Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Feeling abnormal, Heavy menstrual bleeding, Illness, Magnetic resonance imaging
Clinical narrative: Sick for the two days; Had period the following week and was extremely emotional and had a heavy period; Felt awful the rest of the day; Extremely emotional; Seizure; Not feeling well; Twitching my hands.; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 019b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (VIENVA) from 15-Mar-2021 to an unknown date for Birth control, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) from 01-May-2015 to an unknown date and COLLAGEN from 15-Mar-2021 to an unknown date for an unknown indication.   On 19-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced MALAISE (Not feeling well) and MUSCLE TWITCHING (Twitching my hands.). On 06-Jun-2021 at 2:30 PM, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional). At the time of the report, SEIZURE (Seizure), ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), MALAISE (Not feeling well), MUSCLE TWITCHING (Twitching my hands.), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative.         Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow Up document was received and had significant information. Added Lab data. On 18-Jul-2021: Follow-up document was received and had significant information. Added vaccine facility, patient demographics, medical history, concomitant medications, event start date. Added new events like sick, heavy period, not feeling well, hand twitching, emotional.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time.