Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: lost the ability to work; had to used a wheelchair; constantly feeling they may faint; tremors that extended over time and up their spine, to the back of their head; excessive hunger; very sudden, strong weakness; their lower extremities begun to have tremors; fatigue; weakness in the legs.; very odd pressure in the head; like feeling dizzy; feeling like having a cold; extreme thirst; dry mouth; slight body ache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feeling like having a cold), THIRST (extreme thirst), DRY MOUTH (dry mouth), HEAD DISCOMFORT (very odd pressure in the head) and DIZZINESS (like feeling dizzy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue (2 episodes of debilitating fatigue). Concurrent medical conditions included Hashimoto's disease (from 23 years and is been well controlled). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced NASOPHARYNGITIS (feeling like having a cold), THIRST (extreme thirst), DRY MOUTH (dry mouth) and MYALGIA (slight body ache). In April 2021, the patient experienced HEAD DISCOMFORT (very odd pressure in the head) and DIZZINESS (like feeling dizzy). On 25-Apr-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs.   ) and FATIGUE (fatigue). On 27-Apr-2021, the patient experienced ASTHENIA (very sudden, strong weakness), TREMOR (their lower extremities begun to have tremors), PRESYNCOPE (constantly feeling they may faint), HEAD TITUBATION (tremors that extended over time and up their spine, to the back of their head   ) and HUNGER (excessive hunger   ). On 29-Apr-2021, the patient experienced WHEELCHAIR USER (had to used a wheelchair). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (lost the ability to work ). In April 2021, HEAD DISCOMFORT (very odd pressure in the head) and DIZZINESS (like feeling dizzy) had resolved. On 27-Apr-2021, MUSCULAR WEAKNESS (weakness in the legs.   ) and FATIGUE (fatigue) had resolved. At the time of the report, NASOPHARYNGITIS (feeling like having a cold), THIRST (extreme thirst), DRY MOUTH (dry mouth) and MYALGIA (slight body ache) had resolved and ASTHENIA (very sudden, strong weakness), TREMOR (their lower extremities begun to have tremors), WHEELCHAIR USER (had to used a wheelchair), PRESYNCOPE (constantly feeling they may faint), HEAD TITUBATION (tremors that extended over time and up their spine, to the back of their head   ), HUNGER (excessive hunger   ) and IMPAIRED WORK ABILITY (lost the ability to work ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Thyroid function test: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 25-Apr-2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) . No treatment information was provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality for all events except thyroid function test abnormal s assessed as possibly related, although confounded with patient's Hashimoto's disease and history of fatigue. The event of thyroid function test abnormal  is assessed as unlikely related since it is confounded with patient's Hashimoto's disease.   This case was linked to MOD-2021-309978 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality for all events except thyroid function test abnormal s assessed as possibly related, although confounded with patient's Hashimoto's disease and history of fatigue. The event of thyroid function test abnormal  is assessed as unlikely related since it is confounded with patient's Hashimoto's disease.