Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure measurement, Body temperature, Gait disturbance, Hypertension
Clinical narrative: blood pressure went over 200,; was having trouble moving around, stumbling; could speak/could not speaks, understood question but could not formulate answers had to be hospitalized for this; TEMPERATURE 103 F; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (blood pressure went over 200,), GAIT DISTURBANCE (was having trouble moving around, stumbling) and APHASIA (could speak/could not speaks, understood question but could not formulate answers had to be hospitalized for this) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies.  The patient never had COVID + test or diagnosis.  The patient had no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Concomitant products included FLUOXETINE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced HYPERTENSION (blood pressure went over 200,) (seriousness criterion hospitalization), GAIT DISTURBANCE (was having trouble moving around, stumbling) (seriousness criterion hospitalization) and APHASIA (could speak/could not speaks, understood question but could not formulate answers had to be hospitalized for this) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (blood pressure went over 200,), GAIT DISTURBANCE (was having trouble moving around, stumbling) and APHASIA (could speak/could not speaks, understood question but could not formulate answers had to be hospitalized for this) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2021, Blood pressure measurement: over 200 (High) over 200. On 24-Oct-2021, Body temperature: 103 (High) 103 degree Fahrenheit.         Patient concomitantly received other medications, that could not remember.   It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  On 22 Oct 2022, the patient received first booster dose and wanted guidance on whether take second booster or not as they had a severe reaction to their first booster.  The patient did not experience a similar event in the past.  The adverse events caused patient to get into emergency room and hospitalized for a day and half.  It was reported that symptoms disappeared.  No treatment drug was reported.  Company comment- This is a spontaneous case concerning an 80-year-old male patient with no medical history reported who experienced the unexpected and serious (hospitalized) events of hypertension, gait disturbance, pyrexia and aphasia 2 days after a booster dose of mRNA-1273 vaccine was administered. Patient´s age and gender remain as contributory risk factors for the events hypertension, gait disturbance, and aphasia. It was reported that his blood pressure went over 200, temperature was 103°F, and was having trouble moving around, stumbling; he also could not speak, he understood question but could not formulate answers. He had to be hospitalized for a day and half. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 80-year-old male patient with no medical history reported who experienced the unexpected and serious (hospitalized) events of hypertension, gait disturbance, pyrexia and aphasia 2 days after a booster dose of mRNA-1273 vaccine was administered. Patient´s age and gender remain as contributory risk factors for the events hypertension, gait disturbance, and aphasia. It was reported that his blood pressure went over 200, temperature was 103°F, and was having trouble moving around, stumbling; he also could not speak, he understood question but could not formulate answers. He had to be hospitalized for a day and half. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.