Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paralysis, Product dose omission issue, Vaccination site pain
Clinical narrative: I got really sick from the Moderna vaccine; The second shot was not received as the doctor told the patient not to receive it; I ended up in the ER with a severe kidney infection; could barely even talk; I was paralyzed for 4 days, , I needed my husband's help. I was in fetal position; I still have weakness in my legs, and pain in the arm were the injection was and everything that is mobile in the right side hurts; I couldn't stretch my legs; The pain was unbearable/verything that is mobile in the right side hurts; pain in the arm were the injection; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (I was paralyzed for 4 days, , I needed my husband's help. I was in fetal position) and KIDNEY INFECTION (I ended up in the ER with a severe kidney infection) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MEDROXYPROGESTERONE for an unknown indication.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced PARALYSIS (I was paralyzed for 4 days, , I needed my husband's help. I was in fetal position) (seriousness criterion medically significant), APHASIA (could barely even talk), MUSCULAR WEAKNESS (I still have weakness in my legs, and pain in the arm were the injection was and everything that is mobile in the right side hurts), LIMB DISCOMFORT (I couldn't stretch my legs), PAIN (The pain was unbearable/verything that is mobile in the right side hurts) and VACCINATION SITE PAIN (pain in the arm were the injection). On 15-Jul-2021, the patient experienced KIDNEY INFECTION (I ended up in the ER with a severe kidney infection) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (I got really sick from the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (The second shot was not received as the doctor told the patient not to receive it). On 31-Jul-2021, PARALYSIS (I was paralyzed for 4 days, I needed my husband's help. I was in fetal position), APHASIA (could barely even talk), LIMB DISCOMFORT (I couldn't stretch my legs) and PAIN (The pain was unbearable/verything that is mobile in the right side hurts) had resolved. At the time of the report, KIDNEY INFECTION (I ended up in the ER with a severe kidney infection) outcome was unknown, ILLNESS (I got really sick from the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (The second shot was not received as the doctor told the patient not to receive it) had resolved and MUSCULAR WEAKNESS (I still have weakness in my legs, and pain in the arm were the injection was and everything that is mobile in the right side hurts) and VACCINATION SITE PAIN (pain in the arm were the injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication not provided by reporter. Treatment information included antibiotics for kidney infection.  Company Comment  This report refers to a case of off label dosing frequency for mRNA-1273 with associated AEs reported as paralysis, kidney infection, speech disorder, muscular weakness, limb discomfort, vaccination site pain, illness and pain. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: This report refers to a case of off label dosing frequency for mRNA-1273 with associated AEs reported as paralysis, kidney infection, speech disorder, muscular weakness, limb discomfort, vaccination site pain, illness and pain. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.