Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Asthenia, Deafness unilateral, Feeling abnormal, Urinary tract infection
Clinical narrative: Deafness right ear; Urinary tract infection; Feeling bad; Weakness; This is a solicited report based on the information received by Pfizer.  A 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; ibrutinib (IMBRUVICA), oral from 02Jun2015 (Batch/Lot number was not reported) to an unspecified date, at 140 mg, 3x/day [(140 mg, 3 in 1 D)] for chronic lymphocytic leukaemia; ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 420 mg, 1x/day [420 mg (420 mg, 1 in 1 D)] for Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis The patient had no known medical history    The patient's concomitant medications were not reported.  The patient experienced deafness right ear, urinary tract infection, feeling bad and  weakness. All events involved hospitalization and were medically significant. The patient's hospitalization was prolonged as a result of deafness right ear, urinary tract infection, feeling bad,  weakness. The action taken in response to the event(s) for ibrutinib was permanently withdrawn on an unspecified date , for ibrutinib was dose not changed. The clinical outcome of the events was recovering.  Solicited report by a consumer of an elderly male with events of couldn't hear from right ear and urinary tract infection and non-serious feel crummy and weakened with Imbruvica (Ibrutinib) and Imbruvica (Ibrutinib). There was no reported medical history.  On unknown dates, the patient experienced couldn't hear from right ear, urinary tract infection, feel crummy and weakened. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown. Patient was in hospital for a week and had lots of tests. And came out to being urinary tract infection that made him feel crummy and was weakened. Patient also reported that couldn't hear from right ear it could be from Pfizer vaccine. Which was finished a month ago. And never had much trouble with Imbruvica.  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).    Suspect Drug (s):  Seq.No . : 1 Drug: Imbruvica (capsule) (Ibrutinib), Unknown Daily dose: 420 mg (140 mg, 3 in 1 D) Route of Admin:  Oral Therapy dates/Duration: 02Jun2015-Discontinued Indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Drug discontinued Causalis per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  Unk Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk Feeling bad (Feeling abnormal) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Weakness (Asthenia)  Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk  Seq No.: 2 Drug: Imbruvica (Tablet) (Ibrutinib) Daily dose:  420 mg (420 mg, 1 in 1 D) Route of Admin:  Oral Therapy dates/Duration: Unk-Ongoing  indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A  Seq No.: 3 Drug: COVID-19 Vaccine (COVID-19 Vaccine), Unknown Daily dose:  Pfizer Vaccine Route of Admin:  Intra-muscular Indications for Use: COVID-19 Vaccination  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  The reporter assessment of the causal relationship of the events UTI, Feeling bad and Weakness  with the suspect product BNT162B2 was not provided at the time of this report.  Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the reported  events deafness right ear, urinary tract infection, feeling bad and  weakness are attributed to underlying or intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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.