Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pyrexia
Clinical narrative: voice sounds congested but not congested; lungs and stomach out of normal; no energy; lungs and stomach out of normal; so tired; Temp high again; chills only at night; passed out; huge mark on arm at injection site; nerve pain; couldn't sleep; legs could not be still; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INJECTION SITE DISCOLOURATION (huge mark on arm at injection site), NEURALGIA (nerve pain), INSOMNIA (couldn't sleep) and LIMB DISCOMFORT (legs could not be still). On 19-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPHONIA (voice sounds congested but not congested), LUNG DISORDER (lungs and stomach out of normal), ASTHENIA (no energy), ABDOMINAL DISCOMFORT (lungs and stomach out of normal), FATIGUE (so tired), PYREXIA (Temp high again) and CHILLS (chills only at night). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) had resolved, INJECTION SITE DISCOLOURATION (huge mark on arm at injection site) had not resolved and NEURALGIA (nerve pain), INSOMNIA (couldn't sleep), LIMB DISCOMFORT (legs could not be still), DYSPHONIA (voice sounds congested but not congested), LUNG DISORDER (lungs and stomach out of normal), ASTHENIA (no energy), ABDOMINAL DISCOMFORT (lungs and stomach out of normal), FATIGUE (so tired), PYREXIA (Temp high again) and CHILLS (chills only at night) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided.  Company comment: This case concerns a 59 year-old female who experienced the unexpected events of Loss of Consciousness with Injection site discolouration, Neuralgia, Insomnia, and Limb discomfort. The event of Injection site discolouration occurred one day after receiving the second dose of  Moderna COVID-19 Vaccine. The event of Loss of Consciousness occurred 2 days after the second dose.The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up contains no new information.; Sender's Comments: This case concerns a 59 year-old female who experienced the unexpected events of Loss of Consciousness with Injection site discolouration, Neuralgia, Insomnia, and Limb discomfort. The event of Injection site discolouration occurred one day after receiving the second dose of  Moderna COVID-19 Vaccine. The event of Loss of Consciousness occurred 2 days after the second dose.The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.