Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MM9162 | OT / LA |
axillary lymphadenopathy; Dosage text: 1mL; This is a spontaneous report received from a Physician. A 59-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Nov2025 as dose 1, 1 ml single (Lot number: MM9162) at the age of 59 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "common variable immune deficiency" (unspecified if ongoing), notes: autoimmune diseases; can be linked to lymphomas; "disabled" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 19Nov2025, outcome "unknown", described as "Dosage text: 1mL"; LYMPHADENOPATHY (non-serious) with onset 24Nov2025, outcome "not recovered", described as "axillary lymphadenopathy". The event "axillary lymphadenopathy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was diagnosed with axillary lymphadenopathy on 24Nov2025 after having taken Abrysvo (Act-O-Vial presentation). Indication: Common variable immune deficiency. Patient would have to wait until 60 years old, but since immune compromised, insurance covered it and patient was justified to get early and on recommendation. Patient can discuss timing and information regarding diagnosis. Doesn't know of any reports showing correlation. Doesn't know if related. Had the vaccine on 19Nov2025. Patient has doctorate of osteopathic medicine, caller is disabled, not practicing, but has medical training. Had never taken RSV vaccine before. The order was done by gynecologist. Because of the issues, having a follow up screening in 3 months. Sent order to have this axillary ultrasound repeated to see whether sees a change. Medical conditions: As far as pertinent ones, the radiologist is saying autoimmune disease, patient has autoimmune diseases, common variable immune deficiency, which can be linked to lymphomas. Looking at stuff that could be linked to unilateral axillary lymphadenopathy, and autoimmune disease could be common cause. Test results: Biggest thing is that several left axillary lymph nodes demonstrating thickened cortices and diminutive fatty hilum, which can be suspicious for malignancy. Outcome: Ongoing, at that point radiologist and team came in almost saying go for biopsy. The patient had the vaccine 5 days before that, radiologist was like oh glad you said that, could be reactive to the vaccine. Hard to tell. Told to wait 3 months to have imaged. Seems less sore there, there was soreness when putting transducer over axilla. Patient was shocked, didn't realize anything was going on. Will repeat ultrasound in 3 months, so late February.
Medical History/Concurrent Conditions: Common variable immunodeficiency (autoimmune diseases; can be linked to lymphomas); Disability
Test Name: axillary ultrasound; Result Unstructured Data: Test Result:thickened cortices and diminutive fatty hilum; Comments: Biggest thing is that several left axillary lymph nodes demonstrating thickened cortices and diminutive fatty hilum, which can be suspicious for malignancy. Seems less sore; there was soreness when putting transducer over axilla.