Sex: F
Vaccine: UNK
Symptoms: Aphasia, Dizziness, Hypoaesthesia, Impaired driving ability, Mental impairment
Clinical narrative: Mental impairment; Dizziness; Hypoaesthesia; Impaired driving ability; Throat tightness; This spontaneous case, initially received on 19-Dec-2024, was reported by a non-health professional and concerns an adult female patient.  Past medical history included Gastroparesis, Celiac, GERD, RA, Sciatica, Acid Reflux, High Blood Pressure, Iron Deficiency Anemia, Barrett's Esophagitis, Chronic Nausea, Dysphasia, Fibromyalgia, Gastritis, Hemiplegic Migraine, Hypertension, Neuropathy, Near Syncope. Drug history included Bactrim (Reaction: Allergy), Ceftin (Reaction: Allergy), Ceftriaxone Sodium (Reaction: Allergy), Cipro (Reaction: Allergy), Doxycycline (Reaction: Allergy), Macrobid (Reaction: Allergy), Sulfa Topicals/Sufa Drugs (Reaction: Allergy), Morphine (Reaction: Allergy), Effexor (Reaction: Allergy), Lortab (Reaction: Allergy), Prednisone (Reaction: Allergy), Tramadol (Reaction: Allergy), Trazodone (Reaction: Allergy), Prednisone (Reaction: Allergy). At the time of the event the patient had Urinary tract infection, Wheat Allergy, Seafood Allergy, Fruit Allergy, Meat Allergy, Egg Yolk Allergy, Food Allergy.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug:: On 03-Oct-2024, the patient received Afluria (TIV) for Drug use for unknown indication, Route of administration: Intramuscular, Anatomical site: Unknown, Lot number: No batch number available and will be requested upon follow up.  Non-company suspect drugs (captured as procedure in structured fields of medical history section due to limitations of WHO Drug Browser):  Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (SARS-CoV-2 Spike protein (Omicron variant JN.1), Indication: COVID-19 immunization, 0.5 ml, Route of administration: Intramuscular, Anatomical site: Unknown, Lot number: No batch number available.  Adverse reactions/events and outcomes: On 06-Oct-2024, the patient experienced Mental impairment (Medically Significant, outcome: Not recovered / Not resolved), Dizziness (outcome: Not recovered / Not resolved), Hypoaesthesia (outcome: Not recovered / Not resolved), Impaired driving ability (outcome: Not recovered / Not resolved), Throat tightness (outcome: Not recovered / Not resolved).  Relevant Lab tests included Emergency Care Examination (Result: The patient went to the ER at to be for an and have had these occur Since then, worsening as goes on, Test date: Unknwon).  Within 30 of the vaccines, the patient began to feel dizzy and numb in patient left Side. Started to her throat Close up and was hard to comprehend communicate. The doctor in the Clinic at the tine told her to sit in the waiting room which she did, for about an hour, because did not feel comfortable driving and felt like she was having an reaction.   Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the event Mental impairment as serious due to medically significant and other events as non-serious and did not provide the causality assessment for all the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Related for mental impairment, hypoesthesia, dizziness, impaired driving ability and throat tightness due to plausible temporal relationship. However, the medical history of hemiplegic migraine, hypertension, neuropathy and co-suspect Novavax COVID-19 Vaccine could have contributed to the events.