Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy liver abnormal, Hepatitis, Liver function test abnormal
Clinical narrative: This patient was hospitalized on 03Jun2021 with jaundice and hepatitis.; This is a spontaneous report from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation:Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 07May2021  as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included depression, anxiety and insomnia from 2017 and ongoing. The patient has been taking medication for this condition since at least 2017. Concomitant medication included Lurasidone Hydrochloride (LATUDA) taken for depression, anxiety from 2017, Trazodone taken for sleep disorder from 2017 and ongoing; vilazodone hydrochloride (VIIBRYD) taken for an unspecified indication from 2017 and ongoing. The patient experienced jaundice and hepatitis and was hospitalized on 03Jun2021 and his liver biopsy was done and reviewed by another physician who determined the patient's symptoms were related to a drug reaction. Caller is asking if Pfizer has any information on this adverse event being possibly related to the Pfizer BioNTech Covid-19 vaccine. Caller asking that his request be escalated to the drug experts. Response: section 18.1. LAB-1457-9.0. Revised: 19May2021. "Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). Informed caller that my colleagues and I were unable to find any further information regarding this adverse event in relation to the Pfizer BioNTech Covid-19 vaccine. Offered to escalate to second line. Caller states that the patient was hospitalized with jaundice and hepatitis.  States the patient had a liver biopsy, which was sent to (address withheld) for a second opinion.  Their findings showed a drug reaction. When probed about causality the caller stated that the only other possibility for the drug reaction that the liver biopsy showed is the amoxicillin.  He states that however, that medication was stopped 2 months prior to onset of symptoms.  He states there is a closer time frame between the vaccine and her symptoms.  He feels that it is more likely that this was caused by a reaction to the vaccine than a reaction related to the amoxicillin. Caller states that this is all a bit confusing that she has hepatitis without the associated antibodies. States he would like more information on the Covid Vaccine and Hepatitis and other autoimmune issues. The patient lab tests included Liver biopsy: Result: Abnormal and liver function test: abnormal: on Jun2021. The patient was discharged from the hospital on 23Jun2021. The event outcome was Unknown for Liver biopsy and Not recovered for rest of the events.  Communication: The caller was provided with company phone number of #, option 3, and hours of operation, prior to attempted warm transfer. Caller provided with report reference: #. Information on lot/batch number has been requested; Sender's Comments: The event of Hepatitis is assessed as possibly related to the suspect product  BNT162B2  based on strong temporal association, but consider also possible contributory effects from concomitant medications of Trazadone which is known to cause Hepatitis in rare instances.   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.