Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Impaired driving ability, Loss of personal independence in daily activities, Musculoskeletal disorder, Nervous system disorder
Clinical narrative: cannot write, nor be left alone; use cane to walk; cannot drive; Pneumonia; Pulmonary infarction; multiple ones traveled in both lungs; blood clot in her legs all the way from the tight to the ankles; tremor in the hand and legs, face shakes like parkinsonian disease; she is confused; neurological deficit; losing function in arms and legs; losing function in arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia), PULMONARY INFARCTION (Pulmonary infarction), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease), CONFUSIONAL STATE (she is confused), NERVOUS SYSTEM DISORDER (neurological deficit), the first episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), the second episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone), WALKING AID USER (use cane to walk) and IMPAIRED DRIVING ABILITY (cannot drive) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), PULMONARY INFARCTION (Pulmonary infarction) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ) (seriousness criteria hospitalization and medically significant), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles) (seriousness criteria hospitalization and medically significant), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease) (seriousness criterion hospitalization), CONFUSIONAL STATE (she is confused) (seriousness criterion hospitalization), NERVOUS SYSTEM DISORDER (neurological deficit) (seriousness criterion hospitalization), the first episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs) (seriousness criterion hospitalization), the second episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs) (seriousness criterion hospitalization), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone) (seriousness criteria hospitalization and disability), WALKING AID USER (use cane to walk) (seriousness criteria hospitalization and disability) and IMPAIRED DRIVING ABILITY (cannot drive) (seriousness criteria hospitalization and disability). The patient was treated with OXYGEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia), PULMONARY INFARCTION (Pulmonary infarction), PULMONARY THROMBOSIS (multiple ones traveled in both lungs ), THROMBOSIS (blood clot in her legs all the way from the tight to the ankles), TREMOR (tremor in the hand and legs, face shakes like parkinsonian disease), CONFUSIONAL STATE (she is confused), NERVOUS SYSTEM DISORDER (neurological deficit), the last episode of MUSCULOSKELETAL DISORDER (losing function in arms and legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot write, nor be left alone), WALKING AID USER (use cane to walk) and IMPAIRED DRIVING ABILITY (cannot drive) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment medications were provided.  It was reported that the nurse practitioner who used to handle about 40-50 patients per day, could not do that anymore and has been off work since 09 Apr 2021  Company comment: 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.; 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.