Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Vaccination site pain, Vertigo
Clinical narrative: fainted,After she fainted was on the bathroom floor for 2 hours; sweats,then she was sweating profusely; hit her head on the wall,the fact that she fainted and hit her head was awful; severe dizziness; room was spinning and spinning and spinning; it was horrible,the most horrible experience of her life; could not get up of the floor,that night, she couldn't walk; still feels very weak; was freezing cold; extreme fatigue,not as weak as before but still very tired; fever; chills; headache "like I never had in my life",still has a little headache; left arm where she received the injection was sore, tender,(left arm tender)it still is,can move it but it hurts to move it.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted, After she fainted was on the bathroom floor for 2 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 091D2-1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced VACCINATION SITE PAIN (left arm where she received the injection was sore, tender,(left arm tender)it still is,can move it but it hurts to move it.). On 15-Aug-2021 at 3:00 AM, the patient experienced SYNCOPE (fainted,After she fainted was on the bathroom floor for 2 hours) (seriousness criterion medically significant), HYPERHIDROSIS (sweats,then she was sweating profusely), HEAD INJURY (hit her head on the wall,the fact that she fainted and hit her head was awful), DIZZINESS (severe dizziness), VERTIGO (room was spinning and spinning and spinning), FEELING ABNORMAL (it was horrible,the most horrible experience of her life), GAIT DISTURBANCE (could not get up of the floor,that night, she couldn't walk), ASTHENIA (still feels very weak), FEELING COLD (was freezing cold), FATIGUE (extreme fatigue,not as weak as before but still very tired), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache "like I never had in my life",still has a little headache). At the time of the report, SYNCOPE (fainted,After she fainted was on the bathroom floor for 2 hours), HYPERHIDROSIS (sweats,then she was sweating profusely), HEAD INJURY (hit her head on the wall,the fact that she fainted and hit her head was awful), DIZZINESS (severe dizziness), VERTIGO (room was spinning and spinning and spinning), FEELING ABNORMAL (it was horrible,the most horrible experience of her life), FEELING COLD (was freezing cold), PYREXIA (fever) and CHILLS (chills) outcome was unknown, GAIT DISTURBANCE (could not get up of the floor,that night, she couldn't walk) had resolved and ASTHENIA (still feels very weak), VACCINATION SITE PAIN (left arm where she received the injection was sore, tender,(left arm tender)it still is,can move it but it hurts to move it.), FATIGUE (extreme fatigue,not as weak as before but still very tired) and HEADACHE (headache "like I never had in my life",still has a little headache) had not resolved.         Concomitant medication included Singular (unspecified). No treatment was reported.  Company comment: 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.   This case was linked to MOD-2021-287649 (Patient Link).; 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.