Age: 85.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chronic lymphocytic leukaemia, Lymphocyte count, Lymphocyte count increased, Renal disorder
Clinical narrative: Kidney disorder; Absolute lymphocyte count increased; CLL progression; This is a spontaneous report from a contactable physician. An 85-year-old male patient received the second dose of BNT162B2, intramuscularly on 16Feb2021 at single dose for COVID-19 immunisation, and ibrutinib (IMBRUVICA), orally from an unspecified date to an unspecified date at 420 mg, daily, then from an unspecified date to an unspecified date at 280 mg, daily, and then from 2016 to an unspecified date at 140 mg, daily for chronic lymphocytic leukaemia (CLL). Medical history included minor environmental allergies and chronic lymphocytic leukemia. No drug abuse/illicit drug use, non-smoker, and no alcohol use. Concomitant medications included clonazepam, diphenhydramine hydrochloride (BENADRYL), iodine for supplement, zinc chloride, and quercetin. Patient previously received the first dose of BNT162B2 (COVID-19 Vaccine) on 26Jan2021 for COVID-19 immunisation. The patient experienced CLL progression in Feb2021, kidney disorder (stress on kidney) on an unspecified date, and absolute lymphocyte count increased in Feb2021. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The patient's ibrutinib dose was reduced so that he could take the minimal amount required to reduce stress on his kidney per his physician's instructions. His absolute lymphocyte count stayed stable taking ibrutinib 140 mg daily. His absolute lymphocyte count became elevated after he received his second COVID-19 vaccination. The patient saw his physician on 14May2021. The physician's opinion was that the elevated lymphocyte count was a progression of his disease. The patient asked if it was caused by the COVID-19 vaccine and the physician said it might have but he was unsure. The physician sent in a new prescription for ibrutinib 280 mg daily but the patient had not started taking it yet. The patient underwent lab tests and procedures which included absolute lymphocyte count: 3.5 ul/ml on 10Mar2021, and 5.7 ul/ml on 01May2021. The action taken in response to the events for ibrutinib was unknown. Outcome of event kidney disorder was unknown, and of other events was not resolved.  Causality for ibrutinib: The reporter's causality for the events of progression of CLL, off label dose-280 mg daily, off label dose-140 mg daily, stress on kidney and absolute lymphocyte count became elevated was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  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.