Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypersomnia, Hypokinesia
Clinical narrative: Caller mentioned lightheadedness; Chills; Tried to take third sweep/ Could not move shoulder, arm and hand or move the broom to sweep the third time; little fatigue; The next morning, slight temperature; pain in the arm; Slept for 12 straight hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 12 straight hours), HYPOKINESIA (Tried to take third sweep/ Could not move shoulder, arm and hand or move the broom to sweep the third time), PAIN IN EXTREMITY (pain in the arm), DIZZINESS (Caller mentioned lightheadedness) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (Lasted for 2 years) and Surgery (8 years ago got vertigo from the surgery). Concurrent medical conditions included Functional neurological symptom disorder (Basically, I had a functional neurological disorder (FND)).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in the arm). On 17-Feb-2021, the patient experienced FATIGUE (little fatigue) and PYREXIA (The next morning, slight temperature). On an unknown date, the patient experienced HYPERSOMNIA (Slept for 12 straight hours), HYPOKINESIA (Tried to take third sweep/ Could not move shoulder, arm and hand or move the broom to sweep the third time), DIZZINESS (Caller mentioned lightheadedness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in 2021 at an unspecified dose and frequency. On 17-Feb-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, HYPERSOMNIA (Slept for 12 straight hours), HYPOKINESIA (Tried to take third sweep/ Could not move shoulder, arm and hand or move the broom to sweep the third time), CHILLS (Chills), FATIGUE (little fatigue) and PYREXIA (The next morning, slight temperature) had resolved and DIZZINESS (Caller mentioned lightheadedness) outcome was unknown.            No concomitant medications were reported. Company comment:  This spontaneous case concerns 73 years old male patient with  medical history  of Vertigo, who experienced the unexpected AESI event of Hypersomnia and unexpected non serious event of Pain in extremity, Hypokinesia and Dizziness and expected non serious events of Pyrexia, Fatigue and chills. The event Pain in extremity occurred one day, pyrexia and Fatigue after 2 days and Hypersomnia ,Hypokinesia,Dizziness and chills occurred on unknown date   after the second dose of mRNA 1273 respectively .The outcome was reported  resolved  for Pain in extremity but unknown for other events.The elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 in not affected by this report   This case was linked to MOD-2021-418690 (Patient Link).; Sender's Comments: This spontaneous case concerns 73 years old male patient with  medical history  of Vertigo, who experienced the unexpected AESI event of Hypersomnia and unexpected non serious event of Pain in extremity, Hypokinesia and Dizziness and expected non serious events of Pyrexia, Fatigue and chills. The event Pain in extremity occurred one day, pyrexia and Fatigue after 2 days and Hypersomnia ,Hypokinesia,Dizziness and chills occurred on unknown date   after the second dose of mRNA 1273 respectively .The outcome was reported  resolved  for Pain in extremity but unknown for other events.The elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 in not affected by this report