Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Seizure, Urinary incontinence, Vomiting
Clinical narrative: states she was completely soaked in urine; Patient took 0.5 ml of booster instead of 0.25ml; severe headache; vomit; seizure; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizure) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Oct-2022, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), HEADACHE (severe headache) and VOMITING (vomit). On an unknown date, the patient experienced URINARY INCONTINENCE (states she was completely soaked in urine) and INCORRECT DOSE ADMINISTERED (Patient took 0.5 ml of booster instead of 0.25ml). At the time of the report, SEIZURE (seizure), URINARY INCONTINENCE (states she was completely soaked in urine), HEADACHE (severe headache) and VOMITING (vomit) was resolving and INCORRECT DOSE ADMINISTERED (Patient took 0.5 ml of booster instead of 0.25ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The patient went into the kitchen to take ibuofren and woke up later at an unknown time on the floor. Denies hitting head, or any neurovascular complications in medical history.  Company comment: This is a spontaneous case reported by a health care professional. A 64-year-old female patient, with no reported medical history, experienced medically significant event of seizure (AESI) and non serious events of headache, vomiting and urinary incontinence 1 day after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Patient woke up with a severe headache, went into the kitchen to take ibuprofen and woke up later at an unknown time on the floor. Likely had a seizure, she was completely soaked in urine, and proceeded to vomit upon coming to. Patient denied hitting head, or any neurovascular complications in medical history. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a health care professional. A 64-year-old female patient, with no reported medical history, experienced medically significant event of seizure (AESI) and non serious events of headache, vomiting and urinary incontinence 1 day after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Patient woke up with a severe headache, went into the kitchen to take ibuprofen and woke up later at an unknown time on the floor. Likely had a seizure, she was completely soaked in urine, and proceeded to vomit upon coming to. Patient denied hitting head, or any neurovascular complications in medical history. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.