Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: B-cell lymphoma, BCL-2 gene status assay, Biopsy, CD20 antigen positive, CD30 expression
Clinical narrative: follicular lymphoma of neck (non Hodgkins); This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULAR LYMPHOMA (follicular lymphoma of neck (non Hodgkins)) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Breast cyst (breast cyst aspiration), Mammogram in 2015, Colonoscopy (colonoscopy with polypectomy) in 2015, Polypectomy (colonoscopy with polypectomy) in 2015, Hormone replacement therapy, Appendectomy, Breast biopsy (breast surgery (benign cyst removal)), Cholecystectomy, Colon polypectomy (colon polyp removal) in 2021, LASIK eye surgery in 2023 and Artificial crown procedure. Concurrent medical conditions included Melanoma in situ since 1980, Hypothyroidism since 2023, Hypercholesteremia since 2008, Gastroesophageal reflux disease since 2008, Cataract (cataract, left eye (2015-ongoing), cataract, right eye (2015), eye surgery right (cataract with intraocular lens) (2015)) since 2015 and Hay fever.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 13-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FOLLICULAR LYMPHOMA (follicular lymphoma of neck (non Hodgkins)) (seriousness criterion medically significant). At the time of the report, FOLLICULAR LYMPHOMA (follicular lymphoma of neck (non Hodgkins)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2024, B-cell lymphoma: Positive. On 16-Feb-2024, BCL-2 gene status assay: Positive. On 16-Feb-2024, Biopsy: enlarged lymph node with large, back-to-back abnormal follicles lacking polarity, tangible body macrophages and mantle zones. On 16-Feb-2024, CD20 antigen positive: Positive. On 16-Feb-2024, CD30 expression: (Negative) with occasional immunoblasts identified.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 13 Mar 2024, 128 days following the administration of the licensed mRNA vaccine, the patient was diagnosed with non-Hodgkin's follicular lymphoma in the neck. An excisional biopsy performed on 16 Feb 2024, revealed an enlarged lymph node characterized by large, abnormal follicles that lacked polarity, as well as an absence of tangible body macrophages and mantle zones. The follicles exhibited a predominance of centrocytes, with a notable presence of larger Centro blasts and mitotic figures. Immunohistochemical analysis showed that the abnormal follicles were positive for CD20, CD10, BCL6, and BCL-2, while background T cells stained positive for CD3 and CD5, with a mixture of CD4 and CD8 positive T cells. Sparse granulocytes were identified as CD15 positive, and CD30 was largely negative, with only a few immunoblasts present. The Ki-67 proliferation index was significantly elevated in the abnormal follicles, estimated at 50 to 60%. Flow cytometry revealed CD10 positive kappa monotypic B cells with high forward angle light scatter, and the overall morphologic and immunophenotypic characteristics were consistent with classic follicular lymphoma, noting that while the Ki-67 index was increased, the centroblasts did not form diffuse sheets in this sample. The treatment medication was not reported by reporter. Reporter causality was not reported.  Company Comment: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported who experienced the unexpected and serious (medically significant) event follicular lymphoma 128 days after an unknown dose of SPIKEVAX 2023-2024 vaccine was administered. It was reported that 128 days following the administration of the vaccine, the patient was diagnosed with non-Hodgkin's follicular lymphoma in the neck. An excisional biopsy performed revealed an enlarged lymph node characterized by large, abnormal follicles that lacked polarity, as well as an absence of tangible body macrophages and mantle zones. The follicles exhibited a predominance of centrocytes, with a notable presence of larger Centro blasts and mitotic figures. Immunohistochemical analysis showed that the abnormal follicles were positive for CD20, CD10, BCL6, and BCL-2, while background T cells stained positive for CD3 and CD5, with a mixture of CD4 and CD8 positive T cells. Sparse granulocytes were identified as CD15 positive, and CD30 was largely negative, with only a few immunoblasts present. The Ki-67 proliferation index was significantly elevated in the abnormal follicles, estimated at 50 to 60%. Flow cytometry revealed CD10 positive kappa monotypic B cells with high forward angle light scatter, and the overall morphologic and immunophenotypic characteristics were consistent with classic follicular lymphoma, noting that while the Ki-67 index was increased, the centroblasts did not form diffuse sheets in this sample. Outcome of event was reported as unknown.  No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.