Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis C, Hepatitis C antibody, Investigation, Laboratory test, Lymphadenopathy
Clinical narrative: It is suspected that the vaccine also reactivated a preexisting Hep C infection; In early september, I developed systemic lymphadenopathy and lymphedema; In early september, I developed systemic lymphadenopathy and lymphedema; chronic active Epstein-Barr viral infection incited by the second vaccine dose; fatigue; low RBC; low lymphocyte counts; This is a spontaneous report from a contactable pharmacist (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: EW0169) as dose 2, single at the age of 51-years-old for covid-19 immunization. Medical history included asthma. Known allergies: penicillin (PCN), sulfa. No covid prior vaccination. The patient received other medications in two weeks (unspecified). The patient previously took bnt162b2 (Lot Number: ER8729) in arm left on 07Apr2021 for covid-19 immunisation. No other vaccine in four weeks.  The patient developed crushing fatigue following second vaccine dose. Blood tests yielded several abnormalities, including low RBC and lymphocyte counts. By early Aug2021, the blood tests normalized, and the fatigue mostly resolved. In early Sep2021, the patient developed systemic lymphadenopathy and lymphedema. These progressed rapidly, leading him to go to the ER on 16Sep2021. Subsequently, the patient saw multiple specialists and had a plethora of tests performed, including 3 biopsies, multiple CT scans, multiple ultrasounds, and innumerable blood tests. The final diagnosis from his hematologist at hospital was chronic active Epstein-Barr viral infection incited by the second vaccine dose. In addition, an antibody test for hepatitis C came back positive with a quantitative PCR test revealing a low viral load. A repeat viral load test was negative, suggesting the patient cleared the virus. It is suspected that the vaccine also reactivated a preexisting Hep C infection. Adverse events start date was reported as Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the events (also reported AE treatment included multiple testing procedures). No covid tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The event of Hepatitis C Relapse, fatigue, red blood cell count decreased, lymphocyte count decreased, lymphadenopathy, lymphedema, Epstein-Barr virus infection, is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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.