Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Suicidal behaviour, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL BEHAVIOR (suicidal/ I took an entire bottle of Tylenol PM. I wanted to die but was scared it would hurt) and EMOTIONAL DISORDER (emotions became violently unable to control/ to the point of completely mentally, emotional unstable/ feel vaccine did something to brain/ chemical balance/ emotional state) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient did not receive any other vaccine 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient's past medical history included Victim of abuse (the dreams of my ex-abuser I escaped are prominent in my mind). Concomitant products included IBUPROFEN for an unknown indication. On 06-Sep-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced SUICIDAL BEHAVIOUR (suicidal/ I took an entire bottle of Tylenol PM. I wanted to die but was scared it would hurt) (seriousness criterion medically significant), EMOTIONAL DISORDER (emotions became violently unable to control/ to the point of completely mentally, emotional unstable/ feel vaccine did something to brain/ chemical balance/ emotional state) (seriousness criterion medically significant), MENTAL DISORDER (emotions became violently unable to control/ to the point of completely mentally, emotional unstable/feel vaccine did something to brain/ chemical balance/ emotional state), ILLNESS (fell sick and run down), VOMITING (throwing up), FEEDING DISORDER (unable to eat for days), FEELING ABNORMAL (just don't feel right I feel different) and CEREBRAL DISORDER (feel vaccine did something to brain/ chemical balance/ emotional state). At the time of the report, SUICIDAL BEHAVIOR (suicidal/ I took an entire bottle of Tylenol PM. I wanted to die but was scared it would hurt), EMOTIONAL DISORDER (emotions became violently unable to control/ to the point of completely mentally, emotional unstable/ feel vaccine did something to brain/ chemical balance/ emotional state), MENTAL DISORDER (emotions became violently unable to control/ to the point of completely mentally, emotional unstable/feel vaccine did something to brain/ chemical balance/ emotional state), ILLNESS (fell sick and run down), VOMITING (throwing up), FEEDING DISORDER (unable to eat for days), FEELING ABNORMAL (just don't feel right I feel different) and CEREBRAL DISORDER (feel vaccine did something to brain/ chemical balance/ emotional state) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company comment: This is a spontaneous case concerning a 42-year-old female patient with history of Victim of abuse, who experienced the serious (medically significant) unexpected event suicidal behavior and emotional disorder, starting the day after receiving the first dose of mRNA-1273. Patient reported that "emotions became violently unable to control/ to the point of completely mentally, emotional unstable, event suicidal" and "I took and entire bottle of Tylenol PM. I wanted to die but was scared it would hurt". Patient´s victim of abuse history remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. It was reported that, the patient's emotions become violent and was unable to control to the point of completely mentally, emotionally unstable event suicidal. The patient also felt sick and run down, throwing up everyday for no reason and was not able to eat for days. The patient was not feeling right and was feeling different. A few weeks prior to this report, the patient took an entire bottle of Tylenol PM and wanted to die. According to the patient vaccine did something to her brain/chemical balance/emotional state. The patient visited emergency room/department/urgent care. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Sender's Comments: Company comment: This is a spontaneous case concerning a 42-year-old female patient with history of Victim of abuse, who experienced the serious (medically significant) unexpected event suicidal behavior and emotional disorder, starting the day after receiving the first dose of mRNA-1273. Patient reported that "emotions became violently unable to control/ to the point of completely mentally, emotional unstable, event suicidal" and "I took and entire bottle of Tylenol PM. I wanted to die but was scared it would hurt". Patient´s victim of abuse history remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.