Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Diabetes mellitus, Gastrointestinal haemorrhage, Investigation
Clinical narrative: Gastrointestinal bleed; Diabetic; Uveitis flare up/non-infectious intermediate posterior and panuveitis progressed; liver enzymes not acceptable/high/alanine aminotransferase elevated; 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-163-4476515-00 (Company).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free,1 in 2 wk), subcutaneous for uveitis; methotrexate (METHOTREXATE), (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset Apr2022, outcome "unknown", described as "liver enzymes not acceptable/high/alanine aminotransferase elevated"; GASTROINTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Gastrointestinal bleed"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetic"; UVEITIS (medically significant), outcome "unknown", described as "Uveitis flare up/non-infectious intermediate posterior and panuveitis progressed". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (Feb2022) Normal; (Apr2022) Elevated at 39; (08Jul2022) At 59; liver enzymes: (unspecified date) not acceptable, notes: the patient experienced liver enzymes not acceptable/high/alanine; (unspecified date) high, notes: the patient experienced liver enzymes not acceptable/high/alanine. The action taken for adalimumab and methotrexate was unknown. Therapeutic measures were taken as a result of diabetes mellitus.  Clinical Course: Solicited report from by a consumer of a 62-year-old male with events of gastrointestinal bleed and non-serious diabetic, liver enzymes not acceptable/high/alanine aminotransferase elevated and non-infectious intermediate posterior and panuveitis progressed with Humira (Adalimumab). there was no reported medical history. On unknown dates, the patient experienced gastrointestinal bleed, diabetic and non-infectious intermediate posterior and panuveitis progressed. In Apr2022, the patient experienced liver enzymes not acceptable/high/alanine. Aminotransferase Elevated. Methotrexate And Pfizer Biontech Covid-19 Vaccine (Tozinameran) were also considered suspect. The patient liver enzymes were not acceptable and were high. He said it could be from the Methotrexate. He was diabetic and was taking guniva after he started taking it his lsp got high. So, his physician wanted him to start taking HUMIRA weekly instead of biweekly. He was progressing with his disease where he noticed that floaters were coming back. He did not take any concomitant drugs. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. The patient had no Known Allergies and no relevant medical history  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of gastrointestinal bleed, diabetic, liver enzymes not acceptable/high/alanine aminotransferase elevated and uveitis flare up/non-infectious intermediate posterior and panuveitis progressed was not provided.  Company's opinion is that the event of gastrointestinal bleed is not assessable. Company's opinion is that there is no reasonable possibility that the events of diabetic, liver enzymes not acceptable/high/alanine aminotransferase elevated and non-infectious intermediate posterior and panuveitis progressed are related to Humira(Adalimumab). Dechallenge: N/A.  Causality for Methotrexate(Methotrexate): The reporter's causality for the event(s) of gastrointestinal bleed, diabetic and uveitis flare up/non-infectious intermediate posterior and panuveitis progressed was not provided and probable for liver enzymes not acceptable/high/alanine aminotransferase elevated. Dechallenge: N/A.  Causality for BNT162b2: The reporter's causality for the event(s) of gastrointestinal bleed, diabetic, liver enzymes not acceptable/high/alanine aminotransferase elevated and non-infectious intermediate posterior and panuveitis progressed was possible.  The reporter considered "gastrointestinal bleed", "diabetic", "uveitis flare up/non-infectious intermediate posterior and panuveitis progressed" and "liver enzymes not acceptable/high/alanine aminotransferase elevated" related to BNT162b2.  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 information, the reported events "gastrointestinal bleed", "diabetic", "uveitis flare" and "alanine aminotransferase increased" cannot be excluded for the suspect drug. The follow-up information received does not alter the previous company clinical evaluation. 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.