Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Somnolence, Syncope
Clinical narrative: seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decreased level of consciousness; worsened Depression; Difficulty breathing/issues with breathing; worsened Anxiety; Feeling ill; felt really tired; felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar) and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (2 surgeries on other leg). Concurrent medical conditions included Bipolar disorder, Gout (In one leg), Penicillin allergy (reaction- nausea), Drug allergy (Revatio (reaction- nausea)), Drug allergy (Vicodin (reaction- nausea)), Seasonal allergy (reaction- congestion), Anxiety (worse with COVID mask use) and Depression (worse with COVID mask use). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 19-Apr-2021 to an unknown date for Depression, INDOMETACIN (INDOCIN [INDOMETACIN]) from 07-Oct-2020 to an unknown date for Gout, NAPROXEN SODIUM (ALEVE) from 24-Sep-2019 to an unknown date for Pain.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), ILLNESS (Feeling ill) and FATIGUE (felt really tired). On 14-Jun-2021, the patient experienced ANXIETY (worsened Anxiety). On an unknown date, the patient experienced SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work) (seriousness criterion medically significant), BIPOLAR DISORDER (worsened Bipolar) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DEPRESSION (worsened Depression) and DYSPNOEA (Difficulty breathing/issues with breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and OLANZAPINE (ZYPREXA) (oral) ongoing from 07-Jul-2021 for Bipolar affective disorder aggravated, at a dose of 10 mg. At the time of the report, SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ANXIETY (worsened Anxiety), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (worsened Anxiety) to be possibly related. No further causality assessments were provided for SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired).    After getting the vaccine in the morning, the patient felt really tired. The patient went to the family doctor for a previously scheduled appointment regarding his condition. On the way there he couldn't keep the eyes open, and felt as if he didn't get enough sleep. The patient hadn't realized that he slept. The patient had assistance from his son because he felt like he could catch his train of thought. The patient told his O2 level was fine and was instructed to take Benadryl.  The HCP reported that anxiety, depression and bipolar might be psychological and wondered why these had gotten worse.  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. However, history of bipolar depression and anxiety may remain as risk factors.   This case was linked to MOD-2021-215030, MOD-2021-214836 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up contains New event , Medical history On 08-Jul-2021: Follow-up included: Medical history was updated, Patient weight, anatomical location of vaccine administered, Dose 1 details added On 14-Jul-2021: Case has been updated from non-serious to serious due to the addition of Serious events. New non-serious events also have been added. Patient's demographic details and reporter contact details were updated. Patient's medical history including allergies and current conditions, concomitant medications and treatment details were added.; 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. However, history of bipolar depression and anxiety may remain as risk factors.