.81/ 3.82/ 3.75/Red blood cell count decreased; Hemoglobin decreased/ Hemoglobin 11.6/ 11.7; Hematocrit decreased/ hematocrit 35.8/ 35.4; I had a hard time breathing for a week after; Mild bilateral hip pain; Fever; Frequent urinary tract infections/UTI; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; ruxolitinib phosphate (JAKAFI), first regimen since 04Sep2014 (Lot number: 8020520, Expiration Date: 30Sep2021) at 15 mg 2x/day (15 mg, 2x/day (q12h)), oral, second regimen since 19Apr2017 (Lot number: 1848559, Expiration Date: 31Jul2023) at 15 mg 1x/day (15 mg, 1x/day (qd)), oral, third regimen since 19Apr2017 (Lot number: 1848560, Expiration Date: 31Jul2023) at 15 mg 1x/day (15 mg, 1x/day (qd)), oral, fourth regimen since Sep2012 (Batch/Lot number: unknown) at 15 mg 1x/day (15 mg, 1x/day ( qd)), oral, fifth regimen since 20Apr2017 (Lot number: 1848570, Expiration Date: 31Oct2023) at 15 mg 1x/day (15 mg, 1x/day ( qd)), oral, sixth regimen since Apr2017 (Lot number: 1962214, Expiration Date: 29Feb2024) at 15 mg 1x/day (15 mg, 1x/day ( qd)), oral and seventh regimen (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day (15 mg, 1x/day ( 15 mg tablets qd on an unknown date)) for myelofibrosis, polycythaemia vera, myeloproliferative neoplasm. The patient's relevant medical history included: "Surgery" (unspecified if ongoing); "Bladder catheterization" (ongoing), notes: self-catheterizing for 13 years; "Essential thrombocytosis", start date: 14Mar2011 (unspecified if ongoing), notes: Current Condition; "JAK-2 mutation", start date: 14Mar2011 (unspecified if ongoing), notes: Current Condition; "Iron deficiency anemia", start date: 16Jul2014 (ongoing); "Constipation" (ongoing), notes: had ongoing lifetime constipation; "Hypothyroidism" (unspecified if ongoing); "Dyslipidemia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Palpitations" (ongoing); "Osteoporosis" (unspecified if ongoing); "Cataracts" (ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Transient ischaemic attack" (unspecified if ongoing); "Bladder suspension", start date: 16Sep2009 (unspecified if ongoing); "Cholecystectomy", start date: 1996 (unspecified if ongoing); "Appendectomy", start date: 1968 (unspecified if ongoing); "Tubal ligation", start date: 1979 (unspecified if ongoing); "Varicose veins stripping", start date: 2008 (unspecified if ongoing); "Allergy to antibiotic" (ongoing); "Drug allergy" (ongoing); "Bladder injury" (ongoing); "Essential thrombocythemia" (ongoing); "Myeloproliferative disorder" (ongoing); "The patient stated the she gets UTI often" (ongoing); "bladder infections" (ongoing), notes: As had been self-catheterizing for 13 years. Concomitant medication(s) included: OMEGA 3 FISH OILS; ASPIRIN 81; LEVOTHYROXINE; XANAX; PROTONIX [OMEPRAZOLE]; COLACE; CALCIUM; CARVEDILOL; MIRALAX; PROBIOTIC BLEND; SIMVASTATIN. Past drug history included: Agrylin for Product used for unknown indication; Hydrea for Product used for unknown indication; Busulfan for Product used for unknown indication; Iron 324mg for Iron deficiency, notes: 324mg, oral. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URINARY TRACT INFECTION BACTERIAL (medically significant) with onset Aug2022, outcome "unknown", described as "Frequent urinary tract infections/UTI"; CYSTITIS BACTERIAL (medically significant), outcome "unknown", described as "Bladder infections"; PLATELET COUNT INCREASED (non-serious), outcome "unknown", described as "Platelets just above the high end of normal at 452,000/Plt count increased one time/ Platelet count 452 (high)"; LYMPHOCYTE COUNT DECREASED (non-serious), outcome "unknown", described as "Lymphocytes decreased/Lymphocytes are decreased intermittently/Lymphocytes 0.6 (low)"; IMMATURE GRANULOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "Immature granulocyte high/Immature granulocyte count has been elevated continuously/ Immature granulocyte 0.07/0.10/0.12/0.09 (high)"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose level high/ Glucose level 102/193/145/137 (high)"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "Glom filtration rate low/GFR has always been low/ Glom filtration rate 80/56/68/59/64/79/68 (low)"; BLOOD SODIUM DECREASED (non-serious), outcome "unknown", described as "Sodium level low/Blood sodium is low intermittently/ sodium level 135 (low)"; MEAN CELL VOLUME INCREASED (non-serious), outcome "unknown"; MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED (non-serious), outcome "unknown", described as "MCHC 31.8 (low)"; RED CELL DISTRIBUTION WIDTH INCREASED (non-serious), outcome "unknown", described as "RDW 15.4 High"; MONOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "Monocyte 1.1 (high)"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious), outcome "unknown", described as "Hemoglobin A1c 6.4 high"; ANION GAP INCREASED (non-serious), outcome "unknown", described as "Anion gap 12 (high)"; BLOOD FOLATE INCREASED (non-serious), outcome "unknown", described as "Folate level (more than 24) high"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "RBC (NM) (M/UL) 3.71/ RBC value 3.81/ 3.82/ 3.75/Red blood cell count decreased"; HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "Hemoglobin decreased/ Hemoglobin 11.6/ 11.7"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "Hematocrit decreased/ hematocrit 35.8/ 35.4"; DYSPNOEA (non-serious), outcome "unknown", described as "I had a hard time breathing for a week after"; ARTHRALGIA (non-serious), outcome "unknown", described as "Mild bilateral hip pain"; PYREXIA (non-serious), outcome "recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (24Jan2021) N/A, notes: 14 N/A; (27Apr2021) N/A, notes: 16 N/A; (22Oct2021) N/A, notes: 15 N/A; (20Dec2021) N/A, notes: 19 N/A; Albumin globulin ratio: (27Apr2021) N/A, notes: 1.7 N/A; (22Oct2021) N/A, notes: 1.3 N/A; (20Dec2021) N/A, notes: 1.4 N/A; (24Jan2022) N/A, notes: 1.4 N/A; Anion gap: (27Apr2021) N/A, notes: 7.0 N/A; (22Oct2021) N/A, notes: 8.0 N/A; (20Dec2021) N/A, notes: 12.0 N/A H; (24Jan2022) N/A, notes: 9.0 N/A; Aspartate aminotransferase: (27Apr2021) N/A, notes: 21 N/A; (22Oct2021) N/A, notes: 22 N/A; (20Dec2021) N/A, notes: 25 N/A; (24Jan2022) N/A, notes: 20 N/A; Basophil count: (27Apr2021) N/A, notes: 0.1 N/A; (27Apr2021) 1.1 %, notes: Not applicable; (22Oct2021) 0.6 %, notes: Not applicable; (20Dec2021) N/A, notes: 0.1 N/A; (20Dec2021) 0.8 %, notes: Not applicable; (24Jan2022) N/A, notes: 0.1 N/A; (24Jan2022) 0.8 %, notes: Not applicable; Biopsy bone marrow: (14Mar2011) Myelofibrosis and Essential thrombocytosis; Blood albumin: (27Apr2021) N/A, notes: 3.8 N/A; (22Oct2021) N/A, notes: 3.9 N/A; (20Dec2021) N/A, notes: 4.0 N/A; (24Jan2022) N/A, notes: 3.9 N/A; Blood alkaline phosphatase: (27Apr2021) N/A, notes: 45 N/A; (22Oct2021) N/A, notes: 69 N/A; (20Dec2021) N/A, notes: 51 N/A; (24Jan2022) N/A, notes: 44 N/A; Blood bilirubin: (27Apr2021) N/A, notes: 0.6 N/A; (22Oct2021) N/A, notes: 0.4 N/A; (20Dec2021) N/A, notes: 0.7 N/A; (24Jan2022) N/A, notes: 0.5 N/A; Blood calcium: (27Apr2021) N/A, notes: 9.2 N/A; (22Oct2021) N/A, notes: 9.2 N/A; (20Dec2021) N/A, notes: 9.6 N/A; (24Jan2022) N/A, notes: 9.1 N/A; Blood chloride: (27Apr2021) N/A, notes: 102 N/A; (22Oct2021) N/A, notes: 100 N/A; (20Dec2021) N/A, notes: 100 N/A; (24Jan2022) N/A, notes: 102 N/A; Blood creatinine: (27Apr2021) N/A, notes: 0.91 N/A; (22Oct2021) N/A, notes: 0.80 N/A; (20Dec2021) N/A, notes: 0.95 N/A; (24Jan2022) N/A, notes: 0.70 N/A; Blood folate: (22Oct2021) N/A, notes: 24 N/A H; (24Jan2022) N/A, notes: 20 N/A; Blood glucose: (27Apr2021) 137 mg/dl, notes: H; (22Oct2021) 145 mg/dl, notes: increased; (22Oct2021) 145 mg/dl, notes: H; (20Dec2021) 193 mg/dl, notes: H; (24Jan2022) 102 mg/dl, notes: H; Blood glucose: (unspecified date) 137; Blood iron: (27Apr2021) N/A, notes: 83 N/A; (20Dec2021) N/A, notes: 82 N/A; (24Jan2022) N/A, notes: 69 N/A; Blood lactate dehydrogenase: (24Jan2022) N/A, notes: 160 N/A; Blood potassium: (27Apr2021) N/A, notes: 4.4 N/A; (22Oct2021) N/A, notes: 4.4 N/A; (20Dec2021) N/A, notes: 4.2 N/A; (24Jan2022) N/A, notes: 4.3 N/A; Blood sodium: (27Apr2021) 137 mmol/L, notes: Not applicable; (22Oct2021) 135 mmol/L, notes: L; (22Oct2021) 135 mmol/L, notes: decreased; (20Dec2021) 136 mmol/L, notes: Not applicable; (24Jan2022) 136 mmol/L, notes: Not applicable; Blood urea: (27Apr2021) N/A, notes: 20 N/A; (22Oct2021) N/A, notes: 16 N/A; (20Dec2021) N/A, notes: 14 N/A; (24Jan2022) N/A, notes: 15 N/A; Carbon dioxide: (27Apr2021) N/A, notes: 28 N/A; (22Oct2021) N/A, notes: 27 N/A; (20Dec2021) N/A, notes: 24 N/A; (24Jan2022) N/A, notes: 25 N/A; Eosinophil count: (27Apr2021) 1.5 %, notes: Not applicable; (27Apr2021) N/A, notes: 0.1 N/A; (22Oct2021) 2.0 %, notes: Not applicable; (22Oct2021) N/A, notes: 0.2 N/A; (20Dec2021) N/A, notes: 0.2 N/A; (20Dec2021) 2.0 %, notes: Not applicable; (24Jan2022) N/A, notes: 0.1 N/A; (24Jan2022) 1.3 %, notes: Not applicable; Full blood count: (27Apr2021) N/A, notes: 341 N/A; (22Oct2021) N/A, notes: 341 N/A; (20Dec2021) N/A, notes: 274 N/A; (24Jan2022) N/A, notes: 274 N/A; Glomerular filtration rate: (unspecified date) 93@L, 64@L, 79@L, 68@L; Glomerular filtration rate: (27Apr2021) 59 ml/min, notes: 59 milligram per minute; (22Oct2021) 68 ml/min, notes: 68 milligram per minute; (22Oct2021) 68 ml/min, notes: 68 milligram per minute, decreased; (20Dec2021) 56 ml/min, notes: 56 milligram per minute; (24Jan2022) 80 ml/min, notes: 80 milligram per minute; Glycosylated haemoglobin: (08Nov2021) N/A, notes: 6.4 N/A, H; Haematocrit: (27Apr2021) 36.8 %, notes: Not applicable; (22Oct2021) 35.4 %, notes: L; (22Oct2021) 35.4 %, notes: decreased; (20Dec2021) 35.8 %, notes: L; (24Jan2022) 37.8 %, notes: Not applicable; Haemoglobin: (27Apr2021) 11.7 g/dl, notes: L; (22Oct2021) 11.6 g/dl, notes: decreased; (22Oct2021) 11.6 g/dl, notes: L; (20Dec2021) 12.0 g/dl, notes: Not applicable; (24Jan2022) 12.1 g/dl, notes: Not applicable; Haemoglobin: (unspecified date) 11.6; (16Jul2014) 10.3; Immature granulocyte count: (27Apr2021) 1.4 %, notes: Not applicable; (27Apr2021) N/A, notes: 0.09 N/A H; (22Oct2021) 1.4 %, notes: increased; (22Oct2021) N/A, notes: 0.12 N/A H; (22Oct2021) 1.4 %, notes: Not applicable; (08Nov2021) 1.4 %, notes: Not applicable; (20Dec2021) N/A, notes: 0.10 N/A, H; (24Jan2022) N/A, notes: 0.07 N/A, H; (24Jan2022) 0.8 %, notes: Not applicable; Laboratory counts: (unspecified date) mild and intermittent; Lymphocyte count: (27Apr2021) 1.1 %, notes: L; (27Apr2021) N/A, notes: 1.1 N/A; (22Oct2021) 7.6 %, notes: decreased; (22Oct2021) N/A, notes: 0.6 N/A; (22Oct2021) 0.6 %, notes: L; (08Nov2021) 1.1 %, notes: Not applicable; (20Dec2021) N/A, notes: 1.1 N/A; (24Jan2022) 0.6 %, notes: L; (24Jan2022) N/A, notes: 0.6 N/A; Mean cell haemoglobin: (27Apr2021) N/A, notes: 30.7 N/A; (27Apr2021) N/A, notes: concentration 31.8 N/A, L; (22Oct2021) N/A, notes: 31.3 N/A; (22Oct2021) N/A, notes: concentration 32.8 N/A; (22Oct2021) N/A, notes: concentration 32.8 N/A; (08Nov2021) N/A, notes: 32.0 N/A; (20Dec2021) N/A, notes: concentration 33.5 N/A; (24Jan2022) N/A, notes: 31.7 N/A; (24Jan2022) N/A, notes: concentration 32.0 N/A; Mean cell volume: (27Apr2021) N/A, notes: 96.6 N/A; (22Oct2021) N/A, notes: 95.4 N/A; (08Nov2021) N/A, notes: 95.5 N/A; (24Jan2022) N/A, notes: 99.0 N/A, H; Mean platelet volume: (27Apr2021) N/A, notes: 9.4 N/A; (22Oct2021) N/A, notes: 9.8 N/A; (20Dec2021) N/A, notes: 9.5 N/A; (24Jan2022) N/A, notes: 9.8 N/A; Monocyte count: (27Apr2021) 10.1 %, notes: Not applicable; (27Apr2021) N/A, notes: 0.7 N/A; (22Oct2021) N/A, notes: 0.9 N/A; (22Oct2021) 10.5 %, notes: Not applicable; (20Dec2021) N/A, notes: 0.8 N/A; (20Dec2021) 10.5 %, notes: Not applicable; (24Jan2022) 12.7 %, notes: Not applicable; (24Jan2022) N/A, notes: 1.1 N/A, H; Neutrophil count: (27Apr2021) 69.0 %, notes: Neutrophil count; (27Apr2021) N/A, notes: 4.5 N/A; (22Oct2021) 77.9 %, notes: Not applicable; (22Oct2021) N/A, notes: 6.7 N/A; (20Dec2021) N/A, notes: 5.2 N/A; (20Dec2021) 70.2 %, notes: Not applicable; (24Jan2022) N/A, notes: 6.9 N/A; (24Jan2022) 77.3 %, notes: Not applicable; Platelet count: (unspecified date) just above high end of normal at 452,000; (Aug2012) 848,000; (27Apr2021) 409 thousand, notes: 409 K/uL; (22Oct2021) 452 thousand, notes: 452 K/uL, H; (22Oct2021) 452 thousand, notes: 452 K/uL, increased; (20Dec2021) 391 thousand, notes: 391 K/uL; (24Jan2022) 383 thousand, notes: 383 K/uL; Protein total normal: (27Apr2021) N/A, notes: 6.1 N/A; (22Oct2021) N/A, notes: 6.9 N/A; (20Dec2021) N/A, notes: 6.8 N/A; (24Jan2022) N/A, notes: 6.6 N/A; Red blood cell count: (27Apr2021) 3.81 million per microlitre, notes: L; (22Oct2021) 3.71 million per microlitre, notes: L; (22Oct2021) 3.71 million per microlitre, notes: decreased; (20Dec2021) 3.75 million per microlitre, notes: L; (24Jan2022) 3.82 million per microlitre, notes: L; Red cell distribution width: (27Apr2021) N/A, notes: 14.3 N/A; (22Oct2021) N/A, notes: 14.6 N/A; (20Dec2021) N/A, notes: 15.4 N/A, H; (24Jan2022) N/A, notes: 14.7 N/A; Serum ferritin: (unspecified date) 25; (16Jul2014) 6; (27Apr2021) N/A, notes: 18 N/A; (22Oct2021) N/A, notes: 25 N/A; (20Dec2021) N/A, notes: 290 N/A; (24Jan2022) N/A, notes: 141 N/A; Vitamin D: (unspecified date) low; White blood cell count: (27Apr2021) N/A, notes: 6.6 N/A; (22Oct2021) N/A, notes: 8.6 N/A; (20Dec2021) N/A, notes: 7.4 N/A; (24Jan2022) N/A, notes: 9.0 N/A. The action taken for ruxolitinib phosphate was dosage not changed. Therapeutic measures were taken as a result of urinary tract infection bacterial.  Clinical course: One pill from 10/21 dispense was cracked (Product physical issue). The patient experienced frequent urinary tract infections (UTI) and was taking Bactrim (sulfamethoxazole, trimethoprim). Other family medical history reported as, Thyroid disorder NOS (Thyroid disorder) (Current Condition All 3 daughters) (ongoing). Uterine cancer (Uterine cancer) (Historical Condition Mother at age 38), Heart attack (Myocardial infarction) (Historical Condition Father), Gastric cancer (Gastric cancer) (Historical Maternal uncle). Additional case numbers for this patient includes: 2019IN001480, 2020IN004136 and 2022IN002107.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.