Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Hypertension; Gait disturbance; Dizziness; Nystagmus; Nausea; Weakness; Fatigue; Severe vertigo; Vomiting; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VERTIGO (Severe vertigo), ASTHENIA (Weakness), HYPERTENSION (Hypertension), GAIT DISTURBANCE (Gait disturbance) and DIZZINESS (Dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary stent placement. Concurrent medical conditions included Coronary artery disease (referred to as atherosclerotic heart disease '(ASHD) with two stents' in additional source from VAERS) and Hypercholesterolemia. Concomitant products included CLOPIDOGREL for Coronary stent user, PRAVASTATIN for Hypercholesterolemia, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Dec-2020 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VERTIGO (Severe vertigo) and VOMITING (Vomiting). On 07-Jan-2021, the patient experienced ASTHENIA (Weakness) and GAIT DISTURBANCE (Gait disturbance). 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), NAUSEA (Nausea) and FATIGUE (Fatigue). On an unknown date, the patient experienced HYPERTENSION (Hypertension). At the time of the report, VERTIGO (Severe vertigo), ASTHENIA (Weakness), GAIT DISTURBANCE (Gait disturbance), DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 149/80 mmHg Reported as Blood pressure was above usual level (149/88) in VAERS report.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VERTIGO (Severe vertigo) and VOMITING (Vomiting) to have an unknown relationship. No further causality assessments were provided for ASTHENIA (Weakness), HYPERTENSION (Hypertension), GAIT DISTURBANCE (Gait disturbance), DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), NAUSEA (Nausea) and FATIGUE (Fatigue).    Per VAERS report received on 23-Mar-2021 the patient was no longer experiencing vertigo however she endorsed feeling dizzy, fatigued, and continued weakness.  Per follow-up report received on 31-Mar-2021 from the original reporter (patient's husband, also a physician) the patient was fully recovered and experienced no untoward reactions to the second vaccine injection. No treatment information was provided. Other concomitant medications include Black Yeast for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Accepted VAERS ICSR as follow up. Follow-up included additional event terms (Dizzy; fatigued) as of March 2021 and event outcome confirmed as resolved for Vertigo and ongoing weakness within case narrative of the report. Batch/lot number of first dose provided. On 30-Mar-2021: Vaccine information provided for first and second dose, additional patient information provided, additional details for concomitant medications provided, event start date updated for vomiting and vertigo (previously reported as 07-Jan-2021); outcome of events provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.