Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash, Syncope
Clinical narrative: Fainted on a tile floor; Bruised tailbone / Bruised back; Hurt right arm/ hurt arm and Hurt right shoulder; Hurt elbow; Hit head; Twisted neck; Dizzy; Rash; Muscle pain; Joint pain; Chills; Headache comes and goes; Slight fever; Very fatigue and Very tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted on a tile floor) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced SYNCOPE (Fainted on a tile floor) (seriousness criterion medically significant), CONTUSION (Bruised tailbone / Bruised back), LIMB INJURY (Hurt right arm/ hurt arm and Hurt right shoulder), JOINT INJURY (Hurt elbow), HEAD INJURY (Hit head), LIGAMENT SPRAIN (Twisted neck), DIZZINESS (Dizzy), RASH (Rash), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Headache comes and goes), PYREXIA (Slight fever), FATIGUE (Very fatigue and Very tired) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of 650 mg every eight hours. At the time of the report, SYNCOPE (Fainted on a tile floor) outcome was unknown and CONTUSION (Bruised tailbone / Bruised back), LIMB INJURY (Hurt right arm/ hurt arm and Hurt right shoulder), JOINT INJURY (Hurt elbow), HEAD INJURY (Hit head), LIGAMENT SPRAIN (Twisted neck), DIZZINESS (Dizzy), RASH (Rash), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Headache comes and goes), PYREXIA (Slight fever), FATIGUE (Very fatigue and Very tired) and NAUSEA (Nausea) had not resolved.            Patient stated that 15 hours after getting the booster shot, she fainted on a tile floor.  She did x-ray and scan for her head.  Treatment also included application of heat on tailbone, exercise for neck and general exercise.  Company comment: This spontaneous case concerns a 90-year-old female patient with no details on relevant medical history reported, who experienced the unexpected - according to a regulatory authority - serious (medically significant) event of Syncope after mRNA- 1273 Moderna vaccine. The event occurred approximately 15 hours after the booster dose of mRNA- 1273 vaccine. Very limited information is available regarding the circumstances leading to the event. Due to the fall, the patient experienced several contusions, twisted neck and hit her head. An X-ray and Head scan were performed, the results were not provided, however, only treatment with paracetamol was prescribed. It is unknown if further diagnostic work-up was requested to assess the aetiology of the event. Patient´s age remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 90-year-old female patient with no details on relevant medical history reported, who experienced the unexpected - according to a regulatory authority - serious (medically significant) event of Syncope after mRNA- 1273 Moderna vaccine. The event occurred approximately 15 hours after the booster dose of mRNA- 1273 vaccine. Very limited information is available regarding the circumstances leading to the event. Due to the fall, the patient experienced several contusions, twisted neck and hit her head. An X-ray and Head scan were performed, the results were not provided, however, only treatment with paracetamol was prescribed. It is unknown if other work-up was requested to assess the aetiology of the event. Patient´s age remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.