Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve replacement, Blood pressure measurement, Bone pain, Computerised tomogram, Echocardiogram
Clinical narrative: Bone pain; High blood pressure; sick; aortic valve replacement; Stenosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), first regimen since May2021 (Batch/Lot number: unknown) at 280 mg alternate day (280 mg, alternate day (every 1 days)) and second regimen since 2022 (Batch/Lot number: unknown) at 1 DF cyclic (1 df, cyclic (one capsule for three days and off one day)), all oral for b-cell small lymphocytic lymphoma, chronic lymphocytic leukaemia. The patient's relevant medical history included: "aortic stenosis" (unspecified if ongoing); "heart issues" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: AORTIC VALVE REPLACEMENT (caused and prolonged hospitalization) with onset Apr2022, outcome "unknown"; STENOSIS (non-serious) with onset 2022, outcome "unknown"; BONE PAIN (non-serious), outcome "not recovered"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient was hospitalized and prolonged hospitalization for aortic valve replacement (start date: 2022). The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high; Computerised tomogram: (2022) Stenosis; Echocardiogram: (unspecified date) heart was all good. The action taken for ibrutinib was unknown. Therapeutic measures were taken as a result of hypertension.  Clinical course: Spontaneous report by a consumer of a 72.000 years old female with events of aortic valve replacement, and non-serious Sick, high blood pressure, stenosis and Bone pain with Ibrutinib. The patient had a relevant medical history of aortic stenosis, heart issues. On 2022, the patient experienced high blood pressure. On 2022, the patient experienced stenosis. On Apr2022, the patient experienced aortic valve replacement. On unknown date(s), the patient experienced Bone pain, Sick. Pfizer biontech covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient had a CT scan before the surgery that showed the stenosis and have had a echocardiogram since that shows the heart is all good. Before the procedure her blood pressure was going to high so physician off the Imbruvica for 5 days. She reported that in Apr2022 had aortic valve replacement and was hospitalized for that. Since her procedure, the Physician started one capsule for three days and off one day. Than she would went back and saw how things were going taking it this way. She was now taking small amount of potassium with the blood pressure pill. She felt her bone pain had gotten worse. The patient was not taking any concomitant drugs. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  Causalities: The reporter's causality for the event(s) of stenosis, Bone pain, Sick, high blood pressure and aortic valve replacement with Ibrutinib was Not Provided. The reporter's causality for the event(s) of stenosis, Bone pain, Sick, high blood pressure and aortic valve replacement with Pfizer BioNTech COVID-19 vaccine was Reasonable Possibility opinion was that the causality for the event(s) of SICK with Ibrutinib was Not Assessable opinion was that the causality for the event(s) of Bone pain and high blood pressure with Ibrutinib was Reasonable Possibility  opinion was that the causality for the event(s) of stenosis with Ibrutinib was No Reasonable Possibility opinion was that the causality for the event(s) of aortic valve replacement with Ibrutinib was Not Provided.  Regulatory authority opinion was that the causality for the event(s) of stenosis, Bone pain, Sick, high blood pressure and aortic valve replacement with Pfizer BioNTech COVID-19 vaccine was Not Provided. Regulatory authority Alternative Etiology for stenosis with Ibrutinib: More likely a pre-existing aortic stenosis in this elderly patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.