Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Change of bowel habit, Fatigue, Feeling abnormal, Headache
Clinical narrative: She ran in and out of consciousness/she couldn't hold her tea; She now had high blood pressure; Palpitations; She said it felt like a steal rod was going through her body/ She felt like an imbecile and brain dead/she feels stupid/brain fog kicked in; She had phantom smells like smelling bad meat; Her bowels have all changed; Sleep patterns had changed; She also has blurry vision; Her lymph nodes are still swollen to this day 15 months later; Had a fever of 105 degrees F; Had a headache; She was exhausted and can hardly drive/ She had fatigue/ She was so tired; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She ran in and out of consciousness/she couldn't hold her tea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease and Allergy to vaccine (Allergies-Moderna COVID-19 vaccination). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, MULTIVITAMIN [VITAMINS NOS], VITAMIN B12 NOS, VITAMIN C [ASCORBIC ACID] and UBIDECARENONE (COQ-10) for an unknown indication.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She ran in and out of consciousness/she couldn't hold her tea) (seriousness criterion medically significant), HYPERTENSION (She now had high blood pressure), PALPITATIONS (Palpitations), FEELING ABNORMAL (She said it felt like a steal rod was going through her body/ She felt like an imbecile and brain dead/she feels stupid/brain fog kicked in), PAROSMIA (She had phantom smells like smelling bad meat), CHANGE OF BOWEL HABIT (Her bowels have all changed), SLEEP DISORDER (Sleep patterns had changed), VISION BLURRED (She also has blurry vision), LYMPHADENOPATHY (Her lymph nodes are still swollen to this day 15 months later), PYREXIA (Had a fever of 105 degrees F), HEADACHE (Had a headache) and FATIGUE (She was exhausted and can hardly drive/ She had fatigue/ She was so tired). The patient was treated with CARVEDILOL for Palpitations and Blood pressure high, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (She ran in and out of consciousness/she couldn't hold her tea), FEELING ABNORMAL (She said it felt like a steal rod was going through her body/ She felt like an imbecile and brain dead/she feels stupid/brain fog kicked in), PAROSMIA (She had phantom smells like smelling bad meat), CHANGE OF BOWEL HABIT (Her bowels have all changed), SLEEP DISORDER (Sleep patterns had changed), VISION BLURRED (She also has blurry vision), PYREXIA (Had a fever of 105 degrees F), HEADACHE (Had a headache) and FATIGUE (She was exhausted and can hardly drive/ She had fatigue/ She was so tired) outcome was unknown and HYPERTENSION (She now had high blood pressure), PALPITATIONS (Palpitations) and LYMPHADENOPATHY (Her lymph nodes are still swollen to this day 15 months later) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 degrees f (High) Fever of 105 degrees F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient got the Moderna vaccination on 13-Jan-2021 at the facility. She states she had a severe reaction and many different weird symptoms as well over the last 15 months. She ran in and out of consciousness, she couldn't hold her tea, had a headache and had a fever of 105 degrees F. She said it feels like a steal rod was going through her body. A couple weeks later she had phantom smells like smelling bad meat. Then brain fog kicked in.   Her lymph nodes were still swollen to this day 15 months later at the time of report. She was out of vacation days and sick days at work and her doctor has no medical guidance. Patient can't do anything. She was exhausted and can hardly drive. She said this was not COVID-19 this was the shot. It was presenting as long term COVID but she never had COVID-19.  She has tried vitamins and sleeping. She now has high blood pressure and palpitations so she takes carvedilol now. She has fatigue. She was only able to remember a handful of weird symptoms like GI issues stating her bowels have all changed and her sleep patterns have changed. She also has blurry vision. She feels like an imbecile and brain dead, she feels stupid, She was so tired and beyond frustrated. She states this has been a horrible and life changing journey.  Other treatment medication reported included unspecified vitamins.  Company comment: This case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of loss of consciousness an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Concomitant event of pyrexia could be a confounding factor. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of loss of consciousness an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Concomitant event of pyrezia could be a confounding factor. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.