Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Nausea, Oral mucosal blistering, SARS-CoV-2 test
Clinical narrative: Blisters inside my mouth; The minute I got up I felt like I was falling; "I can't focus"; "My body went into convulsions and I throwed up"; Felt nauseated; "My body went into convulsions and I throwed up"; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE ("My body went into convulsions and I throwed up") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 041L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and COVID-19 (Was hospitalized for 21 days on ICU but not intubated.) in June 2020. Concurrent medical conditions included Asthma, Prediabetes, Obesity and Blood pressure high. Concomitant products included SERTRALINE from 2020 to an unknown date for Anxiety, MONTELUKAST from 2020 to an unknown date, METFORMIN from 2020 to an unknown date, LOSARTAN from 2020 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2020 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced SEIZURE ("My body went into convulsions and I throwed up") (seriousness criterion medically significant), BALANCE DISORDER (The minute I got up I felt like I was falling), DISTURBANCE IN ATTENTION ("I can't focus"), VOMITING ("My body went into convulsions and I throwed up") and NAUSEA (Felt nauseated). On 28-Oct-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters inside my mouth). At the time of the report, SEIZURE ("My body went into convulsions and I throwed up"), ORAL MUCOSAL BLISTERING (Blisters inside my mouth), BALANCE DISORDER (The minute I got up I felt like I was falling), DISTURBANCE IN ATTENTION ("I can't focus"), VOMITING ("My body went into convulsions and I throwed up") and NAUSEA (Felt nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: positive (Positive) positive.         No treatment medications were reported.  The patient stated that she just got sick with the first shot and took second one got sick again, and she meant out in the bed, can't wake up, lethargic. The patient felt the same thing for 3 days, since Monday noon until yesterday noon time too. The minute she got up she felt like she was falling. About a day ago, she got blisters inside her mouth.  Company Comment This case concerns a 60-year-old, female patient with previous relevant medical history of COVID-19, asthma, prediabetes, obesity, blood pressure high and anxiety, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the third dose. The medical history of COVID-19, asthma, prediabetes, obesity, blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-369052 (Patient Link).; Sender's Comments: This case concerns a 60-year-old, female patient with previous relevant medical history of COVID-19, asthma, prediabetes, obesity, blood pressure high and anxiety, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the third dose. The medical history of COVID-19, asthma, prediabetes, obesity, blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.