Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chronic obstructive pulmonary disease, Coronary arterial stent insertion, Thrombosis
Clinical narrative: heart catheterization; stint placed in heart; Clot blood; Chronic obstructive pulmonary disease; This is a solicited report received from a contactable consumer (patient) based (FACILITATED COLLECT) on the information received by Pfizer from AbbVie Inc. (MFR control no.: 21K-163-4064157-00). A 69-year-old male patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 69-years-old), dose 1 intramuscular on 27Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 intramuscular on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; and upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included ongoing tobacco user; covid-19, atrial fibrillation and pneumonia in Nov2020; patient was hospitalized. The patient's concomitant medications were not reported. The patient experienced clot blood on an unspecified date with outcome of unknown; had a heart catheterization and stint placed in heart on an unknown date in 2021 with outcome of unknown; and Chronic obstructive pulmonary disease in 2021 with outcome of not recovered. Further description stated that the 69 year-old-male patient with events of COVID-19, atrial fibrillation, heart catheterization, stent placed in heart and pneumonia and non-serious chronic obstructive pulmonary disease due to cigarettes, blood clot and patient has Stint with RINVOQ (UPADACITINIB). On unknown dates, the patient experienced blood clot and patient had stint. In Nov2020, the patient experienced COVID-19, atrial fibrillation and pneumonia. In 2021, the patient experienced heart catheterization, stent placed in heart and chronic obstructive pulmonary disease due to cigarettes. PFIZER  BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was recently hospitalized for heart catheterization, and stint placed in heart, prescribed two blood thinners.In Nov2020, he was hospitalized for covid, pneumonia, developed atrial fibrillation from covid. He was hospitalized and paused drug until end of Dec2020. Ongoing chronic obstructive pulmonary disease due to cigarettes. Adverse event information was provided by patient related to covid vaccine. He had taken Eloquis (as reported) for blood clotting. It was stated that they discussed FDA findings related to drug with psoriatic arthritis treating with Eloquis and had stint. Also his wife had covid in Dec2020. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 27Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 20Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with ELIQUIS. Therapeutic measures were taken as a result of clot blood. The action taken in response to upadacitinib was unknown.  Causality for RINVOQ (upadacitinib): The reporters causality for the event(s) of Covid-19, Heart catheterization, Stent placed in heart, pneumonia, Chronic obstructive pulmonary disease due to cigarettes and patient has Stint was not provided. The reporters causality for the event(s) of Atrial fibrillation with RINVOQ (upadacitinib) was no reasonable possibility. The reporters causality for the event(s) of Blood clot with RIN-VOQ (upadacitinib) was a reasonable possibility. AbbVies opinion is that there is no reasonable possibility that the events of COVID-19, Atrial fibrillation, heart catheterization, Stent placed in heart, Pneumonia, Chronic obstructive Pulmonary disease due to cigarettes and patient has stint are related to RIN-VOQ (UPADACITINIB). AbbVies opinion is that the event of Blood clot is not assessable.   Causality for PFIZER BIONTECH COVID-19 VACCINE for the events cardiac catheterization, coronary stent placement, chronic obstructive pulmonary disease and clot blood was not provided.  Change History: On 27Sep2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "Covid-19 ", "Atrial fibrillation", "Chronic obstructive pulmonary disease due to cigarettes" and "Pneumonia" were added. On 13Oct2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug in-formation, treatment drug information and narrative description. The events of "Blood clot" and "patient has Stint" were added.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to Thrombosis , Catheterisation cardiac, Coronary arterial stent insertion, Chronic obstructive pulmonary disease cannot be excluded.  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.