Report #2882018

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

AIH in remission who experienced a flare 2 weeks after her second Pfizer dose, requiring increased immunosuppressive therapy; This is a literature report for the following literature source(s). A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for covid-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "AIH in remission who experienced a flare 2 weeks after her second Pfizer dose, requiring increased immunosuppressive therapy". Therapeutic measures were taken as a result of autoimmune disorder.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events AUTOIMMUNE DISORDER and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202600005181 Same article, drug/ different event, patient;