Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown.  Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product  "BNT162B2" role cannot be completely 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.