Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Cardiac function test, Chest injury, Contusion
Clinical narrative: Fainted; Left rib cage injured; Aches in the bones; Ill; Fell face first into the floor, fell on my hands; Bruised his hand; Face injured; Left hip and knee is injured; Nausea; Aches in the joints; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and CHEST INJURY (Left rib cage injured) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient spent 50 days in the hospital) from October 2020 to 04-Dec-2020.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CHEST INJURY (Left rib cage injured) (seriousness criterion medically significant), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints). At the time of the report, SYNCOPE (Fainted), CHEST INJURY (Left rib cage injured), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac function test: normal (normal) normal (heart was ok).         No relevant concomitant medications were provided.  On 22 Apr 2021, patient experienced aches in his joints and bones, he was becoming ill and had nausea which triggered emergency and needing to go to bathroom. He was heading to the bathroom, he fainted and fell face first into the floor. He injured his face, fell on his hands. He had bruised his hand. His left rib cage and left hip and knee was injured. He went to the Emergency Department where he was told his heart was ok, he was not delirious and consciousness was ok. He stated, it has now been a week and the bruising is still there and the stiches will be coming off tomorrow.   No treatment information was provided.  Action taken with mRNA in respect to the events was not applicable.  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. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.; 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. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.