Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Seizure, Syncope
Clinical narrative: fainted; lowering of his blood pressure; seizure; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (seizure) and SYNCOPE (fainted) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no known allergies.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine on 08-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine. Concurrent medical conditions included Seizure (Seizure disorder -6 seizures is his lifetime) and Prediabetes.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and HYPOTENSION (lowering of his blood pressure). At the time of the report, SEIZURE (seizure), SYNCOPE (fainted) and HYPOTENSION (lowering of his blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood pressure measurement: Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient received third dose on 06-Oc-2021, fourth dose on 04-May-2022 and fifth dose unknown probably October of 2022. No treatment medications were reported.  Company comment: This spontaneous case concerns a 72  year  old male patient, with medical history of seizure and glucose tolerance impaired, who experienced the unexpected, serious (medically significant) AESI seizure one day after receiving the second dose of Moderna COVID-19 Vaccine (mRNA  1273). The patient also experienced the unexpected serious (medically significant) event of syncope on un unknown date after the second dose with Moderna COVID-19 Vaccine (mRNA  1273). The report stated that the patient consulted to the emergency room because he had a seizure. The patient fainted and the medics found his blood pressure was extremely low. The reporter mentioned that the Covid vaccine contributed to the lowering of his blood pressure. No further clinical details were provided for medical reviewing. Patient´s medical history of seizure could be considered as a risk factor for seizure. Patient´s medical history of glucose tolerance impaired could be a confounding factor for syncope. The benefit-risk relationship of Moderna COVID-19 Vaccine (mRNA  1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735528, US-MODERNATX, INC.-MOD-2023-746556 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Oct-2023: Significant follow up information received medical history and events were added in the case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735528:Bivalent case US-MODERNATX, INC.-MOD-2023-746556:Same patient (7th dose)