Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gout, Headache, Hypomania, Illness
Clinical narrative: Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weird"; Weakness; pain in ankle; Gout pain; Feeling ill; Feels like he almost wants to fall asleep; Vaccination site bruising; Fatigue; headache; arm sore(left arm), muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 053621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypoxia (Low oxygen), Mental disorder and Ankle operation. Concurrent medical conditions included Gout.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain) and FATIGUE (Fatigue). On 09-Jun-2021, the patient experienced ILLNESS (Feeling ill) and SOMNOLENCE (Feels like he almost wants to fall asleep). On 13-Jun-2021, the patient experienced GOUT (Gout pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PAIN (pain), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness) and ARTHRALGIA (pain in ankle). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout, at an unspecified dose and frequency and IBUPROFEN for Gout, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VACCINATION SITE BRUISING (Vaccination site bruising), PAIN (pain), GOUT (Gout pain), ILLNESS (Feeling ill), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), SOMNOLENCE (Feels like he almost wants to fall asleep), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain), ARTHRALGIA (pain in ankle) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications include unspecified mental health medications. Treatment information was not provided.   Company comment: 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-2021-215030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated new events- Mental issues, physical issues, Loss of Consciousness, Gout, Arthralgia, Hypomania and feeling abnormal. Updated patient history and treatment medications.; 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.