Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Confusional state, Nausea, Seizure
Clinical narrative: nausea; very confused; seizure in her bed; Anaphylactic allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure in her bed), CONFUSIONAL STATE (very confused), NAUSEA (nausea) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced SEIZURE (seizure in her bed) (seriousness criteria hospitalization and medically significant) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) (seriousness criteria hospitalization and medically significant). On 06-Sep-2021, the patient experienced CONFUSIONAL STATE (very confused) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization). The patient was hospitalized from 05-Sep-2021 to 07-Sep-2021 due to ANAPHYLACTIC REACTION, CONFUSIONAL STATE, NAUSEA and SEIZURE. At the time of the report, SEIZURE (seizure in her bed), CONFUSIONAL STATE (very confused), NAUSEA (nausea) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On Sunday, 05-Sep-2021, at 7 PM, patient experienced a seizure in her bed. She was taken to ER. The patient woke up after 24 hours in confused state and gradually became aware of her surroundings She was treated with anti seizure medications and fluids. She was discharged 48 hours later with seizure medications.  Company Comment: This case concerns a 52-year-old, female patient with no relevant medical history , who experienced the expected event of Anaphylactic reaction, also experienced seizures, confusional state and nausea. The event occurred the next day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible.  The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received on 13-sep-2021 includes dose description, events, vaccine facility information.; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history , who experienced the expected event of Anaphylactic reaction, also experienced seizures, confusional state and nausea. The event occurred the next day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible.  The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.