Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy; intraoperative bleeding; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) (seriousness criteria hospitalization and medically significant) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) (seriousness criteria hospitalization and medically significant). The patient was treated with Romiplostim for Secondary immune thrombocytopenic purpura, at an unspecified dose and frequency; Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) for Secondary immune thrombocytopenic purpura, at an unspecified dose and frequency and Surgery (two sub-selective splenic artery embolization and elective robotic splenectomy) for Immune thrombocytopenia. At the time of the report, IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) outcome was unknown and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: platelets rebounded to adequate levels. For mRNA-1273 (Spikevax) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Chronic Immune Thrombocytopenic Purpura/ ITP secondary to the second COVID-19 vaccine and refractory to medical and surgical therapy) and PROCEDURAL HAEMORRHAGE (intraoperative bleeding) to be related. Concomitant medications were not reported. Reported that patient with no significant past medical history presented six days after his second dose of the Moderna COVID-19 vaccine, complaining of diffuse purpura on all extremities, two episodes of melena, dizziness, and fatigue and was diagnosed with immune thrombocytopenic purpura (ITP). ITP was secondary to the second COVID-19 vaccine and refractory to refractory to medical and surgical therapy and patient underwent robotic splenectomy. After failing multiple cycles of high-dose corticosteroids, IVIG (intravenous immunoglobulin), and romiplostim, the patient underwent sub-selective splenic artery embolization (SAE). After 26 months, the spleen retained its size, and he underwent a second sub-selective SAE followed by an elective robotic splenectomy, which converted to an open procedure due to intraoperative bleeding. Seven days post-op, the patient's platelets rebounded to adequate levels, and he was discharged on post-op day eight. The patient had evidence of thrombocytopenia at follow-up on postoperative day 24 that rebounded by postoperative day 66. This patient's unique treatment course highlights various medical and surgical challenges in the armamentarium for patients with ITP.; Reporter's Comments: The event Procedural haemorrhage was considered as not related to the Moderna vaccine as this was a complication presented during the surgery, in the context of the chronic immune thrombocytopenic purpura. The benefit-risk relationship of the product is not affected by this report
Test Name: platelets; Result Unstructured Data: platelets rebounded to adequate levels