Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures or seizure like activity; Chest congestion with productive cough; Chest pain; Elevated blood pressure; Generalized discomfort; Chest congestion with productive cough; Elevated pulse; Temperature 101.5; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizures or seizure like activity) in an 86-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (PERSONAL HISTORY OF COVID-19) since an unknown date. Previously administered products included for COVID-19 prophylaxis: Moderna (Lot #030H21B  Exp. 01/02/22) on 17-Dec-2021, Moderna (Lot #068H21A  Exp. 02/07/2) on 13-Jan-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Lot #AS7140C  Exp. 10/08/22) on 14-Sep-2022; for Product used for unknown indication: Pfizer (Lot #FM9992  Exp. 07/13/22) on 16-Jun-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna, Moderna and Pfizer. Concurrent medical conditions included Drug allergy (Cefuroxime), Shellfish allergy (Shell Fish), Hypertension (ESSENTIAL (PRIMARY) HYPERTENSION), Shortness of breath, Wheezing, Hyperlipidemia, Depression, Anemia (iron deficiency/Anemia), Pneumonia, Hypokalemia, Appetite stimulated, Weight loss, Type 2 diabetes mellitus (WITHOUT COMPLICATIONS), Dementia (UNSPECIFIED SEVERITY, WITHOUT BEHAVIORAL DISTURBANC), Psychotic, Anxiety, Chronic kidney disease stage 4, Chronic obstructive pulmonary disease and Localized edema. Concomitant products included MIRTAZAPINE (MIRTAZAPIN) for Appetite stimulated, DULOXETINE HCL for Depression, ATORVASTATIN CALCIUM for Hyperlipidemia, AMLODIPINE BESYLATE, CLONIDINE HCL, DOXAZOSIN MESYLATE and METOPROLOL TARTRATE for Hypertension, POTASSIUM CHLORIDE (KLOR-CON M20) for Hypokalemia, FERROUS SULFATE for Iron deficiency, ONDANSETRON for Nausea and Vomiting, IPRATROPIUM for Pneumonia, ALBUTEROL SULFATE for Shortness of breath and Wheezing, HYDRALAZINE HYDROCHLORIDE (HYDRALAZIN) for an unknown indication.    On 07-Nov-2023 at 9:50 AM, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Nov-2023 at 11:08 PM, the patient experienced CHEST DISCOMFORT (Chest congestion with productive cough), CHEST PAIN (Chest pain), HYPERTENSION (Elevated blood pressure), DISCOMFORT (Generalized discomfort), PRODUCTIVE COUGH (Chest congestion with productive cough), HEART RATE INCREASED (Elevated pulse) and PYREXIA (Temperature 101.5). On an unknown date, the patient experienced SEIZURE (seizures or seizure like activity) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures or seizure like activity) outcome was unknown and CHEST DISCOMFORT (Chest congestion with productive cough), CHEST PAIN (Chest pain), HYPERTENSION (Elevated blood pressure), DISCOMFORT (Generalized discomfort), PRODUCTIVE COUGH (Chest congestion with productive cough), HEART RATE INCREASED (Elevated pulse) and PYREXIA (Temperature 101.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated. On an unknown date, Body temperature: 101.5. On an unknown date, Heart rate: elevated and Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   This case referred to 7 out of 9 patients who just had chest pains, hypo or hypertension and seizures or seizure like activity.  It was reported that they had 9 patients who had AE after getting the Spikevax vaccine. The had common AE - chest pains, hypo or hypertension and seizures or seizure like activity.  No treatments medications were reported.  Company Comment: This is a spontaneous case concerning a 86-year-old, male patient with relevant medical history of Drug allergy, Shellfish allergy Hypertension, Shortness of breath, Wheezing, Hyperlipidemia, Type 2 diabetes mellitus, Chronic kidney disease stage 4, Chronic obstructive pulmonary disease and Localized edema, among others, who experienced the serious (due to medically significant) unexpected, AESI of Seizures, among other non-serious events. The event Seizure occurred on an unknown date after a dose of SPIKEVAX 2023-2024 vaccine, received as the fifth dose of COVID-19 vaccination schedule, and the rest of the events Chest discomfort, Chest pain, Hypertension, Discomfort, Productive cough, Heart rate increased and Pyrexia occurred on the same day after the vaccine administration. The patient had also received first dose: Moderna on 17-Dec-2021; second dose: Moderna on 13-Jan-2022; third dose: BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 14-Sep-2022, and fourth dose: Pfizer on 16-Jun-2022. It was reported that the patient presented elevated blood pressure, elevated pulse, temperature 101.5, generalized discomfort and chest congestion with productive cough. The X ray results were negative. Clinical course, additional supportive diagnostic procedures, and treatment were not provided. The outcome of the event Seizure was unknown and for the rest of the events is was reported as recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live significant follow-up received. LOT number updated. On 10-Nov-2023: Live follow-up received with significant information: historical vaccine details updated. On 10-Nov-2023: Live follow-up received that contains significant information: Patient details, lab data, concomitant drug and events updated. On 13-Nov-2023: Live follow-up information received has no new information. On 13-Nov-2023: Live Significant follow up added. Reporter was added. Patient age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749140:Master case