Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Hypersomnia, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains for a couple of days), PAIN IN EXTREMITY (pain in fingers,pain in muscles of arms, pain in muscles of legs), DYSPNOEA (breathing problems,he woke up like this and breathing gotten worse every day,very low air goes into the lungs, air gets in but only to the top of the lungs), HYPERSOMNIA (sleeping a lot) and GAIT DISTURBANCE (cannot walk to the bathroom that he gets tired) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Flu-like symptoms (A few months ago before the first dose).Concurrent medical conditions included HIV infection.Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ATOMOXETINE HYDROCHLORIDE (STRATTERA), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and TRAZODONE for an unknown indication.On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced PAIN (pains for a couple of days), PAIN IN EXTREMITY (pain in fingers,pain in muscles of arms, pain in muscles of legs) and MYALGIA (Aches for a couple of days). On 05-Dec-2021, the patient experienced DYSPNOEA (breathing problems,he woke up like this and breathing gotten worse every day,very low air goes into the lungs, air gets in but only to the top of the lungs). On an unknown date, the patient experienced HYPERSOMNIA (sleeping a lot), GAIT DISTURBANCE (cannot walk to the bathroom that he gets tired) and FATIGUE (more tired than usual). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 800 mg. At the time of the report, PAIN (pains for a couple of days), PAIN IN EXTREMITY (pain in fingers,pain in muscles of arms, pain in muscles of legs), DYSPNOEA (breathing problems,he woke up like this and breathing gotten worse every day,very low air goes into the lungs, air gets in but only to the top of the lungs), HYPERSOMNIA (sleeping a lot), GAIT DISTURBANCE (cannot walk to the bathroom that he gets tired), FATIGUE (more tired than usual) and MYALGIA (Aches for a couple of days) outcome was unknown. Other concomitant drug included clonathan. Company comment:This is a spontaneous case concerning a 54-year-old male patient with the past medical history of Flu like symptoms and concurrent medical condition including HIV infection, who experienced the non serious unexpected event of Pain, Pain in extremity, Dyspnoea, Hypersomnia, and Gait disturbance. On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine), with the events of Pain, Pain in extremity, and Myalgia occurring on the same day. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2021-406142 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with the past medical history of Flu like symptoms and concurrent medical condition including HIV infection, who experienced the non serious unexpected event of Pain, Pain in extremity, Dyspnoea, Hypersomnia, and Gait disturbance. On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine), with the events of Pain, Pain in extremity, and Myalgia occurring on the same day. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.