Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Decreased appetite, Delirium, Dyspnoea
Clinical narrative: feels like had seizure; delirious; head swelled up like a pumpkin/face, neck, hand swelling; Bloated; migraine headache in half of head; injection site hot, hard, pink, swollen bigger than a deck of cards; brain fog; GI system feels like 100 bottles of hot sauce; GI system felt like 100 bottles of hot sauce; No appetite; shortness of breath; fast heartbeat; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site very red; nausea; fatigue; face, upper chest, and arms turned pinkish; fever; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (feels like had seizure) and DELIRIUM (delirious) in a 64-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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (feels like had seizure) (seriousness criterion medically significant), DELIRIUM (delirious) (seriousness criterion medically significant), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever). At the time of the report, SEIZURE (feels like had seizure), DELIRIUM (delirious), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not given.  Action taken was not applicable as patient completed both the doses.  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. However, Further information has been requested.; 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. However, Further information has been requested.