Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Cough, Decreased appetite
Clinical narrative: seizure; shortness of breath; mucus/was throwing up everything including mucus; She had reduced appetite; upset stomach; nausea; Vomiting; felt like she was going to die, like she got hit by a car; fever; coughing; unable to move; have no energy/body is very weak/She was weak; unable to go to work, and lost her job; arm was swollen; arm was itchy; 2nd dose after 38 days; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 0110214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacterial vaginosis. Previously administered products included for an unreported indication: FLU (Patient regularly takes the flu shot). Concurrent medical conditions included Diabetes, Asthma, Seizure, Anxiety and Arthritis. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), PROCATEROL HYDROCHLORIDE (PRO-AIR) and GLUCOSE for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), PRURITUS (arm was itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 38 days). On 09-Jul-2021, the patient experienced IMPAIRED WORK ABILITY (unable to go to work, and lost her job), MOVEMENT DISORDER (unable to move), ASTHENIA (have no energy/body is very weak/She was weak), COUGH (coughing), VACCINATION COMPLICATION (felt like she was going to die, like she got hit by a car) and PYREXIA (fever). On 10-Jul-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), SECRETION DISCHARGE (mucus/was throwing up everything including mucus), DECREASED APPETITE (She had reduced appetite), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and VOMITING (Vomiting). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and Physical therapy (breathing exercise) for Dyspnoea. On 08-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 38 days) had resolved. On 10-Jul-2021, SEIZURE (seizure), DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (arm was swollen), PRURITUS (arm was itchy) and PYREXIA (fever) had resolved. At the time of the report, IMPAIRED WORK ABILITY (unable to go to work, and lost her job), MOVEMENT DISORDER (unable to move), ASTHENIA (have no energy/body is very weak/She was weak), SECRETION DISCHARGE (mucus/was throwing up everything including mucus), COUGH (coughing), VACCINATION COMPLICATION (felt like she was going to die, like she got hit by a car), DECREASED APPETITE (She had reduced appetite), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, Body temperature: 101 (High) High.         The patient reported her A1C was at 9 for at least 3 months to date.  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. Additionally, this is also a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #027D21A). Further information has been requested.   This case was linked to MOD-2021-256558 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Case upgraded to serious; Patient medical history, lab data, concomitant and treatment medication, new events added, and narrative updated.; 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. Additionally, this is also a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #027D21A). Further information has been requested.