Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate
Clinical narrative: Pneumonia , fever , cough; She says that the fall caused a brain injury, I now have some brain damage.; fall; Bony tenderness; Back pain; high fevers; migraines; high blood pressure; grand mal seizure/seizures / My last seizure was Saturday night I neveronce/tongue you will see the missing spots; This spontaneous case was reported by a patient and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/seizures / My last seizure was Saturday night I neveronce/tongue you will see the missing spots), PNEUMONIA (Pneumonia , fever , cough) and BRAIN INJURY (She says that the fall caused a brain injury, I now have some brain damage.) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 056A22A and 002M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Type 1 Diabetes (Novalog, Victoza), Propranolol for anxiety as needed, no previous COVID-19 diagnosis Allergies: Amoxicillin/Penicillin, Codeine, and strawberries.  Concurrent medical conditions included Type 1 diabetes mellitus, Anxiety, Penicillin allergy (Amoxicillin/Penicillin allergy), Fruit allergy (strawberries), Drug allergy (Codeine) and Allergy to antibiotic. Concomitant products included PROPRANOLOL for Anxiety and Hypertension, INSULIN ASPART (NOVOLOG) and LIRAGLUTIDE (VICTOZA) for Type 1 diabetes mellitus.   On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced PYREXIA (high fevers), MIGRAINE (migraines) and HYPERTENSION (high blood pressure). In 2022, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/seizures / My last seizure was Saturday night I neveronce/tongue you will see the missing spots) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (Pneumonia , fever , cough) (seriousness criterion medically significant), BRAIN INJURY (She says that the fall caused a brain injury, I now have some brain damage.) (seriousness criterion medically significant), FALL (fall), BONE PAIN (Bony tenderness) and BACK PAIN (Back pain). The patient was treated with BENZONATATE (TESSALON PERLE) for Cough, at an unspecified dose and frequency; AZITHROMYCIN for Cough and Pneumonia, at an unspecified dose and frequency and OXYCODONE at an unspecified dose and frequency. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure/seizures / My last seizure was Saturday night I neveronce/tongue you will see the missing spots), PYREXIA (high fevers), MIGRAINE (migraines) and HYPERTENSION (high blood pressure) had not resolved and PNEUMONIA (Pneumonia , fever , cough), BRAIN INJURY (She says that the fall caused a brain injury, I now have some brain damage.), FALL (fall), BONE PAIN (Bony tenderness) and BACK PAIN (Back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose fluctuation: sugar did not rise above 140 and did not get lower than 110. On an unknown date, Blood pressure measurement: 94/58(location: left arm). patient position : sitting, Cuff size: regular). On an unknown date, Body mass index: 22.90 kilogram per square metre. On an unknown date, Body temperature: T-max was 103 degrees fahrenheit and 36.8 degree Celsius 98.2 degree Fahrenheit(thermal). On an unknown date, Computerised tomogram: Pneumonia. On an unknown date, Heart rate: heart rate increased and 99. On an unknown date, Oxygen saturation: 98 %. On an unknown date, Respiratory rate: 16.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient reported that the seizures continued might twice a week but it was not as bad until the day after when woke up in the hospital and big chunks of her tongue was missing and she could not talk as she was very confused and had a brain injury. The doctor and her husband informed her that she had a really bad seizure in which she was unresponsive for 7 minutes. She fell in her kitchen and she went straight back her body locked up as she was twitching and foaming from her mouth and when the ambulance got her, they gave her double of the medications which they usually give for seizures because she was biting down so hard on her tongue that pieces of her tongue was in her teeth. She then had some brain damage due to the seizures and the fall which she never had any of these problems until these vaccines. She stated that her side effects started after she received the 2nd dose of the Moderna COVID-19 vaccine on 28-APR-2022. 2 days after receiving the vaccine, she was seen at the hospital for increased heart rate, high fevers, and uncontrolled muscle spasms. She also had high blood pressure and really bad headaches during that time. She said that her muscle spasms were really bad on the right side. She said that after the second dose she experienced minor seizures which she did not had before. However, a day after she had an episode of a major seizure where she fell on the floor and was completely unconscious for some time. She was diagnosed as having a grand mal seizure. She said that it was really bad and she was foaming at the mouth, and biting down on her tongue so hard that she had pieces of her tongue in her teeth. She said that the fall caused a brain injury as well due to which she now had foggy memory and cannot even remember her wedding day. The patient's last menstrual period date was 3-Nov-2014.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live follow up contains significant information: Events added, lab tests added, treatment drugs added, narrative was updated. On 09-Jan-2023: Live Significant follow-up received contains no new information.  company comment-This spontaneous case concerns a 31 year old female patient with concurrent Type 1 diabetes mellitus, who experienced the unexpected serious (medically significant) events of Generalised tonic-clonic seizure (AESI), Brain injury and Pneumonia (exact onset date unknown), after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose about 28 days ago with the same vaccine. 2 days after receiving the second dose, she was seen at the hospital for increased heart rate, high fever, migraine and uncontrolled muscle spasms. She also had high blood pressure and bad headaches during this time. She started experiencing minor seizures which she did not have before. She had an episode of a major seizure where she fell on the floor and was completely unconscious for some time. She was diagnosed as having a grand mal seizure. The fall caused a brain injury due to which she now has foggy memory. On an unknown date, her blood pressure was 94/58 mm Hg; blood glucose showed fluctuations; CT scan showed pneumonia. She was treated with anti- epileptic medication and  propranolol. No information on relevant investigations with accurate timelines and treatment details was available in the report. The event Generalised tonic-clonic seizure had not resolved. The outcome of Brain injury and Pneumonia was unknown. Concurrent Type 1 diabetes mellitus could be a risk factor for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31 year old female patient with concurrent Type 1 diabetes mellitus, who experienced the unexpected serious (medically significant) events of Generalised tonic-clonic seizure (AESI), Brain injury and Pneumonia (exact onset date unknown), after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose about 28 days ago with the same vaccine. 2 days after receiving the second dose, she was seen at the hospital for increased heart rate, high fever, migraine and uncontrolled muscle spasms. She also had high blood pressure and bad headaches during this time. She started experiencing minor seizures which she did not have before. She had an episode of a major seizure where she fell on the floor and was completely unconscious for some time. She was diagnosed as having a grand mal seizure. The fall caused a brain injury due to which she now has foggy memory. On an unknown date, her blood pressure was 94/58 mm Hg; blood glucose showed fluctuations; CT scan showed pneumonia. She was treated with anti- epileptic medication and  propranolol. No information on relevant investigations with accurate timelines and treatment details was available in the report. The event Generalised tonic-clonic seizure had not resolved. The outcome of Brain injury and Pneumonia was unknown. Concurrent Type 1 diabetes mellitus could be a risk factor for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.