Age: 72.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contrast echocardiogram, Diplopia, Echocardiogram
Clinical narrative: Eyelid function disorder; Vision blurred; Couldn't focus with the two eyes together; IIIrd nerve paralysis; Third cranial nerve palsy; Husband has had to drive me everywhere I needed to go; Left eye started watering; Could not open the left eye; Definite double vision; On 27-OCT-2023, this serious, initial Regulatory Authority safety report from was received via Centers for Disease Control and Prevention via Vaccine Adverse Event Reporting System (VAERS ID: 2704572-1) and was received by Novavax on 04-DEC-2023. The original reporter type was unknown.  A 72-year-old female of an unspecified race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine unspecified dose on 20-OCT-2023.  Medical history included Allergy to vaccine with Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) on an unreported date.  Concomitant medications included glipizide, metformin, Olmesartan HCTZ (hydrochlorothiazide, olmesartan medoxomil) 20-45 (no units reported), and methenamine.  On 21-OCT-2023, 1 day after vaccination, the individual experienced vision blurred (PT: Vision blurred) (Serious: Hospitalization and Medically Significant), eyelid function disorder (PT: Eyelid function disorder) (Serious: Hospitalization and Medically Significant), and IIIrd nerve paralysis (PT: IIIrd nerve paralysis) (Serious: Hospitalization and Medically Significant). The individual had an office visit, emergency room visit, and was hospitalized on 21-OCT-2023 for 6 days and discharged on 26-OCT-2023. No laboratory data was provided.  At the time of reporting, the event outcomes of Vision blurred, Eyelid function disorder, and IIIrd nerve paralysis were not recovered/not resolved.  The CDC's adverse event description (narrative) was provided as follows: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.  On 13-DEC-2023, significant additional information was received by Novavax from a nurse via the contact center. The following information has been updated in the case:   The individual was a 72-year-old female who was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 6 of COVID-19 vaccine) in the left arm on 20-OCT-2023 at 11:50 am at a pharmacy.   Additional medical history included Type 2 diabetes mellitus, Hypertension, Reaction to food additive (MSG [monosodium glutamate]), and Drug hypersensitivity to Bactrim DS (sulfamethoxazole, trimethoprim). The individual was previously vaccinated with Moderna COVID-19 vaccine (elasomeran) dose 1 on 12-JAN-2021, dose 2 on 09-FEB-2021, dose 3 on 28-OCT-2021, dose 4 on 05-JUL-2022, and dose 5 on 07-JAN-2023. It was reported that most of the Moderna COVID-19 vaccine doses gave her a sore arm (Pain in extremity). The individual had no illnesses up to a month prior to vaccination, and never tested positive for COVID-19.   Additional concomitant medications included Norvasc (amlodipine besilate) 10 mg and fenofibrate 160 mg. The dosage information for the following concomitant medications were updated: Olmesartan HCTZ 80-25 mg, metformin 1000 mg twice daily, and glipizide 5 mg  On 20-OCT-2023, about 4 hours after vaccination, the individual's left eye started watering (PT: Lacrimation increased). On 21-OCT-2023, the next morning, the individual woke up and could not open her left eye (PT: Apraxia). On 24-OCT-2023, the individual visited an Ophthalmologist because her left eye was still not opening, who immediately sent the individual to the hospital. The date of hospitalization was updated to 24-OCT-2023. At the hospital, a CAT scan, CAT scan with contrast (Computerised tomogram), MRI (Magnetic resonance imaging), EKG (Electrocardiogram), a blood test (bubble test) to check for blood clots (Contrast echocardiogram), and all sorts of tests (Laboratory test) were performed. The individual reported she believed the results were normal. On 26-OCT-2023, the individual saw a neurologist, who diagnosed her with third cranial nerve palsy (PT: IIIrd nerve paralysis) (Serious: Hospitalization and Medically Significant), said it would take 6-8 weeks to go away, and recommended she follow-up with him. On 30-OCT-2023, the individual went to a neuro-ophthalmologist who looked at her eye and determined there was nothing to do for it. The individual believes she should have been put on prednisone. Since an unreported day in OCT-2023, for the past 8 weeks prior to reporting, the individual's husband had to drive her everywhere she needed to go (PT: Impaired driving ability). On 28-NOV-2023, the individual had acupuncture as treatment, because she was given no medication or treatment for the events. On 28-NOV-2023, at that point after the acupuncture, the individual was able to open her eye, but it did not stay open, and she couldn't focus with the 2 eyes together (PT: Vision blurred) (Serious: Hospitalization and Medically Significant), and had definite double vision (PT: Diplopia). On 12-DEC-2023, the individual had a second acupuncture treatment done, and she reported it was really helping. At the time of reporting, the individual was starting to be able to use her left eye, and definitely was able to open it, but she was still having a little trouble with focusing.  On 28-NOV-2023, the event outcome of Apraxia was recovered/resolved. At the time of reporting, the event outcome of Lacrimation increased was Unknown, and the event outcome of Impaired driving ability was not recovered/not resolved. The event outcomes of Eyelid function disorder, IIIrd nerve paralysis, Vision blurred, and Diplopia were recovering/resolving.   Discrepancies were identified in the source document. Follow-up information was received from the individual who received the vaccine, who clarified contradicting information provided in the initial regulatory authority report. Hospitalization dates, event start dates, and outcomes were updated as reported in the most recent information.; Sender's Comments: This 72 year-old female experienced: Eyelid function disorder, Vision blurred, IIIrd nerve paralysis, Impaired driving ability, Lacrimation increased, Apraxia and Diplopia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The events Eyelid function disorder, Vision blurred and IIIrd nerve paralysis were reported as serious. The events Impaired driving ability, Lacrimation increased, Apraxia and Diplopia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.