Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysstasia, Fatigue, Gait disturbance, Immobile
Clinical narrative: she is immobilized; My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down; difficulty in standing for just 1-2 min/could hardly get up; Can hardly walk; More than 35 days passed from the first dose; I'm in pain; Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (she is immobilized) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PENTOXIFYLLINE, TRAMADOL, RIVAROXABAN (XARELTO) and DIGOXIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced IMMOBILE (she is immobilized) (seriousness criterion medically significant), BALANCE DISORDER (My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down), DYSSTASIA (difficulty in standing for just 1-2 min/could hardly get up), GAIT DISTURBANCE (Can hardly walk), PRODUCT DOSE OMISSION ISSUE (More than 35 days passed from the first dose), PAIN (I'm in pain) and FATIGUE (Severe fatigue). On 29-Apr-2021, DYSSTASIA (difficulty in standing for just 1-2 min/could hardly get up) had resolved. At the time of the report, IMMOBILE (she is immobilized), BALANCE DISORDER (My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down), GAIT DISTURBANCE (Can hardly walk), PRODUCT DOSE OMISSION ISSUE (More than 35 days passed from the first dose), PAIN (I'm in pain) and FATIGUE (Severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Blood pressure medicine was also reported as a concomitant drug.  No treatment information was reported. No adverse event as Medical History was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 001C21A with associated AEs; Immobile, Balance disorder, Dysstasia, Gait disturbance, Pain and Fatigue.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant follow up received; batch no of drug, events updated with onset dates, resolved date to one event On 10-Jun-2021: Upon internal review on 08-Dec-2022 non-significant corrections performed to update "case received from field" to blank; 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. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 001C21A with associated AEs; Immobile, Balance disorder, Dysstasia, Gait disturbance, Pain and Fatigue.