Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: hard to wake him up; is very drowsy; At times patient is very active but suddenly becomes drowsy and that is not normal for him; took the patient's temperature, it reach 100°F, sometimes 99°; vomited but swallowed the vomit 2 or 3 times; patient suffered like reflux; doesn't want to eat; very tired; pain on the arm, reporter noticed it because patient slept with the arm elevated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm, reporter noticed it because patient slept with the arm elevated), SOMNOLENCE (hard to wake him up; is very drowsy; At times patient is very active but suddenly becomes drowsy and that is not normal for him), DECREASED APPETITE (doesn't want to eat), GASTROOESOPHAGEAL REFLUX DISEASE (patient suffered like reflux) and PYREXIA (took the patient's temperature, it reach 100°F, sometimes 99°) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Paralysis (brain paralysis). Concomitant products included LAMOTRIGINE for Epilepsy.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm, reporter noticed it because patient slept with the arm elevated). On 07-May-2021, the patient experienced DECREASED APPETITE (doesn't want to eat) and FATIGUE (very tired). On 09-May-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (patient suffered like reflux) and VOMITING (vomited but swallowed the vomit 2 or 3 times). On 10-May-2021, the patient experienced SOMNOLENCE (hard to wake him up; is very drowsy; At times patient is very active but suddenly becomes drowsy and that is not normal for him) and PYREXIA (took the patient's temperature, it reach 100°F, sometimes 99°). On 25-Apr-2021, PAIN IN EXTREMITY (pain on the arm, reporter noticed it because patient slept with the arm elevated) had resolved. On 09-May-2021, VOMITING (vomited but swallowed the vomit 2 or 3 times) outcome was unknown. At the time of the report, SOMNOLENCE (hard to wake him up; is very drowsy; At times patient is very active but suddenly becomes drowsy and that is not normal for him), DECREASED APPETITE (doesn't want to eat), GASTROOESOPHAGEAL REFLUX DISEASE (patient suffered like reflux), PYREXIA (took the patient's temperature, it reach 100°F, sometimes 99°) and FATIGUE (very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Pyrexia: 100.0 High, 99.0 (Borderline) normal for the patient and 98.0 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated her son, the patient, has brain paralysis and speaks very little. Reporter notices if something is wrong when patient gets angry. Reporter stated patient is breathing fine, and temperature never got above 101 degrees. Reporter stated the patient did not want to eat but was giving patient serum, milk, and juice.  Treatment information as not reported.  19-May-2021 patient has a scheduled doctor's appointment.   No treatment was reported.   This case was linked to MOD21-089413, MOD21-089414, INC.-MOD-2021-118867, US-MODERNATX, INC.-MOD-2021-118966 (E2B Linked Report).; Sender's Comments:  MOD21-089413:crosslinked MOD21-089414:crosslinked, INC.-MOD-2021-118966:Mother's case, INC.-MOD-2021-118867:Father's case