Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Dizziness, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: Will not receive second dose; Hypersensitivity reaction; flu like symptoms; Cough; flushing; Decreased level of consciousness; Dizzy; Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing; Shortness of breath/had trouble breathing; Hoarseness; Unusual taste; Hand hurt for 10days; Felt like confusion; Weak; Tightness in chest; Strange feeling; Fever; Fatigue; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (Weak), CHEST DISCOMFORT (Tightness in chest), FEELING ABNORMAL (Strange feeling), CONFUSIONAL STATE (Felt like confusion), PAIN IN EXTREMITY (Hand hurt for 10days), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizzy), PALPITATIONS (Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing), DYSPNOEA (Shortness of breath/had trouble breathing), DYSPHONIA (Hoarseness), TASTE DISORDER (Unusual taste), HYPERSENSITIVITY (Hypersensitivity reaction), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Cough) and FLUSHING (flushing). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Will not receive second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Apr-2021, PAIN IN EXTREMITY (Hand hurt for 10days) had resolved. On 30-Apr-2021, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DIZZINESS (Dizzy), ASTHENIA (Weak), CHEST DISCOMFORT (Tightness in chest), FEELING ABNORMAL (Strange feeling), PALPITATIONS (Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing), CONFUSIONAL STATE (Felt like confusion), DYSPNOEA (Shortness of breath/had trouble breathing), DYSPHONIA (Hoarseness), TASTE DISORDER (Unusual taste), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Cough), FLUSHING (flushing), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had resolved with sequelae, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Will not receive second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included unspecified healthy supplements.  Company Comment: Based on the available information and based on the infectious nature of the condition, the events are assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up : patient demographics (ethnicity, height and weight) updated, added events of decreased level of consciousness, dyspnea, hoarseness, unusual taste, flu like symptoms, cough, flushing, updated event outcome of events On 31-Jul-2021: Live follow up : updated event outcome; Sender's Comments: Based on the available information and based on the infectious nature of the condition, the events are assessed as unlikely related to mRNA-1273.