Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: bruises easily; Tired; reaction to second COVID booster became red and hard; reaction to second COVID booster became red and hard; positive for COVID; positive for COVID; 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-4129680.  A 72-year-old female patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; ibrutinib (IMBRUVICA), (Lot number: 1157037), oral for chronic lymphocytic leukaemia. The patient's relevant medical history included: "Shoulder Issues", start date: 2021 (not ongoing), notes: had shoulder surgery after five years of having issues. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE INDURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 01Jun2022, outcome "recovered" (2022) and all described as "reaction to second COVID booster became red and hard"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "positive for COVID"; INCREASED TENDENCY TO BRUISE (non-serious), outcome "recovered", described as "bruises easily"; FATIGUE (non-serious), outcome "recovered", described as "Tired". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) Positive; (Jun2022) Positive. The action taken for ibrutinib was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19, vaccination site induration, increased tendency to bruise, fatigue, vaccination site erythema.  Clinical course: Solicited report from the country by a consumer with events of Shoulder Issues, and non-serious reaction to second COVID booster became red and hard, bruises easily, Tired, positive for COVID, reaction to second COVID booster became red and hard and positive for COVID with Ibrutinib Film-Coated Tablet. On 2017, the patient experienced Shoulder Issues. On Sep2021, the patient experienced positive for COVID. On Jun2022, the patient experienced reaction to second COVID booster became red and hard. On Jun2022, the patient experienced reaction to second COVID booster became red and hard. On Jun2022, the patient experienced positive for COVID. On unknown date(s), the patient experienced Tired, bruises easily. Pfizer/BioNTech was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient reported had shoulder surgery after five years of having issues. She had tried no surgical such as physical therapy and cortisone shot. She was tested positive for COVID in Sep2021 and Jun2022. On 01Jul2022 she had shoulder surgery. She was on physical therapy at the time of report. She had reaction to second COVID booster became red and hard. She had sometimes tired. She received gamma globulin infusions. The patient was treated with Cortisone Acetate. COVID test [COVID-19 virus test], Jun2022, Positive and COVID test [COVID-19 virus test], Sep2021, Positive. Causalities: The reporter's causality for the event(s) of Shoulder Issues with Ibrutinib Film-Coated Tablet was No Reasonable Possibility. The reporter's causality for the event(s) of positive for COVID onset Sep2021, reaction to second COVID booster became red and hard onset 01Jun2022, reaction to second COVID booster became red and hard onset 01Jun2022, positive for COVID onset 01Jun2022 and Tired with Ibrutinib Film-Coated Tablet was Reasonable Possibility. The reporter's causality for the event(s) of bruises easily with Ibrutinib Film-Coated Tablet was Not Provided. The reporter's causality for the event(s) of Shoulder Issues, positive for COVID onset Sep2021, positive for COVID onset 01Jun2022, Tired and bruises easily with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of reaction to second COVID booster became red and hard onset 01Jun2022 and reaction to second COVID booster became red and hard onset 01Jun2022 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Company's opinion was that the causality for the event(s) of Shoulder Issues, positive for COVID onset Sep2021, reaction to second COVID booster became red and hard onset 01Jun2022, reaction to second COVID booster became red and hard onset 01Jun2022 and positive for COVID onset Jun2022 with Ibrutinib Film-Coated Tablet was No Reasonable Possibility. Company's opinion was that the causality for the event(s) of Shoulder Issues, positive for COVID onset Sep2021, reaction to second COVID booster became red and hard onset 01Jun2022, reaction to second COVID booster became red and hard onset 01Jun2022, positive for COVID onset Jun2022, Tired and bruises easily with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Company's Alternative Etiology for Shoulder Issues with Ibrutinib Film-Coated Tablet: More likely increased risk from elderly age in this female patient. Company's Alternative Etiology for positive for COVID with Ibrutinib Film-Coated Tablet: Event more likely related to pandemic outbreak of SARS COV-2 in an elderly patient with underlying CLL. Company's Alternative Etiology for reaction to second COVID booster became red and hard with Ibrutinib Film-Coated Tablet: More likely a reaction to COVID booster Company's Alternative Etiology for reaction to second COVID booster became red and hard with Ibrutinib Film-Coated Tablet: More likely a reaction to COVID booster. Company's Alternative Etiology for positive for COVID with Ibrutinib Film-Coated Tablet: Event more likely related to pandemic outbreak of SARS COV-2 in an elderly patient with underlying CLL. Assessment Results were reported as- Imbruvica - Arthropathy, unspecified, involving shoulder region, Non-Health Care Professional, Global Introspection, Not Related, Imbruvica - Arthropathy, unspecified, involving shoulder region, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility. Imbruvica - COVID-19 virus test positive, Non-Health Care Professional, Global Introspection, Probable, Imbruvica - COVID-19 virus test positive, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility. Imbruvica - Vaccination site induration, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility, Imbruvica - Vaccination site induration, Non-Health Care Professional, Global Introspection, Probable. Imbruvica - Vaccination site erythema, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility, Imbruvica - Vaccination site erythema, Non-Health Care Professional, Global Introspection, Probable Imbruvica - Tiredness, Market Authorization Holder (MAH), Global Introspection, Not assessable, Imbruvica - Tiredness, Non-Health Care Professional, Global Introspection, Probable. Imbruvica - Tendency to bruise easily, Market Authorization Holder (MAH), Global Introspection, Not assessable. Imbruvica - Tendency to bruise easily, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech - COVID-19 virus test positive, Market Authorization Holder (MAH), Pfizer/BioNTech - COVID-19 virus test positive, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech - Tendency to bruise easily, Market Authorization Holder (MAH), Pfizer/BioNTech - Tendency to bruise easily, Non-Health Care Professional, Global Introspection, Not Reported.  Pfizer/BioNTech - Vaccination site induration, Market Authorization Holder (MAH),  Pfizer/BioNTech - Vaccination site induration, Non-Health Care Professional, Global Introspection, Possible. Pfizer/BioNTech - Arthropathy, unspecified, involving shoulder region, Market Authorization Holder (MAH), Pfizer/BioNTech - Arthropathy, unspecified, involving shoulder region, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech - Vaccination site erythema, Market Authorization Holder (MAH), Pfizer/BioNTech - Vaccination site erythema, Non-Health Care Professional, Global Introspection, Possible. Pfizer/BioNTech - Tiredness, Market Authorization Holder (MAH), Pfizer/BioNTech - Tiredness, Non-Health Care Professional, Global Introspection, Not Reported.  The reporter's assessment of the causal relationship of "positive for covid", "bruises easily" and "tired" with the suspect product(s) 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. The reporter considered "reaction to second covid booster became red and hard" related to BNT162b2.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.