Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Limb injury, Muscle rigidity, Seizure, Unresponsive to stimuli
Clinical narrative: experienced seizures twice, was in complete darkness unable to see or hear; patient was unresponsive on the floor; started hysterically crying as she did not know what occurred; broke her toe and foot was all cut up/foot injury; looked totally blank and had totally unfocused eyes; became rigid; was throwing up while unconscious; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (experienced seizures twice, was in complete darkness unable to see or hear) and UNRESPONSIVE TO STIMULI (patient was unresponsive on the floor) in a 20-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.     The patient's past medical history included Ovarian cyst.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced SEIZURE (experienced seizures twice, was in complete darkness unable to see or hear) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (patient was unresponsive on the floor) (seriousness criterion medically significant), CRYING (started hysterically crying as she did not know what occurred), LIMB INJURY (broke her toe and foot was all cut up/foot injury), VISION BLURRED (looked totally blank and had totally unfocused eyes), MUSCLE RIGIDITY (became rigid) and VOMITING (was throwing up while unconscious). On 11-Sep-2021, SEIZURE (experienced seizures twice, was in complete darkness unable to see or hear), UNRESPONSIVE TO STIMULI (patient was unresponsive on the floor), CRYING (started hysterically crying as she did not know what occurred), LIMB INJURY (broke her toe and foot was all cut up/foot injury), VISION BLURRED (looked totally blank and had totally unfocused eyes), MUSCLE RIGIDITY (became rigid) and VOMITING (was throwing up while unconscious) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, White blood cell count: increased (High) Her white blood cells were a bit up.         The patient was on a low dose hormone birth control as concomitant medication for ovarian cysts which is gone now. No treatment information was reported. Patient experienced seizures twice on Saturday 11 Sep 2021 at around 2AM and 4:34AM. The caller stated that the patient "died before her eyes two times". The first time caller heard a crash, the patient was unresponsive on the floor. Once the caller got the patient up, patient started hysterically crying as she did not know what occurred. She broke her toe and her foot was all cut up. The patient went to the urgent care center where tests were done for 1.5 hours. Some testing were done such as EKG, neurological, bloodwork, and urine test. The second seizure occurred when patient was in the bedroom and sitting on the edge of the bed. Patient told her parents that it was happening again. She looked totally blank and had totally unfocused eyes became rigid and slipped down the bed. She was throwing up while unconscious and the caller and her husband was hitting her and yelling at her to wake up. The seizure lasted for 30 seconds for her to "switch back in". Patient stated it was complete darkness where she couldn't see and hear. She was shocked back in to life. Patient currently sleeps with in her mother's bed and is petrified to drive and go to sleep as she doesn't know when she might experience another seizure. Patient had no reactions upon first dose vaccination, not even a sorearm. She is not pregnant or breastfeeding. She is healthy. Company Comment: This case concerns a  20 year-old female patient, who experienced the  unexpected events of Seizure and Unresponsive to stimuli.  The events occurred one day after the second dose of mRNA-1273 vaccine.   The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The events of Seizure and Unresponsive to stimuli were assessed as Medically significant based on available information, including  reoccurrence of seizures twice in one day.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up information received on 13 Sep 2021, included reporters details, patient details, lab test, historical condition, suspect product start date, dose details, route of administration, unresponsive to stimuli, Uncontrollable crying, Toe injury, White blood cell count increased, Difficulty focusing eyes, Rigidity, fall, vomiting, Loss of personal independence in daily activities, shocked added as new events and narrative updated.; Sender's Comments: This case concerns a  20 year-old female patient, who experienced the  unexpected events of Seizure and Unresponsive to stimuli.  The events occurred one day after the second dose of mRNA-1273 vaccine.   The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The events of Seizure and Unresponsive to stimuli were assessed as Medically significant based on available information, including  reoccurrence of seizures twice in one day.