Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic myeloid leukaemia, Full blood count, Overdose, SARS-CoV-2 test
Clinical narrative: Chronic Myeloid Leukemia; Dose Number: 1, Date of start of drug: 21Feb2021 / Dose Number: 2, Date of start of drug: 21Feb2021; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9264) via an intramuscular route of administration in left arm on 21Feb2021 at 16:15 (age at vaccination 61-year-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6200) via an unspecified route of administration in left arm on 21Feb2021 (age at vaccination 61-year-old) as dose 2, single for Covid-19 immunization. Patients medical history included asthma and fuchs. Patient did not have any known allergies. Patients concomitant medications included Vitamin C [Ascorbic Acid], Vitamin D3 and multivitamins (ascorbic acid, biotin, calcium, choline bitartrate, chromium, copper, folic acid, inositol, iodine, iron, magnesium, manganese, molybdenum, nicotinamide, pantothenic acid, phosphorus, potassium, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, zinc) for unspecified indication and start and stop date was not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for Covid-19.The patient had a routine CBC performed and her white blood cells (WBC) count was abnormally high, and she was diagnosed with chronic myeloid leukaemia On 29Jun2021 07:30. On 21Feb2021, patient took both doses and experienced overdose. Adverse event WBC increased and chronic myeloid leukaemia resulted into emergency room/department or urgent care. Patient was hospitalized for 4 days. Treatment included for adverse event WBC increased and chronic myeloid leukaemia was chemotherapy. The patient underwent lab tests and procedures which included full blood count: WBC count was abnormally high on jun2021, WBC count was abnormally high and was diagnosed with chronic myeloid leukaemia, since the vaccination, the patient had been tested for COVID-19. sars-cov-2 test: negative on 29Jun2021 nasal swab. The outcome of event was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event chronic myeloid leukaemia . 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.