Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, Condition aggravated, Depression suicidal, Fatigue
Clinical narrative: had severe suicidal depression within 1 month of booster dose; her bipolar disorder was stable until after her booster dose; over the last 45 days she has had extreme fatigue to the point of barely being able to get out of bed; her bipolar disorder was stable until after her booster dose; This spontaneous case was reported by a patient and describes the occurrence of BIPOLAR DISORDER (her bipolar disorder was stable until after her booster dose) and DEPRESSION SUICIDAL (had severe suicidal depression within 1 month of booster dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no history of COVID.  Concurrent medical conditions included Bipolar disorder since 2009.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced DEPRESSION SUICIDAL (had severe suicidal depression within 1 month of booster dose) (seriousness criterion medically significant). In 2022, the patient experienced BIPOLAR DISORDER (her bipolar disorder was stable until after her booster dose) (seriousness criterion medically significant), CONDITION AGGRAVATED (her bipolar disorder was stable until after her booster dose) and FATIGUE (over the last 45 days she has had extreme fatigue to the point of barely being able to get out of bed). At the time of the report, BIPOLAR DISORDER (her bipolar disorder was stable until after her booster dose), DEPRESSION SUICIDAL (had severe suicidal depression within 1 month of booster dose) and CONDITION AGGRAVATED (her bipolar disorder was stable until after her booster dose) outcome was unknown and FATIGUE (over the last 45 days she has had extreme fatigue to the point of barely being able to get out of bed) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient said that over the last 45 days she has had extreme fatigue to the point of barely being able to get out of bed. Patient stated that nothing had changed in her life except that she had the booster dose.  No treatment information was provided.  Company comment: This spontaneous case concerns a 73-year-old female patient with relevant medical history of bipolar disorder, who experienced the unexpected serious (medically significant) events of Bipolar disorder and Depression suicidal, on an unspecified date within the same month after receiving the 3rd dose of mRNA-1273 vaccine. The outcome was reported as unknown. Details of concomitant medications, clinical course, investigation reports and treatment were not provided. Medical history or bipolar disorder remains a confounder for the events. Elderly age could be a risk factor. One year prior to the 3rd dose, the patient has received the 2nd dose of mRNA-1273 vaccine, but details of 1st dose were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with relevant medical history of bipolar disorder, who experienced the unexpected serious (medically significant) events of Bipolar disorder and Depression suicidal, on an unspecified date within the same month after receiving the 3rd dose of mRNA-1273 vaccine. The outcome was reported as unknown. Details of concomitant medications, clinical course, investigation reports and treatment were not provided. Medical history or bipolar disorder remains a confounder for the events. Elderly age could be a risk factor. One year prior to the 3rd dose, the patient has received the 2nd dose of mRNA-1273 vaccine, but details of 1st dose were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.