Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Back pain, Dizziness, Fall, Mobility decreased
Clinical narrative: Dizzy; fell out of bed could not get up; Shaking; Low grade fever; falling re-injured my back; fell out of bed could not get up; Back pain; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), TREMOR (Shaking) and PYREXIA (Low grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Q-Tip up nose) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985, High cholesterol since 2016 and Depression. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL, IRON and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), FALL (fell out of bed could not get up) (seriousness criterion hospitalization), MOBILITY DECREASED (fell out of bed could not get up) (seriousness criterion hospitalization), TREMOR (Shaking) (seriousness criterion hospitalization), PYREXIA (Low grade fever) (seriousness criterion hospitalization), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain). The patient was hospitalized from 21-Mar-2021 to 26-Mar-2021 due to DIZZINESS, FALL, MOBILITY DECREASED, PYREXIA and TREMOR. The patient was treated with Rehabilitation therapy for Fall; Rehabilitation therapy for Mobility decreased; Rehabilitation therapy for Back pain and Rehabilitation therapy for Pain in extremity. On 21-Mar-2021, DIZZINESS (Dizzy), TREMOR (Shaking) and PYREXIA (Low grade fever) had resolved. At the time of the report, FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain) had not resolved.            On 07April2020, the patient undergone Q-TIP up nose and tested positive for COVID-19 with no symptoms. Admitted to hospital from 21-mar-2021 to 26-mar-2021 and in rehabilitation till 24-apr-2021.  This case was linked to MOD-2021-060871 (Patient Link).  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 case was linked to MOD-2021-060871 (Patient Link).; 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.