Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Cataract, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: booster; cataract; Fatigue; Low grade fever; Generalized aching; Lymph nodes enlarged; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4205460-00.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; ibrutinib (IMBRUVICA), first regimen oral from 09Aug2021 (Batch/Lot number: unknown) to 2021 at 420 mg (420 mg ( in 1 every other day)) and second regimen oral since 2021 (ongoing) (Batch/Lot number: unknown) for chronic lymphocytic leukaemia. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID;ROSA CANINA]. Vaccination history included: Bnt162b2 (1st dose, Route: Intramuscular), for COVID-19 Immunization, reaction(s): "cataract", "lymph node enlarged"; Bnt162b2 (2nd dose, Route: Intramuscular), for COVID-19 Immunization, reaction(s): "cataract", "lymph node enlarged". The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; CATARACT (medically significant) with onset 2021, outcome "recovered" (2021), described as "cataract"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low grade fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Generalized aching"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Lymph nodes enlarged". The patient underwent the following laboratory tests and procedures: body temperature: (2021) results:unknown. The action taken for ibrutinib was dosage not changed. The patient reported was having all numbers good from last physician appointment from this past Wednesday. The exception was the metric that measures lymph nodes was a little high. The patient had cataract surgery, and he stopped taking Imbruvica one week prior to the procedure and one week after the procedure. He received booster shot for Covid-19 and responded to the shot unlike when he got the first two vaccine doses. He reported he was getting a low grade fever, feeling fatigue, and achy all over after the booster shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for IMBRUVICA(IBRUTINIB),the reporter's causality for the event(s) of CATARACT was not provided. The reporter's causality for the event(s) of LYMPH NODES WAS LITTLE HIGH with IMBRUVICA(IBRUTINIB) was a reasonable possibility. The reporter's causality for the event(s) of FEELING FATIGUE, LOW GRADE FEVER and ACHY ALL OVER with IMBRUVICA(IBRUTINIB) was no reasonable possibility. opinion is that there is no reasonable possibility that the events of CATARACT, LYMPH NODES WAS LITTLE HIGH, FEELING FATIGUE, LOW GRADE FEVER and ACHY ALL OVER are related to IMBRUVICA(IBRUTINIB). Other relevant history: No known allergies. Change History: Amendment to data received on 17 Dec 2021 with changes to company alternative etiology, suspect drug information, concomitant drug information and narrative description. Version 1 created to update the Booster shot regimen in dosing regimen and to update in narrative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.