Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Possible GBS; nasal congestion; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Possible GBS) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Co-suspect products included non-company products RSV vaccine prot. subunit PreF3 (Arexvy) for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Colectomy (UC s/p colectomy) and J-pouch surgery (J pouch and ileoanal anastomosis). Concurrent medical conditions included Diabetes mellitus, Hypertension, Chronic kidney disease stage 3, Ulcerative colitis (UC s/p colectomy), Small bowel obstruction (Multiple SBO) and Cervical disc degeneration. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of RSV vaccine prot. subunit PreF3 (Arexvy) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Possible GBS) (seriousness criteria hospitalization and medically significant) and NASAL CONGESTION (nasal congestion). The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) for Guillain-Barre syndrome, at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Possible GBS) was resolving and NASAL CONGESTION (nasal congestion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Arteriogram carotid: (Negative) head/neck CTA were negative for stroke. On an unknown date, CSF protein: markedly elevated. On an unknown date, CSF red blood cell count: elevated. On an unknown date, CSF white blood cell count: elevated. On an unknown date, Electromyogram: (Negative) negative for acute inflammatory demyelinating polyneuropathy. On an unknown date, Imaging procedure: did not show clear abnormalities. On an unknown date, Magnetic resonance imaging head: (Negative) Negative for stroke. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient was presented to the emergency department (ED) with acute inability to stand or walk. The patient denied recent trauma, confusion and headache. Symptoms quickly progressed to inability to sit-up, problems speaking and swallowing within a few days. Given the progression of motor weakness and the CSF findings, the patient was treated with steroid for possible GBS. After decompensation with steroids, IVIG was started. On the 2nd day of IVIG, the patient showed improvement in her speech, swallowing and overall strength. The patient was discharged after 4 days of IVIG to another healthcare facility. The patient's neurological symptoms returned to 95 percent in 3 months. The patient had nasal congestion a few weeks prior to her acute weakness. The patient received RSV vaccine (Arexvy) 13 days, influenza vaccine 2 months, and Moderna COVID vaccine 6 weeks prior to onset of neurologic symptoms. GBS is reported in 1.5 case/million who received the GSK(Arexvy) RSV vaccine, and 5 cases/million in Pizer (Abrysvo) RSV vaccine. As per CDC, circumstances when vaccinations may be delayed or withheld included the followings: Delayed routine vaccination was suggested for patients who are within three months to two years after the onset of GBS. Future avoidance vs precaution when re-vaccination with the same vaccine is suggested when GBS occurs within six weeks following any specific immunization. The author suggested that vaccinations should be deferred when a precaution is present although a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk of an adverse reaction.; Reporter's Comments: A causal relationship cannot be fully excluded; however, given the latency period, the RSV vaccine represents a more plausible alternative explanation. The benefit-risk relationship of product is not affected by this report.
Cervical disc degeneration; Chronic kidney disease stage 3; Diabetes mellitus; Hypertension; Small bowel obstruction (Multiple SBO); Ulcerative colitis (UC s/p colectomy)
Medical History/Concurrent Conditions: Colectomy (UC s/p colectomy); J-pouch surgery (J pouch and ileoanal anastomosis)
Test Name: head/neck CTA; Test Result: Negative ; Test Name: CSF protein; Result Unstructured Data: markedly elevated; Test Name: CSF RBC; Result Unstructured Data: elevated; Test Name: CSF WBC; Result Unstructured Data: elevated; Test Name: EMG; Test Result: Negative ; Test Name: Spinal imaging; Result Unstructured Data: did not show clear abnormalities; Test Name: Brain MRI; Test Result: Negative