Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebral haemorrhage, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Craniotomy
Clinical narrative: CRANIOTOMY; BRAIN BLEED; ACUTE ON CHRONIC SUBDURAL HEMATOMA; MIXED HYPERLIPIDEMIA; LYMPHOCYTOSIS/SEVERE LYMPHOCYTOSIS; DYSLIPIDEMIA; HYPERTENSION; DEHYDRATION; CHRONIC ANEMIA/WORSENING ANEMIA; POOR ORAL INTAKE; ELEVATED WHITE BLOOD CELL COUNT; NAUSEA; EXTREME FATIGUE; FELT WARM; HEMOGLOBIN DOWN TO 7.7; FEELING UNWELL; FELT VERY WEAK; GENERALIZED WEAKNESS/WEAKNESS PROGRESSIVELY WORSE; HAD BEEN DRY HEAVING; HYPERURICEMIA; HAD NOT BEEN EATING; This solicited report received from a consumer by a Business partner (Agency, US-ABBVIE-21K-163-3972726-00) concerned a 74 year old female of unspecified race and ethnicity. The patient's weight was 99.9 kilograms, and height was 167.6 centimeters. The patient's past medical history included: left mastectomy, familial risk factor, family history of cancer, family history of cardiovascular disorder, and family history of diabetes, and concurrent conditions included: breast cancer, clostridium difficile colitis, subdural hematoma, chemotherapy induced pancytopenia, lymphadenopathy, chemotherapy, chronic lymphocytic leukemia, and anemia secondary to bone marrow suppression from chemotherapy, and other pre-existing medical conditions included: The patient had no known allergies. The patient had family history of grandmother had hypertension. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was initiated treatment with ibrutinib (tablet, oral, batch number: UNKNOWN) 420 mg, 1 time every 1 day from 17-MAR-2021 to 06-APR-2021 for an unspecified indication. Concomitant medications included venetoclax for chronic lymphocytic leukemia, prochlorperazine maleate for nausea, paracetamol for pain, allopurinol, amlodipine, benzocaine, bisacodyl, calcium carbonate, calcium carbonate/colecalciferol, docusate sodium/senna alexandrina, hydralazine hydrochloride, hydromorphone hydrochloride, lidocaine hydrochloride, magnesium oxide, naloxone hydrochloride, naproxen sodium, oxycodone, sodium chloride, and vitamins nos.  On 11-OCT-2015, Laboratory data included: CO2 (NR: not provided) 27.0. On 2021, the patient experienced had been dry heaving, hyperuricemia. On 18-FEB-2021, Laboratory data included: Lymphocyte count (NR: not provided) 147.9. On 22-FEB-2021, Laboratory data included: CT scan neck (NR: not provided) Not reported, and Chest CT (NR: not provided) Not reported. On 25-FEB-2021, Laboratory data included: Lymph node biopsy (NR: not provided) Not reported. On 10-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Not reported, Body height (NR: not provided) 167.6 cm, Body temperature (NR: not provided) 97 F, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) Not reported, and Respiratory rate (NR: not provided) 20. On 15-MAR-2021, after vaccine the patient had extreme fatigue and felt warm. On 27-MAR-2021, Laboratory data included: Blood urea nitrogen/creatinine ratio (NR: not provided) 20.61.On 31-MAR-2021, Laboratory data included: Red cell distribution width (NR: not provided) Not reported. On 06-APR-2021, the patient admitted to hospital for acute chronic subdural hematoma, left front parietal. The patient stated that post left craniotomy (date unspecified), evacuation of subdural hematoma performed first on 08-APR-2021 and then on 14-APR-2021. The patient also stated that there was no headache, fever, chills, night sweats, cough, shortness of breath, nausea, vomiting or diarrhea and only experienced worm like thickening in craniotomy site at that time. The patient went for acute visit (Date unspecified) and felt very weak and she had been getting weaker and her hemoglobin last week was 7.8, offered packed red blood cell (PRBC) to treat. The patient had no bleeding, no night sweats or fevers and no appetite had been nauseated at that time.  Laboratory data included: Absolute lymphocyte count (NR: not provided) 343.8 H, Absolute monocyte count (NR: not provided) 3.7 H, Absolute neutrophil count (NR: not provided) 9.9 H, Alanine aminotransferase (NR: 0 - 55) 12 U/L, Albumin globulin ratio (NR: 1.1 - 2.3) 1.2, Alkaline phosphatase (NR: 40 - 150) 82 U/L, Basophil count (NR: 0.0 - 0.1) 0.1 10*3/uL, Basophils (NR: 0.0 - 1.0) 0.0 %, Bilirubin total (NR: 0.2 - 1.2) 0.8 mg/dL, Blood urea nitrogen (NR: 7.0 - 26.0) 15.0 mg/dL, Blood urea nitrogen/creatinine ratio (NR: not provided) 18.07, Chloride (NR: 98 - 107) 105 mmol/mL, Creatinine (NR: 0.55 - 1.02) 0.83 mg/dL, Eosinophil count (NR: not provided) 0.5 H, Eosinophils (NR: 0.0 - 3.0) 0.1 %, Globulin (NR: 1.3 - 3.2) 3.0 g/dL, Glomerular filtration rate (NR: not provided) 60, Glucose (NR: not provided) 119 H, Hematocrit (NR: not provided) 31.7 L, Hemoglobin (NR: not provided) 7.7 L, Lactate dehydrogenase (NR: 125 - 220) 258 U/L, Lymphocytes (NR: not provided) 94.9 H, MCHC (mean corpuscular hemoglobin concentration) (NR: not provided) 24.3 L, MCV (mean corpuscular volume (NR: not provided) 108.9 H, Mean platelet volume (NR: not provided) Not reported, 10.4 H, Monocytes (NR: not provided) 1.0 L, Neutrophils (NR: not provided) 2.8 L, Platelet count (NR: not provided) 144 L, Potassium (NR: 3.5 - 5.1) 4.9 mmol/L, Protein total (NR: 6.4 - 8.3) 6.5 g/dL, Sodium (NR: 136 - 145) 140 mmol/L, and WBC count (NR: not provided) 362.4 H. On 08-APR-2021, the patient experienced brain bleed. On 01-JUL-2021, the patient was started on second line obintuzumab/Venetoclax, and was continuing Venetoclax 300 mg daily, plan would be a total of a year on Venetoclax, but patient did not receive obintuzumab at the time of report. It was reported that, the patient continue to drink at least 6 to 8 glasses of water a day. On 17-AUG-2021, Laboratory data included: Body height (NR: not provided) 167.6 cm.  On 12-NOV-2021, Laboratory data included: Absolute lymphocyte count (NR: not provided) 0.8 L, Absolute monocyte count (NR: 0.1 - 0.7) 0.5 10*3/uL, Alanine aminotransferase (NR: not provided) 36 H, Albumin globulin ratio 1.4, Alkaline phosphatase 77 U/L, Basophils (NR: 0.0 - 0.1) 0.0 10*3/uL, Basophils 0.7 %, Bilirubin total 0.8 mg/dL, Blood pressure (NR: not provided) 137/79 mmHg, Blood urea nitrogen 16.0 mg/dL, Body temperature (NR: not provided) 98.1 F, Calcium (NR: 8.4 - 10.2) 9.8 mg/dL, 8.9 mg/dL, Creatinine 0.73 mg/dL, Eosinophil count (NR: 0.0 - 0.3) 0.0 10*3/uL, Eosinophils (NR: not provided) 0.7, Globulin 3.0 g/dL, Glomerular filtration rate (NR: not provided) 60, Glucose (NR: not provided) 140 H, Hematocrit (NR: 33.0 - 51.0) 37.4 %, Hemoglobin (NR: 12.0 - 16.0) 12.6 g/dL, Lymphocytes (NR: 24.0 - 44.0) 25.3 %, MCHC (mean corpuscular hemoglobin concentration) (NR: 33.0 - 36.0) 33.7 g/dL, MCV (mean corpuscular volume) (NR: not provided) 87.6, Mean platelet volume (NR: 6.5 - 10.0) 9.7 fL, Monocytes (NR: not provided) 16.8 H, Neutrophils (NR: 35.0 - 77.0) 54.9 %, Oxygen saturation (NR: not provided) 95 %, Platelet count (NR: 150 - 450) 175 10*3/uL, Potassium 4.1 mmol/L, Potassium (NR: not provided) 4.1, Protein total 7.1 g/dL, Pulse rate (NR: not provided) 89, RBC count (NR: 4.00 - 5.20) 4.27 10*6/uL, RBC count (NR: not provided) 2.91 L, Red cell distribution width (NR: not provided) 16.1 H, Respiratory rate (NR: not provided) 16, Sodium 140 mmol/L, WBC count (NR: not provided) 3.0 L, and Weight (NR: not provided) 99.9 kg, 98 kg.  On 04-DEC-2021, Laboratory data included: Blood pressure (NR: not provided) 138/66 mmHg, Body temperature (NR: not provided) 36.3 Degrees C, Oxygen saturation (NR: not provided) 94 %, Pulse rate (NR: not provided) 86, and Respiratory rate (NR: not provided) 18.  On 2021 date unspecified, the patient had generalized weakness and visited clinic, and was feeling unwell, poor oral intake, had not been eating, felt warm on occasion. Since the weakness has gotten progressively worse, the patient had done with follow-up labs and was noted to have worsening  chronic anemia with hemoglobin down to 7.7, patient has elevated white blood cell count at 364,000 with severe lymphocytosis.  On an unspecified date, the patient also experienced, elevated white blood cell count, mixed hyperlipidemia, lymphocytosis/severe lymphocytosis, dyslipidemia, hypertension, dehydration, chronic anemia/worsening anemia, and nausea. It was reported that, patient lymphadenopathy were improved since the beginning of chemotherapy. The patient had blood transfusion, packed red blood cells (PRBC) for anemia and also had oral chemotherapy for Chronic lymphocytic leukemia (CLL) which was on hold. It was reported that, the patient labs were elevated which was presumed due to Chronic lymphocytic leukemia (CLL). Laboratory data (dates unspecified) included: Absolute neutrophil count (NR: not provided) 1.7, Absolute neutrophil count (NR: 1.5 - 8.5) 1.7 10*3/uL, Albumin (NR: not provided) 4.1, 3.5, Antibody test (NR: not provided) Not reported, Blood grouping (NR: not provided) B, Chloride 103 mmol/L, Head CT (NR: not provided) Not reported, Hemoglobin (NR: not provided) 7.8, Rhesus antigen (NR: not provided) Positive, Uric acid (NR: not provided) 4.7, and White blood cell count (NR: not provided) 364000. It was also reported that  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ibrutinib was withdrawn on 06-APR-2021. The patient had not recovered from generalized weakness/weakness progressively worse, and chronic anemia/worsening anemia, and the outcome of brain bleed, acute on chronic subdural hematoma, craniotomy, had not been eating, poor oral intake, elevated white blood cell count, felt warm, mixed hyperlipidemia, dyslipidemia, had been dry heaving, felt very weak, hyperuricemia, feeling unwell, hemoglobin down to 7.7, lymphocytosis/severe lymphocytosis, nausea, extreme fatigue, dehydration and hypertension was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and brain bleed, acute on chronic subdural hematoma, craniotomy, had not been eating, poor oral intake, elevated white blood cell count, mixed hyperlipidemia, lymphocytosis/severe lymphocytosis, dyslipidemia, hypertension, dehydration, had been dry heaving, hyperuricemia, chronic anemia/worsening anemia, and hemoglobin down to 7.7 was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, felt very weak, generalized weakness/weakness progressively worse, extreme fatigue, felt warm and nausea was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, involving the same patient is linked to 20220134969.  Additional information was received from reporter on 10-Jan-2022. The following information was updated and incorporated into the case narrative: covid-19 vaccine ad26.cov2.s was added as suspect and re-ranked the product. Following receipt of additional information from reporter on 10-Jan-2022. It was determined that nullification and deletion was required for Manufacturer Report Number (20220134969) as it was duplicate of Manufacturer Case Number (20210702361). All relevant information regarding Manufacturer Report Number (20220134969) will be submitted under Manufacturer Case Number (20210702361).; Sender's Comments: V3- This version updates covid-19 vaccine ad26.cov2.s was added as suspect and re-ranked the product. 20210702361- covid-19 vaccine ad26.cov2.s-Brain bleed, Acute on chronic subdural hematoma, Craniotomy. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS; MEDICAL HISTORY  20210702361-Imbruvica- Craniotomy. Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE  20210702361-Imbruvica-Brain bleed. Acute on chronic subdural hematoma.. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related.