Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Gait disturbance, Lymphadenopathy, Migraine
Clinical narrative: Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that the adverse events started immediately after the first shot.  Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered.  This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.