Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Suicidal ideation, Suicide attempt
Clinical narrative: Became suicidal; She got more severe and had the suicidal attempt; Severe PMDD, PMS symptoms got much worse, a week before her period, she has high anxiety; Brain fog; She was not able to run, both knees had inflammation; She was spotting; Stress; Dizzy; irritable; Angry; Temperature 102; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDE ATTEMPT (She got more severe and had the suicidal attempt), SUICIDAL IDEATION (Became suicidal) and PREMENSTRUAL DYSPHORIC DISORDER (Severe PMDD, PMS symptoms got much worse, a week before her period, she has high anxiety) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and LITHIUM for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced SUICIDE ATTEMPT (She got more severe and had the suicidal attempt) (seriousness criteria hospitalization and medically significant). On 06-Sep-2021, the patient experienced SUICIDAL IDEATION (Became suicidal) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PREMENSTRUAL DYSPHORIC DISORDER (Severe PMDD, PMS symptoms got much worse, a week before her period, she has high anxiety) (seriousness criterion medically significant), FEELING ABNORMAL (Brain fog), INFLAMMATION (She was not able to run, both knees had inflammation), INTERMENSTRUAL BLEEDING (She was spotting), STRESS (Stress), DIZZINESS (Dizzy), IRRITABILITY (irritable), ANGER (Angry), PYREXIA (Temperature 102) and MYALGIA (Body aches). The patient was hospitalized for 7 days due to SUICIDE ATTEMPT. At the time of the report, SUICIDE ATTEMPT (She got more severe and had the suicidal attempt), SUICIDAL IDEATION (Became suicidal), PREMENSTRUAL DYSPHORIC DISORDER (Severe PMDD, PMS symptoms got much worse, a week before her period, she has high anxiety), FEELING ABNORMAL (Brain fog), INFLAMMATION (She was not able to run, both knees had inflammation), INTERMENSTRUAL BLEEDING (She was spotting), STRESS (Stress), DIZZINESS (Dizzy), IRRITABILITY (irritable), ANGER (Angry), PYREXIA (Temperature 102) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) High.  Treatment product was not provided by the reporter.  Company Comment - This case concerns a 25 year-old female patient with no reported medical history, who experienced the unexpected serious events of Suicide attempt, Premenstrual dysphoric disorder, and Suicidal ideation.  The event of Premenstrual dysphoric disorder occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The event of Suicide attempt occurred approximately one month after the second dose, while the event of Suicidal ideation occurred approximately 6 months after the second dose. The seriousness criteria of Medically significant was maintained for Premenstrual dysphoric disorder based on medical judgement, persistent symptoms, and multiple treatments required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-326949 (Patient Link).; Sender's Comments: This case concerns a 25 year-old female patient with no reported medical history, who experienced the unexpected serious events of Suicide attempt, Premenstrual dysphoric disorder, and Suicidal ideation.  The event of Premenstrual dysphoric disorder occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The event of Suicide attempt occurred approximately one month after the second dose, while the event of Suicidal ideation occurred approximately 6 months after the second dose. The seriousness criteria of Medically significant was maintained for Premenstrual dysphoric disorder based on medical judgement, persistent symptoms, and multiple treatments required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.