Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: could not lift arm; didn't sleep much; face was bruised on the left side; fever; shivers; lost consciousness and collapsed; cannot drive due to arm pain, cannot get dressed due to arm pain; swelling of the lymph nodes; This spontaneous case was reported by a dietician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness and collapsed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness and collapsed) (seriousness criterion medically significant), PAIN IN EXTREMITY (cannot drive due to arm pain, cannot get dressed due to arm pain) and LYMPHADENOPATHY (swelling of the lymph nodes). On 10-Feb-2021 at 9:00 PM, the patient experienced PYREXIA (fever) and CHILLS (shivers). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (could not lift arm), INSOMNIA (didn't sleep much) and CONTUSION (face was bruised on the left side). On 17-Feb-2021, LOSS OF CONSCIOUSNESS (lost consciousness and collapsed), PYREXIA (fever) and CHILLS (shivers) had resolved. At the time of the report, PAIN IN EXTREMITY (cannot drive due to arm pain, cannot get dressed due to arm pain) outcome was unknown and MUSCULOSKELETAL DISORDER (could not lift arm), INSOMNIA (didn't sleep much), CONTUSION (face was bruised on the left side) and LYMPHADENOPATHY (swelling of the lymph nodes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram head: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  On 10-Feb-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on her left arm (non-dominant, unknown route) 1 dosage form.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Serious event lost consciousness and collapsed and non-serious events (could not lift arm, didn't sleep much, face was bruised on the left side).; Sender's Comments: CC: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.