Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Impaired work ability, Insomnia, Lethargy
Clinical narrative: Unable to concentrate; caused me to miss a day of work; massive lethargy and fatigue; feels like having a bladder infection because has to go to bathroom all the time/feeling of needing to urinate constantly; massive lethargy and fatigue; massive shaking; teeth chattering; really rough night; feels like having a bladder infection because has to go to bathroom all the time; blocking around sleep; sore back and hips; sore back, knees and hips/intense pain in hips; temperature was 100.1°- 99.5°F/woke to 101.5 fever; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (really rough night), CYSTITIS (feels like having a bladder infection because has to go to bathroom all the time), INSOMNIA (blocking around sleep), BACK PAIN (sore back and hips) and MICTURITION URGENCY (feels like having a bladder infection because has to go to bathroom all the time/feeling of needing to urinate constantly) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], BIOFLAVONOIDS NOS, RESVERATROL, VITIS VINIFERA SEED (GRAPESEED EXTRACT [BIOFLAVONOIDS NOS;RESVERATROL;VITIS VINIFERA SEED]), SAMBUCUS NIGRA (ELDERBERRY EXTRACT), CURCUMIN, NICOTINAMIDE and MORINGA OLEIFERA (MORINGA [MORINGA OLEIFERA]) for an unknown indication, WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT).   On 16-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INSOMNIA (blocking around sleep) and PYREXIA (temperature was 100.1°- 99.5°F/woke to 101.5 fever). 13-Apr-2021, the patient experienced BACK PAIN (sore back and hips) and ARTHRALGIA (sore back, knees and hips/intense pain in hips). On 14-Apr-2021, the patient experienced INSOMNIA (really rough night). 14-Apr-2021, the patient experienced CYSTITIS (feels like having a bladder infection because has to go to bathroom all the time) and CHILLS (teeth chattering). 14-Apr-2021, the patient experienced TREMOR (massive shaking). On an unknown date, the patient experienced MICTURITION URGENCY (feels like having a bladder infection because has to go to bathroom all the time/feeling of needing to urinate constantly), DISTURBANCE IN ATTENTION (Unable to concentrate), IMPAIRED WORK ABILITY (caused me to miss a day of work), LETHARGY (massive lethargy and fatigue) and FATIGUE (massive lethargy and fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 14-Apr-2021 for Adverse event, at a dose of 1 dosage form. On 15-Apr-2021, CYSTITIS (feels like having a bladder infection because has to go to bathroom all the time) had resolved. At the time of the report, INSOMNIA (really rough night), INSOMNIA (blocking around sleep), MICTURITION URGENCY (feels like having a bladder infection because has to go to bathroom all the time/feeling of needing to urinate constantly), DISTURBANCE IN ATTENTION (Unable to concentrate), IMPAIRED WORK ABILITY (caused me to miss a day of work), LETHARGY (massive lethargy and fatigue), FATIGUE (massive lethargy and fatigue) and PYREXIA (temperature was 100.1°- 99.5°F/woke to 101.5 fever) outcome was unknown and BACK PAIN (sore back and hips), TREMOR (massive shaking), CHILLS (teeth chattering) and ARTHRALGIA (sore back, knees and hips/intense pain in hips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 99.5-100.1 (abnormal) Body temperature ranging from 99.5 - 100.1°F..         No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow-up ADR form received and contained information regarding concomitant medications, additional events/information as well as treatment.