Report #2897862

Overview

Sex

Male

Age

Age unknown

State

GA

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (12)

Symptom narrative

relapsed ITP/severe relapse of thrombocytopenia, epistaxis, petechial rash and suspected gastrointestinal hemorrhage; relapsed ITP/severe relapse of thrombocytopenia, epistaxis, petechial rash and suspected gastrointestinal hemorrhage; This is a literature report. A 68-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in 2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ITP", start date: 2021 (ongoing); "AIHA", start date: 2021 (unspecified if ongoing); "autoimmune cytopenia", start date: 2021 (unspecified if ongoing); "coronavirus disease 2019" (unspecified if ongoing); "corticosteroid therapy" (unspecified if ongoing), notes: used for AIHA and ITP, responded well to corticosteroid therapy. The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant, life threatening), DISEASE RECURRENCE (hospitalization, medically significant, life threatening) all with onset 2024, outcome "recovering" and all described as "relapsed ITP/severe relapse of thrombocytopenia, epistaxis, petechial rash and suspected gastrointestinal hemorrhage". The events "relapsed itp/severe relapse of thrombocytopenia, epistaxis, petechial rash and suspected gastrointestinal hemorrhage" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Coagulation test: (2024) within normal limits, notes: No clinical concern for disseminated intravascular coagulation or thrombotic microangiopathy; Computerised tomogram head: (2024) Negative for intracranial hemorrhage.; Haemoglobin: (2024) remained stable; Heart rate: (2024) below 40, notes: unit: beats per minute, bradycardia; Additional evaluation: (2024) Unknown results, notes: performed to exclude alternative causes of severe thrombocytopenia; (2024) No signs of infection were identified.; laboratory tests: (2024) showed continued improvement, notes: in platelet counts, and he remained clinically stable; (2024) no relapse of symptoms or need for readmission.; Metabolic function test: (2024) within normal limits; physical examination: (2024) exhibited diffuse petechiae on the upper, notes: and lower extremities, as well as in the oral mucosa. There was mild mucosal bleeding from the nares and mouth; (2024) revealed petechiae on the upper extremities,, notes: torso, and oral mucosa. Mild swelling of the right arm was noted, though no signs of active bleeding were evident; Platelet count: (2024) 0 x10 9/l, notes: severe thrombocytopenia; (2024) remained at 0, notes: During the first 48 h of admission despite transfusions; (2024) 30 x10 9/l, notes: began to rise by hospital day 3; (2024) 3 x10 9/l, notes: suggesting a relapse or incomplete response to previous treatment; (2024) 62 x10 9/l, notes: increasing over the first 48 h of admission; White blood cell count: (2024) leukocytosis observed. Therapeutic measures were taken as a result of immune thrombocytopenia, disease recurrence. Clinical course: A patient presented to the emergency department in late 2024 with a persistent epistaxis, a widespread petechial rash affecting the oral mucosa, torso, and upper extremities, and suspected melena. He denied experiencing associated symptoms, such as fatigue, fever, or other systemic symptoms. The patient had a significant history of ITP and AIHA diagnosed in 2021, which had previously responded well to corticosteroid therapy. The patient had a prior episode of autoimmune cytopenia in 2021 following coronavirus disease 2019 (COVID-19), presenting with similar bleeding symptoms and responding to corticosteroid therapy. While a direct causal relationship between that episode and the current presentation cannot be definitively established, this history suggests a possible predisposition to immune reactivation. There had been no recent infections, medication changes, or known toxin exposures before this presentation. Before arriving at the emergency department, he was evaluated at an urgent care clinic for his recurrent epistaxis. He underwent nasal cauterization by an ear, nose, and throat (ENT) specialist, but the bleeding continued. He also developed new onsets of rash and darker stools during that time. Based on these evolving symptoms, ENT recommended immediate transfer to the emergency department for further evaluation. On physical examination, the patient exhibited diffuse petechiae on the upper and lower extremities, as well as in the oral mucosa. There was mild mucosal bleeding from the nares and mouth. No rectal examination was conducted due to location constraints, but gastrointestinal bleeding was suspected based on patient history and reported stool changes. Initial bloodwork revealed a platelet count of 0 x 109/L, confirming severe thrombocytopenia. Additional evaluation was performed to exclude alternative causes of severe thrombocytopenia. There was no clinical or laboratory evidence of active hemolysis, and the patient's hemoglobin remained stable throughout admission. No signs of infection were identified, and leukocytosis observed during subsequent admissions was attributed to corticosteroid therapy. Coagulation studies and metabolic panel were within normal limits, and there was no clinical concern for disseminated intravascular coagulation or thrombotic microangiopathy. These findings, in conjunction with the patient's history of ITP, supported the diagnosis of relapsed immune thrombocytopenia. Given the critically low platelet count and bleeding symptoms, hematology and oncology specialists were urgently consulted. A presumptive diagnosis of relapsed ITP was made, and treatment was initiated with IVIG at a dose of 1 g/kg (total dose: 70 g), intravenous methylprednisolone 40 mg daily, and two units of platelet transfusions.During the first 48 h of admission, the patient's platelet count remained at 0 x 109/L, despite transfusions, IVIG and corticosteroid therapy, indicating a poor initial response to treatment. He continued to experience epistaxis and petechiae, with no other signs of bleeding and no evidence of major internal hemorrhage. An additional two units of platelets were transfused, with minimal immediate effect. By hospital day 3, following continued immunosuppressive therapy, his platelet count began to rise, reaching 30 x 109/L, and mucosal bleeding had subsided. The patient remained stable and was discharged 4 days after admission, with a prescription for oral prednisone 60 mg daily, to be tapered over 6 weeks. He was advised to avoid high-risk activities, trauma, and a hematology follow-up 2-3 weeks later. The patient was re-presented to the emergency department a week after initial discharge with recurrent thrombocytopenia, epistaxis, petechial rash, severe headache, worsening fatigue, and shortness of breath over the past 3 days. He also reported a new onset of bradycardia, with documented heart rates below 40 beats per minute. A computed tomography (CT) scan of the brain was performed, which was negative for intracranial hemorrhage. Repeat laboratory testing revealed a platelet count of 3 x 109/L, suggesting a relapse or incomplete response to previous treatment. Physical examination revealed petechiae on the upper extremities, torso, and oral mucosa. Mild swelling of the right arm was noted, though no signs of active bleeding were evident. The patient was managed with one unit of platelet transfusion, IVIG (Privigen) was administered at 1 g/kg for two doses, alone with an initial intravenous dexamethasone 10 mg, followed by tapering doses. The response to platelet transfusion alone was limited; however, following combined therapy with IVIG and corticosteroids, the patient demonstrated a favorable response, with platelet counts increasing to 62 x 109/L over the first 48 h of admission. He was discharged with a resolution of his headache and stabilization of mucosal symptoms. He was advised to report any recurrence of bleeding, fatigue, or neurologic symptoms immediately. Pain management was addressed with acetaminophen or prochlorperazine as needed for residual headaches. At his follow-up visit with hematology, laboratory tests showed continued improvement in platelet counts, and he remained clinically stable. Plans for continued tapering of prednisone and hematology oversight were maintained. As of the 2-week post-discharge period, the patient had no relapse of symptoms or need for readmission. Discussion: This case is clinically significant due to the relapsed ITP that occurred in the context of a recent COVID-19 mRNA vaccination, coupled with the challenge of managing a patient with an autoimmune background and prior history of Evans syndrome. The recurrence of severe thrombocytopenia, epistaxis, petechial rash, and mucosal bleeding despite initial standard therapy highlights the complexity of treatment and the need for a multimodal, carefully coordinated approach to care. This patient, with a background of AIHA and prior ITP, fits into a higher-risk group known to experience frequent relapses and less predictable treatment responses. Notably, this patient demonstrated a relapsing and refractory disease course, requiring multiple hospital admissions within a short time frame despite standard first-line therapies. His limited and transient response to platelet transfusions further supports the immune-mediated destruction characteristic of ITP. The need for escalation to second-line therapy, including planned rituximab, highlights the importance of recognizing patients at risk for chronic or refractory disease and initiating timely advanced therapies. In this case, the patient ultimately responded to a multimodal strategy of repeated IVIG, high-dose steroids, and transfusions for symptomatic management. Importantly, platelet transfusions are generally reserved for cases of life-threatening hemorrhage, as the underlying autoimmune mechanism renders them transient and often ineffective without concurrent immunosuppression. In summary, this case illustrates the complexity of managing relapsed ITP in a patient with a known autoimmune predisposition and recent COVID-19 vaccination. It exemplifies the importance of prompt recognition, the use of a multimodal treatment strategy, and the need for heightened clinical suspicion of autoimmune reactivation in susceptible populations. While the benefits of vaccination overwhelmingly outweigh the risks, this case underscores the necessity of personalized dcare in individuals with prior autoimmune cytopenias. Conclusions: This case is notable for illustrating a suspected vaccine-associated relapse of ITP in a patient with a known history of autoimmune cytopenias. The temporal relationship between COVID-19 vaccination and the recurrence of severe thrombocytopenia, along with the patient's positive response to a timely, multimodal treatment approach, makes this report clinically relevant. It emphasizes the need for heightened clinical awareness of autoimmune disease flares following immunization, particularly in patients with preexisting immune dysregulation. Key lessons from this case include the importance of early recognition and prompt initiation of treatment to prevent serious complications such as mucocutaneous or internal bleeding. It also highlights the necessity for continued monitoring after hospital discharge, as patients with relapsed ITP remain at risk for recurrence despite initial improvement. Clinicians should maintain a high index of suspicion for vaccine-related immune events in similar cases and advocate for individualized follow-up strategies.; Sender's Comments: Based on the available information, the life threatening events IMMUNE THROMBOCYTOPENIA, DISEASE RECURRENCE are possibly related to the suspect drug BNT162b2. 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.

Current illness

Immune thrombocytopenic purpura

Medical history

Medical History/Concurrent Conditions: Autoimmune hemolytic anemia; Coronavirus disease 2019; Cytopenia; Steroid therapy (used for AIHA and ITP, responded well to corticosteroid therapy)

Lab data

Test Date: 2024; Test Name: Coagulation studies; Result Unstructured Data: Test Result:within normal limits; Comments: No clinical concern for disseminated intravascular coagulation or thrombotic microangiopathy.; Test Date: 2024; Test Name: computed tomogphy (CT) scan of the brain; Result Unstructured Data: Test Result:Negative for intracranial hemorrhage.; Test Date: 2024; Test Name: hemoglobin; Result Unstructured Data: Test Result:remained stable; Test Date: 2024; Test Name: heart rates; Result Unstructured Data: Test Result:below 40; Comments: unit: beats per minute, bradycardia; Test Date: 2024; Test Name: Additional evaluation; Result Unstructured Data: Test Result:Unknown results; Comments: performed to exclude alternative causes of severe thrombocytopenia.; Test Date: 2024; Test Name: Examination; Result Unstructured Data: Test Result:No signs of infection were identified.; Test Date: 2024; Test Name: laboratory tests; Result Unstructured Data: Test Result:showed continued improvement; Comments: in platelet counts, and he remained clinically stable.; Test Date: 2024; Test Name: laboratory tests; Result Unstructured Data: Test Result:no relapse of symptoms or need for readmission.; Test Date: 2024; Test Name: metabolic panel; Result Unstructured Data: Test Result:within normal limits; Test Date: 2024; Test Name: physical examination; Result Unstructured Data: Test Result:exhibited diffuse petechiae on the upper; Comments: and lower extremities, as well as in the oral mucosa. There was mild mucosal bleeding from the nares and mouth.; Test Date: 2024; Test Name: Physical examination; Result Unstructured Data: Test Result:revealed petechiae on the upper extremities,; Comments: torso, and oral mucosa. Mild swelling of the right arm was noted, though no signs of active bleeding were evident.; Test Date: 2024; Test Name: platelet count; Result Unstructured Data: Test Result:0 x10 9/l; Comments: severe thrombocytopenia; Test Date: 2024; Test Name: platelet count; Result Unstructured Data: Test Result:remained at 0 x10 9/l; Comments: During the first 48 h of admission despite transfusions; Test Date: 2024; Test Name: platelet count; Result Unstructured Data: Test Result:30 x10 9/l; Comments: began to rise by hospital day 3; Test Date: 2024; Test Name: platelet count; Result Unstructured Data: Test Result:3 x10 9/l; Comments: suggesting a relapse or incomplete response to previous treatment.; Test Date: 2024; Test Name: platelet count; Result Unstructured Data: Test Result:62 x10 9/l; Comments: increasing over the first 48 h of admission; Test Date: 2024; Test Name: WBC; Result Unstructured Data: Test Result:leukocytosis observed