Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Head injury, Headache, Limb injury
Clinical narrative: leg, forehead, shoulder, and neck injury; leg, forehead, shoulder, and neck injury; leg, forehead, shoulder, and neck injury; fell unconscious for 25 minutes in the bathroom; injection site 10CM up and down she cannot move hand.; She cannot move her right side.; severe dizzy; severe reaction with very high fever of 104F.; severe headache.; whole body aches,; injection site 10CM up and down she cannot move hand.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (leg, forehead, shoulder, and neck injury), HEAD INJURY (leg, forehead, shoulder, and neck injury), NECK INJURY (leg, forehead, shoulder, and neck injury) and LOSS OF CONSCIOUSNESS (fell unconscious for 25 minutes in the bathroom) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (fell unconscious for 25 minutes in the bathroom) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (injection site 10CM up and down she cannot move hand.), MOBILITY DECREASED (She cannot move her right side.), DIZZINESS (severe dizzy), PYREXIA (severe reaction with very high fever of 104F.), HEADACHE (severe headache.), MYALGIA (whole body aches,) and VACCINATION SITE SWELLING (injection site 10CM up and down she cannot move hand.). On an unknown date, the patient experienced LIMB INJURY (leg, forehead, shoulder, and neck injury) (seriousness criterion hospitalization), HEAD INJURY (leg, forehead, shoulder, and neck injury) (seriousness criterion hospitalization) and NECK INJURY (leg, forehead, shoulder, and neck injury) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL A) at an unspecified dose and frequency. At the time of the report, LIMB INJURY (leg, forehead, shoulder, and neck injury), HEAD INJURY (leg, forehead, shoulder, and neck injury), NECK INJURY (leg, forehead, shoulder, and neck injury), VACCINATION SITE MOVEMENT IMPAIRMENT (injection site 10CM up and down she cannot move hand.), MOBILITY DECREASED (She cannot move her right side.), DIZZINESS (severe dizzy), PYREXIA (severe reaction with very high fever of 104F.), HEADACHE (severe headache.), MYALGIA (whole body aches,) and VACCINATION SITE SWELLING (injection site 10CM up and down she cannot move hand.) outcome was unknown and LOSS OF CONSCIOUSNESS (fell unconscious for 25 minutes in the bathroom) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Body temperature: 104 (High) 104F.         Patient did not have vaccination card. Patient did not know when the first shot was done. Patient wanted Moderna to pay her medical bills.  Relevant concomitant medications were not reported.   Company Comment - This regulatory authority case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of limb injury, head injury, neck injury and loss of consciousness. The events occurred on the same day after a dose of mRNA-1273 vaccine, considered as the third dose of her COVID-19 vaccination schedule, and had resolved at the time of the report. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of limb injury, head injury, neck injury and loss of consciousness. The events occurred on the same day after a dose of mRNA-1273 vaccine, considered as the third dose of her COVID-19 vaccination schedule, and had resolved at the time of the report. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.