Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Leukaemia, Mental disorder, Off label use, Platelet count
Clinical narrative: Leukaemia; Type 2 diabetes mellitus; Off label use; Acute myeloid leukemia; Dyspnoea; Mental disorder; Platelet count decreased; Haemoglobin decreased; Epistaxis; Haemorrhage; White blood cell count decreased; Pneumonia; Shortness of breath; Diabetes steroid-induced; This is a non-interventional study report from an unspecified marketing program received from a contactable consumer, information received by Pfizer from agency. (Mfr. Control No.: 21K-163-3931733-00). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular on 16May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 72-year-old) for COVID-19 immunization; venetoclax (VENCLEXTA), oral from Jun2020 (Batch/Lot Number: 1134458) to Jun2020, at 200 mg, daily, oral from Jun2020 (Batch/Lot Number: 1134458) to Mar2021, at 2 DF, daily (Take 2 tablet(s) by mouth every day (2 in 1 D)), oral from Mar2021 (Batch/Lot Number: 1134458) and ongoing, at UNK, 1x/day, oral from Jun2020 (Batch/Lot number was not reported) to Dec2020, at 200 mg, 1x/day, oral from Dec2020 (Batch/Lot number was not reported) to Jul2021, at 100 mg, 1x/day for acute myeloid leukaemia, vitamin b12 deficiency, aortic aneurysm. Medical history included type 2 diabetes mellitus, leukaemia, acute myeloid leukaemia, white blood cell count decreased, antihistamine allergy, penicillin allergy manifested by hives, unspecified abdominal pain, calculus of kidney, calculus in bladder, malignant neoplasm of prostate, unspecified urinary incontinence, male erectile dysfunction, unspecified, parkinson's disease, ileus, unspecified, familial dysautonomia, anxiety disorder, unspecified, unspecified abnormalities of gait and mobility, allergic to dye, unspecified osteoarthritis, unspecified site, essential primary hypertension, diverticulosis of intestine, part unspecified, without perforation, vitamin d deficiency, unspecified, major depressive disorder, single episode, unspecified, mastodynia, hypertrophy of breast, adverse effect of unspecified drugs, medicaments and biologics, hydroureter, dorsalgia, unspecified, acute cystitis without hematuria, calculus of ureter, thrombocytopenia, unspecified, abdominal aortic aneurysm, without rupture, deficiency of other specified b group vitamins, diabetes insipidus, alcohol user, prostate cancer, three hernia operations, intravenous contrast dye allergy manifested by breakout in hives, antiviral, antibiotic, pneumonia, unspecified urinary incontinence, penicillin allergy manifested by hives, unspecified abnormalities of mobility from an unknown date and tobacco user from an unknown date to 1987 , radical prostatectomy from 2011 to an unknown date , appendicectomy from 2013 to an unknown date. Concomitant medication(s) included azacitidine (VIDAZA) taken for acute myeloid leukaemia; aciclovir sodium (ACYCLOVIR ABBOTT VIAL) taken for antiviral treatment; levofloxacin (LEVAQUIN) taken for antibiotic therapy; metoprolol (METOPROLOL) taken for hypertension; posaconazole (POSACONAZOLE) taken for prophylaxis; allopurinol (ALLOPURINOL) taken for acute myeloid leukaemia; bicalutamide (BICALUTAMIDE) taken for prostate cancer, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for contrast media allergy, start and stop date were not reported. The patient previously took reglan [metoclopramide] and experienced sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced drug hypersensitivity, sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced urticaria. The past drug included antihistamine 12 hour tablet, penicillins, dye and Sulfa (Sulfonamide Antibiotics). Patient mentioned he started smoking when he was 14 years old and stopped on mid 30s, 40 years ago. Patient started drinking alcohol when he was 19 years old. Patient had three hernia operations for the past 15 years. The patient experienced pneumonia, platelet count decreased, haemoglobin decreased, epistaxis, haemorrhage, white blood cell count decreased, shortness of breath (hospitalization, medically significant) on 18May2021, type 2 diabetes mellitus, leukaemia (hospitalization, medically significant) on an unspecified date with outcome of unknown , acute myeloid leukemia, dyspnoea (hospitalization, medically significant) on 02Aug2021, mental disorder (hospitalization, medically significant) on 01Jun2021, diabetes steroid-induced (hospitalization, medically significant) on May2021, (dyspnoea) (hospitalization, medically significant) on 18May2021, off label use (hospitalization, medically significant) on an unspecified date. The patient was hospitalized for pneumonia (pneumonia) from May2021 to May2021. It was reported that On unknown dates, the patient experienced type 2 diabetes, leukaemia was getting worse, venclexta intentionally used for unlabeled indication/off label use and low white blood cell count. in May2021, the patient experienced steroid induced diabetes. on 18May2021, the patient experienced hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, pneumonia and low white blood cells. On 20May2021, the low haemoglobin and bleeding in the nose resolved. On 01Jun2021, the patient experienced mind scattered. In Jul2021, the bleeding in the arms resolved. On 02Aug2021, the patient experienced shortness of breath and worsened acute myeloid leukaemia. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was in the hospital for a couple of weeks in May2021 with pneumonia. The pneumonia mixed with leukaemia was a bad thing. The physician ordered him off of the medication for the duration of his hospital stay. His mind was scattered on 01Jun2021. He stated that developed type 2 diabetes and was supposed to resume chemo with VENCLEXTA and VIDAZA, missed dose. Two days after he received the Covid 19 vaccine he went to the emergency room. He was given two bags of platelets on 29Jul2021. The alternative etiology for the event of bleeding in the nose was reported as low haemoglobin and low white blood cells. The alternative etiology for the event of bleeding in the arms was reported as too much drugs. The alternative etiology for the event of steroid induced diabetes was reported as steroids. Primary reporter did not have the lot number information because his bottle was not the original bottle and he had the pharmacy bottle. In last May2021, Patient stated that he went to emergency room and had to hospitalized for two days. On 02Aug2021, Patient had hospitalized again due to the shortness of breath, worsened acute myeloid leukaemia and low white blood cell count. Patient stated that he was still in the hospital. Patient had a platelet transfusion yesterday due to the low white blood cell count and worsened acute myeloid leukaemia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 16May2021 patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with DAPSONE, PREDNISONE and INSULIN. On 16Jun2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of "type 2 diabetes" was added. On 15Jul2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of leukaemia was getting worse was added. On 30Jul2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events of hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells and steroid induced diabetes were added. On 10Aug2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology , suspect drug information and narrative description. The events of "shortness of breath, worsened acute myeloid leukaemia and low white blood cell count were added. Causality for Venclexta(Venetoclax): The reporter's causality for the event(s) of type 2 diabetes, venclexta intentionally used for unlabeled indication/off label use and mind scattered was not provided. the reporter's causality for the event(s) of leukemia was getting worse, hard time breathing, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, pneumonia, low white blood cells and steroid induced diabetes with Venclexta (Venetoclax) was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of type 2 diabetes, leukemia was getting worse, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells, venclexta intentionally used for unlabeled indication/off label use, mind scattered and steroid induced diabetes are related to Venclexta(Venetoclax). Agency's opinion is that there is a reasonable possibility that the events of hard time breathing and pneumonia are related to Venclexta (Venetoclax). The patient underwent lab tests and procedures which included haemoglobin: low on 18May2021, platelet count: low on 18May2021, ultrasound scan: pneumonia on 18May2021, ultrasound scan: pneumonia mostly cleared up on Jul2021, white blood cell count: low on 18May2021. Therapeutic measures were taken as a result of events includes two bags of platelets on 29Jul2021 and Prednisone, Insulin and Dapsone. Outcome of the events Pneumonia, dyspnoea, steroid diabetes was reported as recovering, for events acute myeloid leukemia, platelet count decreased, white blood cell count decreased it was not recovered, the events haemoglobin decreased, epistaxis, haemorrhage were recovered and unknown for events type 2 diabetes mellitus, leukaemia, mental disorder, dyspnoea and off label use.   Information about lot/batch number has been requested.; Sender's Comments: Events Pneumonia, Type 2 diabetes mellitus, Acute myeloid leukaemia, Leukaemia, Dyspnoea, Platelet count decreased, Haemoglobin decreased, Epistaxis, Haemorrhage, White blood cell count decreased, Mental disorder, Shortness of breath, Off label use most likely represent intercurrent medical conditions ( Type 2 diabetes mellitus , Leukaemia )and unrelated to bnt162b2 (COMIRNATY). Also consider effect of co-suspect drug VENETOCLAX