Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Generalised tonic-clonic seizure, Ocular hyperaemia, Pain in extremity, Pyrexia
Clinical narrative: Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and red coloration around his eyes/his eyes were red; difficulty breathing; sore arm; fatigue; he had a high fever just by touching him, he was extremely warm to the touch.; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included ADD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.). On 28-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized from 28-Apr-2021 to 28-Apr-2021 due to GENERALISED TONIC-CLONIC SEIZURE. On 28-Apr-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. At the time of the report, SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) No results were provided. On an unknown date, Chest X-ray: (Inconclusive) No results were provided. On an unknown date, Computerised tomogram: (Inconclusive) No results were provided. On an unknown date, Urine analysis normal: (Inconclusive) No results were provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Treatment included Advil for fever, Maxipime, Keppra for seizure prevention and normal saline.  Action taken with mRNA-1273 in response to the event was Not Applicable   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.   This case was linked to US-MODERNATX, INC.-MOD-2021-098517, MODERNATX, INC.-MOD-2021-097451 (E2B Linked Report).; 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. MODERNATX, INC.-MOD-2021-098517:Case for dose 1 MODERNATX, INC.-MOD-2021-097451:Cross linked case