Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
evans syndrome following RSV Vaccination; This serious case was reported in a literature article and described the occurrence of evans syndrome in a 66-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Literature Reference. Concurrent medical conditions included hypertension, hyperlipidemia and lung nodule. Additional patient notes included patient denied any history of recent infections, fever, recent travel, sick contacts, prior history of platelet disorders, or known autoimmune disease, or family history of platelet or bleeding disorders. Concomitant products included amlodipine, losartan and hydrochlorothiazide. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced evans syndrome (Verbatim: evans syndrome following RSV Vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins, dexamethasone, rituximab and prednisone. The outcome of the evans syndrome was resolving. The reporter considered the evans syndrome to be related to RSV vaccine. The company considered the evans syndrome to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date 08-DEC-2025. Author reported a patient with a history of hypertension and hyperlipidemia presented to the hospital with a new-onset petechial rash involving patient's arms, legs, and face. Labs showed a platelet count of 2 x 10e9/L, which was previously normal. The patient denied any history of recent infections, fever, recent travel, sick contacts, prior history of platelet disorders, or known autoimmune disease, or family history of platelet or bleeding disorders. Patient's home medications included amlodipine, losartan, hydrochlorothiazide, and patient reported receiving the RSV vaccine one week before admission. Repeat workup showed a WBC of 5.4 x 10e9/L, HB of 14.3 g/dL, and a severely reduced platelet count of 1 x 10e9/L, with a normal chemistry panel. HIV and hepatitis panels were negative. The patient was started on presumed ITP treatment with a 1g/kg dose of IVIG and high-dose dexamethasone 40 mg for 4 days. However, on hospital day 4, the hemoglobin level began to decline from 14.3 to 9.9 g/dL. This was followed by a sudden increase in total bilirubin, low haptoglobin, and elevated LDH, a positive Direct antiglobulin test for IgG (C3d negative), which raised concern for the development of hemolytic anemia. Further serologic testing showed an ANA titer of 1:80 with a cytoplasmic pattern and 1:40 with a nuclear homogenous pattern. CMV IgG positive, positive EBV IgG, and negative IgM. Cardiolipin IgG less than 2.0, IgM less than 2.0. The hematopathology did not show definitive immunophenotypic evidence of a hematolymphoid neoplasm. A bone marrow biopsy revealed a hypercellular marrow with a 65percent cellularity, characterized by an increased immature megakaryocyte fraction that was not clustered and a normal karyotype. Full-body CT scan reported known lung nodules, unchanged from previous studies, and showed no evidence of lymphadenopathy. Due to refractory thrombocytopenia, the treatment was shifted to rituximab after the development of hemolytic anemia. The patient received a total of 4 doses weekly, along with a prednisone taper starting at 1 mg/kg, resulting in a slow improvement in patient's counts back to normal. this was the first case documented of Evans syndrome secondary to RSV vaccination. The hospital course, lack of alternative etiologies, and temporal association were consistent with cases of vaccine-associated Evans syndrome reported after receiving other vaccinations.; Sender's Comments: A case of Evans syndrome, unknown time after receiving RSV vaccine, in a 66-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (known autoimmune disease, h/o platelet disorders, family history of platelet disorders).
Hyperlipidemia; Hypertension; Lung nodule
Comments: patient denied any history of recent infections, fever, recent travel, sick contacts, prior history of platelet disorders, or known autoimmune disease, or family history of platelet or bleeding disorders
AMLODIPINE; LOSARTAN; HYDROCHLOROTHIAZIDE
Test Name: total bilirubin; Result Unstructured Data: (Test Result:sudden increased,Unit:unknown,Normal Low:,Normal High:); Test Name: IgM; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: IgM; Result Unstructured Data: (Test Result:less than 2,Unit:unknown,Normal Low:,Normal High:); Test Name: LDH; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Name: Cardiolipin IgG; Result Unstructured Data: (Test Result:less than 2,Unit:unknown,Normal Low:,Normal High:); Test Name: C3d; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Direct antiglobulin test; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Name: CMV IgG; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Name: EBV IgG; Result Unstructured Data: (Test Result:Positive,Unit:unknown,Normal Low:,Normal High:); Test Name: HB; Result Unstructured Data: (Test Result:14.3,Unit:g/dL,Normal Low:,Normal High:); Test Name: HB; Result Unstructured Data: (Test Result:9.9,Unit:g/dL,Normal Low:,Normal High:) on hospital day 4; Test Name: haptoglobin; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:); Test Name: hepatitis panels; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: HIV panel; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: chemistry panel; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:2 x 10e9/L,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:previously normal,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:severely reduced 1 x 10e9/L,Unit:unknown,Normal Low:,Normal High:); Test Name: WBC; Result Unstructured Data: (Test Result:5.4 x 10e9/L,Unit:unknown,Normal Low:,Normal High:); Comments: On unknown date serologic testing showed an ANA titer of 1:80 with a cytoplasmic pattern and 1:40 with a nuclear homogenous pattern. On unknown date the hematopathology did not show definitive immunophenotypic evidence of a hematolymphoid neoplasm. On unknown bone marrow biopsy revealed a hypercellular marrow with a 65% cellularity, characterized by an increased immature megakaryocyte fraction that was not clustered and a normal karyotype. Full-body CT scan reported known lung nodules, unchanged from previous studies, and showed no evidence of lymphadenopathy.