Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination complication, Viral titre increased, Vitamin D deficiency
Clinical narrative: Feel horrible; Fatigue like I've never had; cannot drive; viral count was active and very high.; vitamin D deficiency; fell asleep while driving; couldn't get out of bed/felt sick; pains; fever; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL TITRE INCREASED (viral count was active and very high.), IMPAIRED DRIVING ABILITY (cannot drive) and SOMNOLENCE (fell asleep while driving) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0392KKOA and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epstein-Barr virus infection. Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION COMPLICATION (couldn't get out of bed/felt sick), PAIN (pains), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). In April 2021, the patient experienced SOMNOLENCE (fell asleep while driving) (seriousness criterion medically significant). On 21-May-2021, the patient experienced VIRAL TITRE INCREASED (viral count was active and very high.) (seriousness criterion medically significant) and VITAMIN D DEFICIENCY (vitamin D deficiency). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (cannot drive) (seriousness criterion disability), FEELING ABNORMAL (Feel horrible) and FATIGUE (Fatigue like I've never had). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date at a dose of 1 dosage form and COLECALCIFEROL (VITAMIN D 3) ongoing since an unknown date for Vitamin D deficiency, at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION COMPLICATION (couldn't get out of bed/felt sick), PAIN (pains), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) had resolved. At the time of the report, VIRAL TITRE INCREASED (viral count was active and very high.) and IMPAIRED DRIVING ABILITY (cannot drive) had not resolved and SOMNOLENCE (fell asleep while driving), VITAMIN D DEFICIENCY (vitamin D deficiency), FEELING ABNORMAL (Feel horrible) and FATIGUE (Fatigue like I've never had) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood immunoglobulin M: normal (normal) Normal. On 21-May-2021, Epstein-Barr virus test: positive (Positive) Positive. On 21-May-2021, Full blood count: normal (normal) The result were ok.. On 21-May-2021, Metabolic function test: normal (normal) The result were ok.         Concomitant product use was not provided by the reporter. The patient took diet and had fluids for the events and checked her blood pressure, heart rate, and temperature every day. She discussed her symptoms and results with a neurologist, ENT (ear, nose, and throat physician), and her primary care physician. She is following up next with her ENT (ear nose and throat physician) on 27-Aug-2021. She is on Anti-viral medication and it was very expensive.   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-2021-235765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Added new event pain in extremity. Additional information was updated in narrative; 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.