Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paralysis, Urinary incontinence, Vaccination site pain
Clinical narrative: Patient was paralyzed from the waist down temporarily.; Continues to experience weakness in his left arm shoulder deltoid muscle.; could not control his bladder; Sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Patient was paralyzed from the waist down temporarily.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 832L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hereditary spastic paraplegia (Has a long standing case of Neurological Disease.) since 2020.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 2:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PARALYSIS (Patient was paralyzed from the waist down temporarily.) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Sore left injection site arm.). 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Continues to experience weakness in his left arm shoulder deltoid muscle.) and URINARY INCONTINENCE (could not control his bladder). On 04-Mar-2021, PARALYSIS (Patient was paralyzed from the waist down temporarily.) had resolved. At the time of the report, MUSCULAR WEAKNESS (Continues to experience weakness in his left arm shoulder deltoid muscle.) had not resolved and URINARY INCONTINENCE (could not control his bladder) and VACCINATION SITE PAIN (Sore left injection site arm.) outcome was unknown.            Concomitant information was not provided.  It was reported that the patient was paralyzed from the waist down temporarily. The patient had no strength in his legs and could not control his bladder. The paralysis resolved after 18 hours.  Treatment information was not provided. Company comment: This case concerns a 73-year-old, female patient with medical history of hereditary spastic paraplegia, who experienced the unexpected event of paralysis which was considered as medically significant., along with other non serious events. The events occurred on the same day after the second dose of mRNA-1273. As reported, the patient was paralyzed from the waist down temporarily. The patient had no strength in his legs and could not control his bladder. The paralysis resolved after 18 hours. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The above mentioned concurrent condition of hereditary spastic paraplegia remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-400059 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with medical history of hereditary spastic paraplegia, who experienced the unexpected event of paralysis which was considered as medically significant., along with other non serious events. The events occurred on the same day after the second dose of mRNA-1273. As reported, the patient was paralyzed from the waist down temporarily. The patient had no strength in his legs and could not control his bladder. The paralysis resolved after 18 hours. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The above mentioned concurrent condition of hereditary spastic paraplegia remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.