Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
active hemolysis/Breakthrough Hemolysis Associated With COVID-19 Vaccination/recurrent Breakthrough haemolysis; This is a literature report for the following literature source(s). This literature case received on 05-MAY-2025, with additional information received on 07-MAY-2025, was reported by a physician, and concerned a patient in (redacted). The case describes the occurrence of Breakthrough haemolysis, recurrent Breakthrough haemolysis, Covid-19, blood lactate dehydrogenase increased, Haemoglobin decreased. The case concerned a 29 Years old, female patient. The patient's medical history included pregnancy in year 2013, at age of 20. At that time, she was noted to have a platelet count of 23,000 and was initially diagnosed with immune thrombocytopenic purpura (ITP). In the subsequent years, the patient was unresponsive to steroid and intravenous immunoglobin (IVIG) therapy. Her diagnosis was modified to PNH in 2017. In 2017, eculizumab therapy was initiated. In February of 2021, maintenance of eculizumab was no longer effective as the patient developed symptomatic disease activity characterized by severe, worsening fatigue, brain fog, chest pain, and active hemolysis. Past drug history included Eculizumab from 2017 to 2021 for PNH (paroxysmal nocturnal hemoglobinuria). On an unknown date in FEB-2021, the patient started pegcetacoplan under an expanded access protocol, at an unspecified dose, route and frequency for an unspecified duration. The product was indicated for PNH (paroxysmal nocturnal hemoglobinuria). The last dose administered was on an unknown date. On an unknown date in JUL-2021, the patient received co-suspect product Pfizer SARS-CoV-2 vaccine, 1st dose, at an unspecified dose, route and unspecified frequency and on an unknown date in AUG-2021, received Pfizer SARS-CoV-2 vaccine, 2nd dose (unknown dose route and frequency). In JUL-2021, the patient received her first dose of the Pfizer SARS-CoV-2 vaccine. She subsequently developed fatigue, lethargy, and evidence Her condition improved to near remission level with a resolution of fatigue, lethargy, and hemolysis approximately one week after the first vaccination. In AUG-2021, the patient received her second dose of Pfizer SARS-CoV-2 vaccine and similar symptoms developed, accompanied by active hemolysis (lactate dehydrogenase (LDH) 783 U/L and a drop in hemoglobin to 7.6 gm/dL). Subsequent to her receiving the second Pfizer SARS-CoV-2 vaccine, the symptoms outlined above slowly improved but nevertheless persisted, accompanied by continued low-grade hemolysis. In JAN-2022, the patient tested seropositive for COVID-19. At that point, she was short of breath (SOB), experiencing exertional chest pain, bleeding from her gums upon brushing her teeth, and easy bruising. Her LDH was 1056 U/L, and her hemoglobin was 6.1 g/d. Platelet and RBC transfusions were administered over two weeks. Her LDH and hemoglobin have yet to fully stabilize to previous baseline levels since the completion of her Pfizer SARS-CoV-2 vaccination schedule. In MAY-2022, the patient requires packed RBC transfusions every two to three months and has undergone a bone marrow transplant evaluation. The patient did not retest following initial seropositivity testing for COVID-19; however, any symptoms directly related to COVID-19 infection have resolved. Breakthrough haemolysis, blood lactate dehydrogenase increased, and Haemoglobin decreased were Requiring Intervention. The action taken with pegcetacoplan was unknown. On an unknown date, the 1st occurrence of events Breakthrough haemolysis had resolved. The outcome for the recurrent Breakthrough haemolysis, blood lactate dehydrogenase increased, Haemoglobin decreased was not resolved. Outcome for Covid-19 was resolved on an unknown date. Relevant lab tests (normal ranges are provided in parenthesis if available): In 2023, Lab Test for Platelet count with range (unknown low - unknown high): unknown result 23,000. On an unknown date, Lab Test for Blood lactate dehydrogenase with range (unknown low - unknown high): result 200s U/L, in Aug-2021 result was 783 U/L and in Jan-2022 result was: 1056 U/L. On an unknown date in Aug-2021, Lab Test for Haemoglobin with range (unknown low - unknown high): result was 7.6 gm/dL and in Jan-2022, result was 6.1 g/d. Company comment: The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to have an unknown relationship to pegcetacoplan. The reporter assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased to be related to Pfizer SARS-CoV-2 vaccine. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), blood lactate dehydrogenase increased, and Haemoglobin decreased as not related to pegcetacoplan, and can be plausibly explained by the underlying paroxysmal nocturnal hemoglobinuria triggered by the administration of COVID-19 vaccine. Apellis assessed Covid-19 as not related to pegcetacoplan since it can be considered as an intercurrent condition with an infectious etiology which is common in the general population. Apellis assessed Breakthrough haemolysis (1st and 2nd occurrence), Covid-19, blood lactate dehydrogenase increased, and Haemoglobin decreased as related to Pfizer SARS-CoV-2 vaccine. The case was deemed as serious due to it requiring intervention.; Sender's Comments: 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.,Linked Report(s) : US-PFIZER INC-PV202500056953 same patient/drug, different event;US-PFIZER INC-PV202500056950 Same reporter/patient/suspect vaccine/event; different dose;
Medical History/Concurrent Conditions: Immune thrombocytopenic purpura; Paroxysmal nocturnal hemoglobinuria; Pregnancy (at age 20)
EMPAVELI
Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result:200s ug/L; Test Name: platelet count; Result Unstructured Data: Test Result:23,000