Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhagic diathesis, Increased tendency to bruise, Stomatitis
Clinical narrative: Bleed easy; Tired; Sores in mouth; Bruise easy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4150495.  A 64-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), (Batch/Lot number: unknown), oral for chronic lymphocytic leukaemia. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HAEMORRHAGIC DIATHESIS (medically significant), outcome "unknown", described as "Bleed easy"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; STOMATITIS (non-serious), outcome "unknown", described as "Sores in mouth"; INCREASED TENDENCY TO BRUISE (non-serious), outcome "unknown", described as "Bruise easy". The action taken for ibrutinib was unknown.  Clinical course: It was reported that patient had no reported medical history. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Did reaction abate after stopping drug was Not applicable. Did reaction reappear after reintroduction was Not applicable.  Causality: The reporter's causality for the event(s) of Bleed easy, Bruise easy, Sores in mouth and Tired with Ibrutinib was Not Provided. The reporter's causality for the event(s) of Bleed easy, Bruise easy, Sores in mouth and Tired with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  Agency's opinion was that the causality for the event(s) of Bleed easy, Bruise easy, Sores in mouth and Tired with Ibrutinib was Not Provided. Agency's opinion was that the causality for the event(s) of Bleed easy, Bruise easy, Sores in mouth and Tired with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: Imbruvica - Tiredness, Bleeding tendency, Tendency to bruise easily and Sores mouth, Non-Health Care Professional, Global Introspection, Not Reported. Imbruvica - Tiredness, Bleeding tendency, Tendency to bruise easily and Sores mouth, agency.  Pfizer/BioNTech - Tiredness, Bleeding tendency, Tendency to bruise easily and Sores mouth, Non-Health Care Professional, Global Introspection, Possible. Pfizer/BioNTech - Tiredness, Bleeding tendency, Tendency to bruise easily and Sores mouth, agency.  The reporter considered "bleed easy", "tired", "sores in mouth" and "bruise easy" related to BNT162b2.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Haemorrhagic diathesis, Fatigue, Stomatitis, Increased tendency to bruise and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.