Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Haemoglobin, Hepatic function abnormal, Infection
Clinical narrative: Lymph nodes cervical swollen; Function liver abnormal; Platelet count abnormal; White blood cell count abnormal; Sinus infection; Bilirubin increased; Rash aggravated; Blistery rash; Ministroke; Function liver decreased; Dry skin; Open wound; Localized infection; Leg infection; Pain; Digestion impaired; Feeling unwell; Cramps; Infection; Redness; This is a non-interventional study (solicited report) received from consumer (patient) based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3964269-00).  A 55-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via intramuscular route of administration on 24Aug2021 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. The patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via intramuscular route of administration on 03Aug2021 as dose 1, single (at the age of 55-years-old) for COVID-19 immunization and received ibrutinib (Imbruvica, tablet, Batch/Lot number and Expiration date was not reported), from an unspecified date in 2021 to 25Oct2021, at a dose of 420 mg, 1x/day via oral route, from 18Aug2020 (Batch/Lot number and Expiration date was not reported) to an unspecified date, at a dose of 280 mg, 1x/day via oral route, from 18Aug2020 (Batch/Lot number and Expiration date was not reported) to 20May2021, at a dose of 280 mg, 1x/day via oral route and from 21Jun2021 (Batch/Lot number and Expiration date was not reported) and ongoing, at a dose of 280 mg, 1x/day via oral route for chronic lymphocytic leukemia (CLL). Patient had no medical history and had no known allergies. Patient did not receive any concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. On an unspecified date in 2021, patient had TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 2021, described as "Ministroke"; patient's liver functions were 1.8 and now 0.07, had dry skin that opened into small wounds, no immune response from COVID-19 first vaccine dose/vaccine response impaired, liver function abnormal, rash four times worse/rash on face, neck and hands were worse/rash like ant bites/rash aggravated, rash looks like blisters that pop up, digestive issues/digestion impaired, bilirubin up, not feeling well/feeling unwell, cramping, infections and redness. On an unspecified date of 2021, patient experienced sinus infection, infection on left rib/localized infection, infection to the left leg/leg infection, that looked like a blood clot and pain. On 20May2021, patient experienced high bilirubin levels at 1.8/bilirubin increased. On Jun2021, patient experienced three swollen lymph nodes under the neck/lymph nodes cervical swollen, function liver abnormal, platelets were 190/platelet count abnormal and white blood cell count was 5.5 thousands/white blood cell count was at 6. The patient was treated with Potassium, Gatorade Zero and Emuaid. The patient underwent lab tests and procedures which included blood bilirubin was up on an unspecified date, blood bilirubin was increased  on an unspecified date, blood bilirubin was 1.8 on an unspecified date, blood test was normal   on an unspecified date, hemoglobin was normal on Jun2021, liver function test was 0.07 (no units) on an unspecified date, liver function test was 1.8 (no units) on an unspecified date, liver function test was decreased on an unspecified date, liver function test was abnormal on an unspecified date, liver function test was improved on Jun2021, lymphocyte percentage was normal on Jun2021, platelet count was abnormal on an unspecified date, red blood cell count was normal on Jun2021, white blood cell count was abnormal on an unspecified date, white blood cell count was 5.5 thousand on Jun2021, white blood cell count: 6 (no units) on Jun2021. Blood pressure was going up on an unspecified date. The outcome of function liver decreased and lymph nodes cervical swollen was recovering, unknown for redness, dry skin, open wound, vaccine response impaired, platelet count abnormal, white blood cell count abnormal, recovered for function liver abnormal, rash aggravated, rash aggravated, blistery rash, cramps and infection was all recovered on an unspecified date, bilirubin increased was recovered on 20Jun2021, localized infection and leg infection was recovered on an unspecified date of 2021 and not recovered for rest of the events. Outcome of event ministroke was recovering at the time of report.  The reporter's causality for BNT162b2 for dry skin, open wound, leg infection, localized infection, blistery rash, white blood cell count abnormal, platelet count abnormal, function liver abnormal, pain and redness was not reported and had reasonable possibility for rest of the events.  The reporter's causality for ibrutinib (Imbruvica) for dry skin, open wound, leg infection, localized infection, blistery rash, white blood cell count abnormal, platelet count abnormal, function liver abnormal, pain and redness was not reported and had reasonable possibility for rest of the events.  Drug ibrutinib was discontinued on an unspecified date when patient started treatment with ibrutinib on 18Aug2020 and on an unspecified date, ibrutinib was discontinued again from unknown date to unknown date and now ibrutinib was continued from 21Jun2021 and was ongoing. Causality for IMBRUVICA (IBRUTINIB):  The reporter's causality for the event(s) of liver functions was 1.8 now 0.07, no immune response from covid-19 first vaccine dose, three swollen lymph nodes under the neck, high bilirubin levels at 1.8, rash four times worse/rash on face, neck and hands is worse/rash like ant bites, sinus infection, digestive issues, bilirubin up, not feeling well, cramping, blood pressure was going up, liver enzymes were elevated and hives all over the body with Imbruvica (Ibrutinib) was a reasonable possibility. The reporter's causality for the event(s) of dry skin that opened into small wounds unknown onset, dry skin that opened into small wounds unknown onset, liver function abnormal, platelets at 190, white blood cell count at 5.5 thousands/white blood cell count was at 6, rash looks like blisters that pop up, infection on left rib, infection to the left leg, that looked like a blood clot, pain and redness was not provided Manufacture: opinion is that there is a reasonable possibility that the events of MINI STROKE, LIVER FUNCTIONS WAS 1.8 NOW 0.07, DRY SKIN THAT OPENED INTO SMALL WOUNDS unknown onset, DRY SKIN THAT OPENED INTO SMALL WOUNDS unknown onset, LIVER FUNCTION ABNORMAL, HIGH BILIRUBIN LEVELS AT 1.8, RASH FOUR TIMES WORSE/RASH ON FACE, NECK AND HANDS IS WORSE/RASH LIKE ANT BITES, RASH LOOKS LIKE BLISTERS THAT POP UP, SINUS INFECTION, INFECTION ON LEFT RIB, INFECTION TO THE LEFT LEG, THAT LOOKED LIKE A BLOOD CLOT, PAIN, DIGESTIVE ISSUES, BILIRUBIN UP, NOT FEELING WELL, CRAMPING, INFECTIONS, REDNESS, BLOOD PRESSURE WAS GOING UP, LIVER ENZYMES WERE ELEVATED and HIVESALL OVER THE BODY are related to IMBRUVICA(IBRUTINIB). AbbVie's opinion is that there is no reasonable possibility that the events of NO IMMUNE RESPONSE FROM COVID-19 FIRST VACCINE DOSE, THREE SWOLLEN LYMPH NODES UNDER THE NECK and WHITE BLOOD CELL COUNT AT 5.5 THOUSANDS/WHITE BLOOD CELL COUNT WAS AT 6 are related to IMBRUVICA (IBRUTINIB). AbbVie's opinion is that the event of PLATELETS AT 190 is not assessable.  Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN), Unknown, Unknown. Causality of events for suspect Comirnaty was not reported for all events.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated company causality for event Drug ineffective.  Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Event Vaccine response impaired (Drug ineffective) was deleted.  Follow-up (10Jan2022): This is a solicited follow-up report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Updated Information Included: Lab test (bilirubin, blood pressure) and Event ministroke. Added dates for previous dose of Imbruvica. Added causality of both suspects and narrative updated.  Follow-up attempts completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 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 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.