Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Delirium, Dyspnoea, Erythema, Joint swelling
Clinical narrative: Delirious; Hurt to breath; Elbow and knuckles swelled up; Became red; Fever; Threw Up; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Drug allergy, Trigeminal neuralgia, Memory deficit (Issues with Memory.) and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and LEVOTHYROXINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), DYSPNOEA (Hurt to breath), JOINT SWELLING (Elbow and knuckles swelled up), ERYTHEMA (Became red), PYREXIA (Fever) and VOMITING (Threw Up). At the time of the report, DELIRIUM (Delirious), DYSPNOEA (Hurt to breath), JOINT SWELLING (Elbow and knuckles swelled up), ERYTHEMA (Became red), PYREXIA (Fever) and VOMITING (Threw Up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever. On an unknown date, Oxygen saturation: low (Low) Oxygen was low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details has been provided  Company comment -This case concerns a  59-year-old, female patient with relevant medical history of Hypothyroidism, Drug allergy, Trigeminal neuralgia, Memory deficit and Multiple sclerosis; and concomitant medications of Ocrelizumab, Gabapentin, Duloxetine and Levothyroxine; who experienced the unexpected events of Delirium, Dyspnea, Joint swelling and Erythema; and the expected events of Pyrexia and Vomiting. The events occurred on an unknown date after an unknown dose number of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about another dose was disclosed.  The patient's medical history of Hypothyroidism, Drug allergy, Trigeminal neuralgia, Memory deficit and Multiple sclerosis; and concomitant medications of Ocrelizumab, Gabapentin, Duloxetine and Levothyroxine remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up information was received include no new information.; Sender's Comments: This case concerns a  59-year-old, female patient with relevant medical history of Hypothyroidism, Drug allergy, Trigeminal neuralgia, Memory deficit and Multiple sclerosis; and concomitant medications of Ocrelizumab, Gabapentin, Duloxetine and Levothyroxine; who experienced the unexpected events of Delirium, Dyspnea, Joint swelling and Erythema; and the expected events of Pyrexia and Vomiting. The events occurred on an unknown date after an unknown dose number of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about another dose was disclosed.  The patient's medical history of Hypothyroidism, Drug allergy, Trigeminal neuralgia, Memory deficit and Multiple sclerosis; and concomitant medications of Ocrelizumab, Gabapentin, Duloxetine and Levothyroxine remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.