Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Fall, Gait disturbance, Insomnia
Clinical narrative: Trouble standing; Able to walk into the kitchen awkwardly; It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body; Fell into a chair; Felt warm and had a fever of 100.3; Soreness in left arm; Hard to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (began new DMT, Tysabri, in June 2020, monthly infusion) and Anemia. Concomitant products included IRON for Anemia, NATALIZUMAB (TYSABRI) for Multiple sclerosis, VITAMIN D NOS and CALCIUM, ERGOCALCIFEROL (CALCIUM +D [CALCIUM;ERGOCALCIFEROL]) for an unknown indication.   On 26-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left arm). 23-Feb-2021, the patient experienced INSOMNIA (Hard to sleep). On 24-Feb-2021, the patient experienced FALL (Fell into a chair) and PYREXIA (Felt warm and had a fever of 100.3). On 24-Feb-2021 at 7:00 AM, the patient experienced PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body) (seriousness criterion medically significant), DYSSTASIA (Trouble standing) and GAIT DISTURBANCE (Able to walk into the kitchen awkwardly). At the time of the report, PARALYSIS (It felt like I was almost paralyzed/It was very difficult to control my legs and arms as if I had relapsed into losing the feeling in my whole body), PAIN IN EXTREMITY (Soreness in left arm), INSOMNIA (Hard to sleep), DYSSTASIA (Trouble standing), GAIT DISTURBANCE (Able to walk into the kitchen awkwardly), FALL (Fell into a chair) and PYREXIA (Felt warm and had a fever of 100.3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 100.3 (High) Increased.         Treatment information was not provided.  Company Comment: This case concerns a 55-year-old female with a serious unexpected event of paralysis, and nonserious unexpected pain in extremity, dysstasia, gait disturbance, fall, insomnia and expected pyrexia. Event onset 2 days after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-025381 (Patient Link).; Sender's Comments: This case concerns a 55-year-old female with a serious unexpected event of paralysis, and nonserious unexpected pain in extremity, dysstasia, gait disturbance, fall, insomnia and expected pyrexia. Event onset 2 days after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.