Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Diarrhoea, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: Decreased level of consciousness; Gums are still sore; Felt very weak; Could not move her arms and legs; Felt like her eye balls were coming out of their sockets; Felt like her body was shutting down; Irregular heart beat/ palpitations; diarrhea; abdominal cramping; red/itchy eyes; Sneezing/Runny nose; Bronchospasm; Wheezing; Hoarsness; chest tightness; unusual taste; Nausea/vomiting; She felt really fatigued; Had very bad chills; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), PALPITATIONS (Irregular heart beat/ palpitations), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), EYE PRURITUS (red/itchy eyes), RHINORRHOEA (Sneezing/Runny nose), BRONCHOSPASM (Bronchospasm), WHEEZING (Wheezing), DYSPHONIA (Hoarsness), CHEST DISCOMFORT (chest tightness), TASTE DISORDER (unusual taste) and VOMITING (Nausea/vomiting). 16-May-2021, the patient experienced GINGIVAL PAIN (Gums are still sore), ASTHENIA (Felt very weak), MOBILITY DECREASED (Could not move her arms and legs), OCULAR DISCOMFORT (Felt like her eye balls were coming out of their sockets), MALAISE (Felt like her body was shutting down), FATIGUE (She felt really fatigued) and CHILLS (Had very bad chills). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), EYE PRURITUS (red/itchy eyes), RHINORRHOEA (Sneezing/Runny nose), BRONCHOSPASM (Bronchospasm), DYSPHONIA (Hoarsness), CHEST DISCOMFORT (chest tightness), TASTE DISORDER (unusual taste) and VOMITING (Nausea/vomiting) had resolved with sequelae, GINGIVAL PAIN (Gums are still sore) had not resolved and ASTHENIA (Felt very weak), MOBILITY DECREASED (Could not move her arms and legs), OCULAR DISCOMFORT (Felt like her eye balls were coming out of their sockets), MALAISE (Felt like her body was shutting down), PALPITATIONS (Irregular heart beat/ palpitations), WHEEZING (Wheezing), FATIGUE (She felt really fatigued) and CHILLS (Had very bad chills) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.  Company Comment: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced, serious unlisted event of Depressed level of consciousness among other non-serious events.The event occurred 2 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Significant Follow up received on 4-OCT-2021 and - New events ,event outcome updated from unknown to recovered with residual effect , and patient height updated.; Sender's Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced, serious unlisted event of Depressed level of consciousness among other non-serious events.The event occurred 2 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.