Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | 6024MF020 | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388489 | — |
Acute respiratory failure; Guillain-Barre syndrome; Acute toxic metabolic encephalopathy; Quadriplegia; Areflexia; Muscular weakness; This spontaneous case, initially received on 21-Feb-2025, was reported by a non health professional and concerns an elderly female patient. Drug history included cefaclor (Reaction: allergy), erithromycin (Reaction: allergy). At the time of the event the patient had hypothyroidism, osteoporosis, hypertension, hypercholesterolemia, cerebrovascular small vessel disease, sciatica, osteoarthritis. On an unknown date, the patient had clotting factor transfusion and endotracheal intubation. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 03-Dec-2024, the patient received Fluad (TIV) for Drug use for unknown indication, Dose regimen and anatomical location: not reported, Route of administration: Unknown, Lot number: 388489. Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunisation. Patient received 0.5 ml, intramuscular, anatomical location: not reported on 03-Dec-2024. Adverse reactions/events and outcomes: On 25-Dec-2024, the patient experienced Acute respiratory failure (Medically Significant, Hospitalized, outcome: Unknown), Acute toxic metabolic encephalopathy (Medically Significant, Hospitalized, outcome: Unknown) and Guillain-Barre syndrome (Medically Significant, Hospitalized, outcome: Unknown) Associated symptoms included, Quadriplegia, Muscular weakness, Areflexia. An elderly female with relevant past medical history of hypertension, hyperlipidemia and hypothyroidism presented to an OSH (outside hospital) on 26-Dec-2024 with complaint of significant lower extremity weakness. Patient was found to have AIDP (Acute inflammatory demyelinating polyneuropathy), acute respiratory failure (extubated 05-Jan-2025), and acute toxic metabolic encephalopathy, now sip plasmapheresis (completed on 15-Jan-2025) and cryoprecipitate (16-Jan-2025) now presenting with incomplete tetraplegia with LE (lower extremity) much more affected than UE (upper extremity). Admitted to for AIDP on 17-Jan-2025. AIDP -consistent with GBS, especially given elevated CSF protein, absent DTRs and recent influenza and COVID vaccines about 1 month ago -CSF studies to date reviewed: Protein 124.6, glucose 101 -Lactic acid 2.2 -WBC 1, RBC 1 -Gram stain no organisms, Cx NGTD -VDRL not detected -VZV, HSV, CMV, WNV, enterovirus PCR negative -KOH prep reveals no mycelia or yeast forms; ABF smear negative -Cytology revealed increased white cells with a few neutrophils, lymphocytes and many monocytes -Completed 5 sessions of plasmapheresis last on 15-Jan-2205. Relevant lab tests included: CSF CULTURE NEGATIVE (Result: Negative, Test Date: Unknown), CSF GLUCOSE INCREASED (Result: INCREASED, Test Date: Unknown), CSF LACTATE DECREASED (Result: DECREASED, Test Date: Unknown), CSF PROTEIN INCREASED (Result: INCREASED, Test Date: Unknown), CSF RED BLOOD CELL COUNT POSITIVE (Result: Positive, Test Date: Unknown), CSF WHITE BLOOD CELL COUNT NEGATIVE (Result: Negative, Test Date: Unknown), CYTOLOGY ABNORMAL (Result: ABNORMAL, Test Date: Unknown) (increased white cells with a few neutrophils, lymphocytes and many monocytes), CYTOMEGALO VIRUS TEST NEGATIVE(Result: Negative, Test Date: Unknown), ENTERO VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown), GRAM STAIN NEGATIVE (Result: Negative, Test Date: Unknown), HERPES SIMPLEX TEST NEGATIVE (Result: Negative, Test Date: Unknown), MYCOBACTERIUM TEST NEGATIVE (Result: Negative, Test Date: Unknown), POTASSIUM HYDROXIDE PREPARATION NEGATIVE (Result: Negative, Test Date: Unknown), TREPONEMA TEST NEGATIVE ( Result: Negative, Test Date: Unknown), VARJCELLA VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown) and WEST NILE VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown). At the time of reporting, the event outcome of Acute respiratory failure was Unknown, Areflexia was Unknown, CSF glucose increased was Unknown, CSF red blood cell count positive was Unknown, CSF lactate decreased was Unknown, Guillain-Barre syndrome was Unknown, Quadriplegia was Unknown, CSF protein increased was Unknown, Cytology abnormal was Unknown, Toxic encephalopathy was Unknown and Muscular weakness was Unknown. Fluad (TIV) action taken: Not Applicable Reporter's causality: The reporter did not provide causality assessment and all events considered as serious (Hospitalization and medically significant).; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. Related for Guillain-Barre syndrome due to pharmacological plausibility. Guillain-Barre syndrome and Toxic encephalopathy are assessed as contributing factors for acute respiratory failure. Of note, co-suspect Novavax vaccine is considered as confounder for the events. The case meets Level 4 (due to insufficient information) Brighton Collaboration diagnostic certainty for the event of Guillain-Barre syndrome.
Hypercholesterolemia; Hypertension; Hypothyroidism; Osteoarthritis; Osteoporosis; Sciatica; Small vessel disease of diabetes mellitus
Medical History/Concurrent Conditions: Clotting factor transfusion; Endotracheal intubation
Benicar; Synthroid; Cytomel; Ambien; Crestor; Vitamin d3; Flonase
Test Name: glucose; Result Unstructured Data: 101 Unit: unknown; Test Name: protein; Result Unstructured Data: 124.6 Unit: unknown; Test Name: rbc; Result Unstructured Data: 1 Unit: unknown; Test Name: wbc; Result Unstructured Data: 1