Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Heart rate, Heart rate increased, Mental status changes, Paraesthesia
Clinical narrative: terrified about the second dose; More than 35 days after the first dose without receiving the second dose; suicide thoughts; lost 88 pounds; heart rate was high; felt like something was swollen in her head; felt pins and needles on the skin; felt like something was swollen in her skin; spiraled out of control; pretty sure that she had bad anxiety; Patient had 99.4° to 99.6° F temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (suicide thoughts) in a 38-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.     The patient's past medical history included Splenectomy (Patient doesn't have a spleen) and Gallbladder removal (Patient doesn't have a Gallbladder). Concurrent medical conditions included Thyroid disorder (Patient has thyroid problems.), Underweight, Anxiety and Heart rate high (Patient has high heart rate and thinks it's from the anxiety.).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SUICIDAL IDEATION (suicide thoughts) (seriousness criterion medically significant), WEIGHT DECREASED (lost 88 pounds), HEART RATE INCREASED (heart rate was high), HEAD DISCOMFORT (felt like something was swollen in her head), PARAESTHESIA (felt pins and needles on the skin), SKIN DISCOMFORT (felt like something was swollen in her skin), MENTAL STATUS CHANGES (spiraled out of control), ANXIETY (pretty sure that she had bad anxiety), BODY TEMPERATURE INCREASED (Patient had 99.4° to 99.6° F temperature) and CHILLS (chills). On an unknown date, the patient experienced FEAR (terrified about the second dose) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). On 12-Jan-2021, CHILLS (chills) had resolved. At the time of the report, SUICIDAL IDEATION (suicide thoughts), WEIGHT DECREASED (lost 88 pounds), HEART RATE INCREASED (heart rate was high), HEAD DISCOMFORT (felt like something was swollen in her head), PARAESTHESIA (felt pins and needles on the skin), SKIN DISCOMFORT (felt like something was swollen in her skin), MENTAL STATUS CHANGES (spiraled out of control), ANXIETY (pretty sure that she had bad anxiety), BODY TEMPERATURE INCREASED (Patient had 99.4° to 99.6° F temperature) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved and FEAR (terrified about the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 to 99.6 (High) Patient had 99.4 degree to 99.6 degree F temperature. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified thyroid and anxiety medication.  The patient reported that after the first dose, she was "pretty sure that she had bad anxiety". As soon as she got out of the facility, someone told her that she would be dead by Friday and since then, she spiraled out of control, she had suicide thoughts and lost 88 pounds. She had 99.4 to 99.6 F temperature, her heart rate was high, she felt like something was swollen in her head and skin and felt pins and needles on the skin. She also had chills the first night. She stated that it took weeks until she was back to her normal self. She did not take any treatment for her symptoms. She did not consult a doctor for her symptoms.  The patient reported that she will go for the second dose the day after the report, and she was terrified about it.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of anxiety provides alternative etiology for the events. Company causality for Product dose omission issue is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of anxiety provides alternative etiology for the events. Company causality for Product dose omission issue is not applicable.