Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Advanced Mantle Cell Lymphoma/ multi-station LAD consistent with stage IV disease; This serious case was reported in a literature article and described the occurrence of mantle cell lymphoma stage iv in a 72-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Literature Reference. Concurrent medical conditions included colon cancer, lymphadenopathy cervical and weight loss (with lifestyle modifications). Additional patient notes included On the day of endoscopy, patient denied recent changes in patient health. Patient denied fevers, chills, abdominal pain, melena, or hematochezia. On an unknown date, the patient received RSV vaccine. On an unknown date, between 1 and 2 months after receiving RSV vaccine, the patient experienced mantle cell lymphoma stage iv (Verbatim: Advanced Mantle Cell Lymphoma/ multi-station LAD consistent with stage IV disease) (serious criteria GSK medically significant). The patient was treated with bendamustine hydrochloride (Bendamustine) and rituximab. The outcome of the mantle cell lymphoma stage iv was resolving. The reporter considered the mantle cell lymphoma stage iv to be possibly related to RSV vaccine. The company considered the mantle cell lymphoma stage iv to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 14-APR-2025 Author reported a 72-year-old male patient was referred for routine colonoscopy. Patient began routine colonoscopies for colon cancer surveillance starting at age 50. Prior findings included a hyperplastic polyp and sigmoid diverticulosis. On the day of endoscopy, patient denied recent changes in patient health but noted cervical LD (Cervical Lymphadenopathy) in the preceding year that improved on serial ultrasounds. Patient denied fevers, chills, abdominal pain, melena, or hematochezia, but reported intentional weight loss of 40 pounds with lifestyle modifications. Patient also reported enrollment in a new adult RSV vaccine trial. On physical exam, there was no abdominal tenderness or organomegaly. Colonoscopy identified multiple polyps including a large 20 mm ileocecal polyp obstructing access to terminal ileum (top left) and diffuse nodular mucosa in the rectum. Biopsies obtained from the ileocecal valve, rectum and ileum showed extensive lymphoid aggregates that were CD201, CD51, CD10-, BCL6-, and CCND11, consistent with multifocal lymphomatous polyposis 20 to MCL. Oncology referral was placed, and urgent PET scan revealed multi-station LAD (Lymphadenopathy) consistent with stage IV disease. The patient completed 3 cycles of bendamustine and rituximab; repeat PET scan showed near resolution of disease at all sites (bottom). Author presented anatypical case of MCL affecting the colon. the patient received RSV trial vaccine 1-2 months prior to initial LD. The RSV vaccines have been linked to intense B-cells activation, and thus acceleration of low-grade or atypical disease course in older adults with MCL was possible.; Sender's Comments: Mantle cell lymphoma stage IV are unlisted event which is considered unrelated to GSK vaccine RSV vaccine
Colon cancer; Lymphadenopathy cervical; Weight loss (with lifestyle modifications)
Comments: On the day of endoscopy, patient denied recent changes in patient health. Patient denied fevers, chills, abdominal pain, melena, or hematochezia
Test Name: colonoscopy screening; Result Unstructured Data: (Test Result:hyperplastic polyp and sigmoid diverticulosis,Unit:unknown,Normal Low:,Normal High:); Test Name: endoscopy; Result Unstructured Data: (Test Result:advanced MCL,Unit:unknown,Normal Low:,Normal High:); Test Name: physical exam; Result Unstructured Data: (Test Result:no abdominal tenderness or organomegaly,Unit:unknown,Normal Low:,Normal High:); Test Name: PET scan; Result Unstructured Data: (Test Result:multi-station LAD consistent withstage IV disease,Unit:unknown,Normal Low:,Normal High:); Comments: Colonoscopy identified multiple polyps including a large 20 mm ileocecal polyp obstructing access to terminal ileum (top left) and diffuse nodular mucosa in the rectum. Biopsies obtained from the ileocecal valve, rectum and ileum showed extensive lymphoid aggregates that were CD201, CD51, CD10-, BCL6-, and CCND11, consistent with multifocal lymphomatous polyposis 20 to Mantle cell lymphoma (MCL).