Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Nausea, Tremor, Vomiting
Clinical narrative: I had to have help to get to and from the bathroom; tremors, severe tremors; threw up one time; nauseated; chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nauseated), GAIT DISTURBANCE (I had to have help to get to and from the bathroom), TREMOR (tremors, severe tremors) and VOMITING (threw up one time) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Flu. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 (Dose 1) on 13-Feb-2021, Moderna COVID-19 (Dose 2) on 13-Mar-2021, Moderna COVID-19 (Dose 3) on 08-Dec-2021, Moderna COVID-19 (Dose 4) on 12-Oct-2022 and Spikevax XBB.1.5 (Dose 5) on 24-Dec-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19, Moderna COVID-19, Moderna COVID-19, Moderna COVID-19 and Spikevax XBB.1.5. Concurrent medical conditions included Addison's disease. Concomitant products included Prednisone for Addison's disease.    On 06-Dec-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 06-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CHILLS (chills) (seriousness criterion disability). On 07-Dec-2024, the patient experienced NAUSEA (nauseated) (seriousness criterion disability) and VOMITING (threw up one time) (seriousness criterion disability). On 08-Dec-2024, the patient experienced GAIT DISTURBANCE (I had to have help to get to and from the bathroom) (seriousness criterion disability) and TREMOR (tremors, severe tremors) (seriousness criterion disability). In December 2024, CHILLS (chills), NAUSEA (nauseated), GAIT DISTURBANCE (I had to have help to get to and from the bathroom), TREMOR (tremors, severe tremors) and VOMITING (threw up one time) had resolved.            On the day of vaccination at evening patient experienced symptom of chills and patient went to bed. The second day, patient faced difficulty to weak up and patient experienced   nausea and patient was throwing up one time. Patient stated that those symptoms were not the most concerned for her because she gets those kinds of reactions sometimes after the flu. She clarified, that previously after she got the flu, and she experienced similar symptom. On Sunday (08DEC2024) when patient was got up, she required help to go bathroom and patient was unable to hold a glass of water to take a sip. She experienced severe tremors which patient never experienced before.   It was reported that after on Sunday (08DEC2024) patient took concomitant medication, at a higher dose, and followed by patient received reduced dose for concomitant medication throughout the week.   Due to patient current condition, patient used to take concomitant medication every day. Patient used to take concomitant medication every day 4 mg in the morning and a half a milligram at night, but she increased the concomitant medication dose after the symptom tremor to stop the symptom.  No treatment medications provided by the reporter.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.