Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Illness, Prostatic specific antigen increased, Pulmonary fibrosis
Clinical narrative: scarring in lungs; elevated prostatic specific antigen; sick;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4453153-00.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "scarring in lungs"; PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "not recovered", described as "elevated prostatic specific antigen"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: Blood test: Elevated prostate specific antigen, notes: Unknown date Blood test: Elevated prostate specific antigen; Elevated prostate specific antigen, notes: Unknown date Blood test: Elevated prostate specific antigen. The action taken for upadacitinib was unknown.  The reporter considered "scarring in lungs" related to BNT162b2. The reporter's assessment of the causal relationship of "elevated prostatic specific antigen" and "sick" 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.  Clinical course: the reporter reported that the patient with events of scarring in lungs and non-serious elevated prostatic specific antigen and covid-19 with RINVOQ (upadacitinib). There was no reported medical history. On unknown dates, the patient experienced scarring in lungs and elevated prostatic specific antigen. In 2021, the patient experienced covid-19. On an unknown date, covid-19 resolved with sequelae. Pfizer Biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had high prostate specific antigen levels in two different tests. In late Aug or early Sep 2021, he had covid-19. He was very sick and had some scarring in his lungs. He did not agree to have physician contacted. It was unknown if patient was enrolled in covid-19 vaccine trial. Causality for RINVOQ (upadacitinib): the reporter's causality for the event(s) of scarring in lungs and covid-19 was not provided. The reporter's causality for the event(s) of elevated prostatic specific antigen with RINVOQ (upadacitinib) was a reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of scarring in lungs and covid-19 are related to RINVOQ (Upadacitinib). Company's opinion is that the event of elevated prostatic specific antigen is not assessable. Relevant Laboratory & Other Diagnostic Tests: Unknown date BLOOD TEST: Elevated prostate specific antigen. Unknown date BLOOD TEST: Elevated prostate specific antigen. Change History: On 30Jun2022, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of SCARRING IN LUNGS and COVID-19 were added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 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.