Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Malaise, Pyrexia, Skin warm, Spinal fracture
Clinical narrative: passed out; compression fracture; chills were so cold; became very sick; She could not eat; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and COMPRESSION FRACTURE (compression fracture) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis (diagnosed 22 years ago).    On 10-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant), COMPRESSION FRACTURE (compression fracture) (seriousness criterion hospitalization), NASOPHARYNGITIS (chills were so cold), ILLNESS (became very sick), FEEDING DISORDER (She could not eat), PYREXIA (fever) and CHILLS (chills). The patient was hospitalized for 7 days due to COMPRESSION FRACTURE and LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), COMPRESSION FRACTURE (compression fracture), NASOPHARYNGITIS (chills were so cold), PYREXIA (fever) and CHILLS (chills) had not resolved and ILLNESS (became very sick) and FEEDING DISORDER (She could not eat) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any other vaccine at the same time as the DEC-2022 COVID-19 vaccine.  No concomitant medication were reported.  Patient did not measure the fever but was so hot that her body was soaked. The chills were so cold that patient did not get out of bed. Patient decided to go to the kitchen to make something to eat but passed out and broke her back. Patient was in the hospital Trauma Center for 1 week. Patient was diagnosed with Compression Fracture that still has not healed. Patient spent 2 weeks at a rehab.  No treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a 74-year-old female patient, with concurrent multiple sclerosis, who experienced the unexpected serious (hospitalization) events of Loss of consciousness (medically significant) and Compression fracture which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine received as third dose. It was reported that she passed out in the kitchen while cooking and broke her back. Events loss of consciousness and compression fracture were not resolved at the time of report. Underlying multiple sclerosis remains a confounding factor for the events. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to MOD-2023-721337 (Patient Link).