Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Suicidal ideation, Tinnitus, Tremor, Weight
Clinical narrative: horrible anxiety; depression; sleep; I felt like I was going to kill myself; Couldn't stop shaking; Couldn't stop crying/I was crying all day long, everyday; 3 weeks later it got much louder; I started feeling numbness & tingling in my left foot & leg, off & on.; I started feeling numbness & tingling in my left foot & leg, off & on.; I felt very tired; tinnitus in both ears, but left is worst; I've lost 55 lbs between March 2021-Dec 2021; I couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (horrible anxiety), DEPRESSION (depression) and SUICIDAL IDEATION (I felt like I was going to kill myself) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced TINNITUS (tinnitus in both ears, but left is worst) and FATIGUE (I felt very tired). In March 2021, the patient experienced ANXIETY (horrible anxiety) (seriousness criteria hospitalization, disability and medically significant), DEPRESSION (depression) (seriousness criteria hospitalization, disability and medically significant), SUICIDAL IDEATION (I felt like I was going to kill myself) (seriousness criterion medically significant), TREMOR (Couldn't stop shaking), CRYING (Couldn't stop crying/I was crying all day long, everyday), TINNITUS (3 weeks later it got much louder), PARAESTHESIA (I started feeling numbness & tingling in my left foot & leg, off & on.) and HYPOAESTHESIA (I started feeling numbness & tingling in my left foot & leg, off & on.). In 2021, the patient experienced DECREASED APPETITE (I couldn't eat) and ABNORMAL LOSS OF WEIGHT (I've lost 55 lbs between March 2021-Dec 2021). On an unknown date, the patient experienced SLEEP DISORDER (sleep). The patient was hospitalized on sometime in September 2021 due to ANXIETY and DEPRESSION. The patient was treated with CLONAZEPAM (KLONOPIN) ongoing since an unknown date for Sleeplessness, at an unspecified dose and frequency; NORTRIPTYLINE ongoing since an unknown date for Depression, at an unspecified dose and frequency; Manual therapy for Anxiety and Manual therapy for Depression. In 2021, ABNORMAL LOSS OF WEIGHT (I've lost 55 lbs between March 2021-Dec 2021) had resolved. At the time of the report, ANXIETY (horrible anxiety) and DEPRESSION (depression) had not resolved and SUICIDAL IDEATION (I felt like I was going to kill myself), DECREASED APPETITE (I couldn't eat), TINNITUS (tinnitus in both ears, but left is worst), TREMOR (Couldn't stop shaking), CRYING (Couldn't stop crying/I was crying all day long, everyday), TINNITUS (3 weeks later it got much louder), PARAESTHESIA (I started feeling numbness & tingling in my left foot & leg, off & on.), HYPOAESTHESIA (I started feeling numbness & tingling in my left foot & leg, off & on.), SLEEP DISORDER (sleep) and FATIGUE (I felt very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: result not reported Result not reported. In 2021, Magnetic resonance imaging: result not reported Result not reported. In 2021, Weight: lost 55 lbs lost 55 lbs between March 2021 - Dec 2021. In 2021, X-ray: result not reported Result not reported.         No concomitant medications were provided. On 17-Jan-2021, patient received first dose (Lot number, exp date was unknown, anatomical Location was left arm) of Moderna COVID-19 vaccine, she had no side effects. On 14-Feb-2021, she received second dose (Lot number, exp date and anatomical Location was unknown) of Moderna COVID-19 vaccine. On that day, she had tinnitus in both ears, but left was worst, she felt very tired. Later after 3 weeks it got much louder and it turned into horrible anxiety and depression at that time. She couldn't stop shaking and crying. She felt like she was going to kill herself. End of Mar-2021, she started feeling numbness and tingling in her left foot and leg, off & on. On Sep-2021, she was hospitalized on a psychiatric unit. She had lost 55 lbs between Mar-2021-Dec-2021. She could not eat, she was crying all day long, everyday. She was doing TMS therapy at the time of report, because the other medicines were not working as well. Consent was given for Safety to follow up with/contact caller & HCP. COMPANY COMMENT: This is a Spontaneous case concerning an 57-years-old female patient with clinical history of 1st dose of Moderna Covid-19 vaccine 1/17/21 without side effects who experienced the unexpected events of ANXIETY, DEPRESSION, SUICIDAL IDEATION, SLEEP DISORDER (treated with hospitalization on a psychiatric unit, medicated with Klonopin and Nortriptyline), TINNITUS, TREMOR, CRYING, TINNITUS (2nd episode), PARAESTHESIA, HYPOAESTHESIA, DECREASED APPETITE, ABNORMAL LOSS OF WEIGHT and other expected event beginning 1 days after 2nd dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME, disability and hospitalization; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an 57-years-old female patient with clinical history of 1st dose of Moderna Covid-19 vaccine 1/17/21 without side effects who experienced the unexpected events of ANXIETY, DEPRESSION, SUICIDAL IDEATION, SLEEP DISORDER (treated with hospitalization on a psychiatric unit, medicated with Klonopin and Nortriptyline), TINNITUS, TREMOR, CRYING, TINNITUS (2nd episode), PARAESTHESIA, HYPOAESTHESIA, DECREASED APPETITE, ABNORMAL LOSS OF WEIGHT and other expected event beginning 1 days after 2nd dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME, disability and hospitalization