Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | unknown | IM |
I had Guillain Barré with a very heavy paralysis; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. unknown) for COVID-19 prophylaxis. Concomitant products included Immunoglobulins and Steroids for an unknown indication. On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 milliliter. On 22-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Guillain-Barre syndrome. On 08-Jan-2023, GUILLAIN-BARRE SYNDROME (I had Guillain Barré with a very heavy paralysis) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: after many tests and differentiated diagnostics, I had Guillain Barré with a very heavy paralysis. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. After many tests and differentiated diagnostics, the patient had Guillain barre with a very heavy paralysis. The patient had full mobility now, after 2 years in physical rehab and therapies, the patient battles their consequences and sinkinesis in her face. No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Immunoglobulins; Steroids
Test Name: Investigations; Result Unstructured Data: After many tests and differentiated diagnostics, I had Guillain Barré with a very heavy paralysis.