Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I believe i'm having a stroke/ suffered a CVA; elevated BP; seizures or seizure like activity; chest pains; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (I believe i'm having a stroke/ suffered a CVA), HYPERTENSION (elevated BP) and SEIZURE (seizures or seizure like activity) in an 88-year-old female 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.     Patient had no known drug allergies.  The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: Moderna on 17-Mar-2021, Moderna on 14-Apr-2021 and Moderna Bivalent (Lot #AS7185B Exp. 06/22/23) on 01-Jun-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna Bivalent. Concurrent medical conditions included Tricuspid insufficiency (NONRHEUMATIC TRICUSPID (VALVE) INSUFFICIENCY), Hypoosmolar hyponatremia (HYPO-OSMOLALITY AND HYPONATREMIA), Cachexia, Unspecified protein-calorie malnutrition, Essential hypertension (ESSENTIAL (PRIMARY) HYPERTENSION), Hyperlipidemia (HYPERLIPIDEMIA, UNSPECIFIED), Anemia vitamin B12 deficiency, Vitamin deficiency NOS, Chronic kidney disease stage 2 (Mild), Generalized muscle weakness, Oropharyngeal dysphagia, Unsteadiness (UNSTEADINESS ON FEET), Neuromuscular disorder NOS (NEUROMUSCULAR DYSFUNCTION OF BLADDER, UNSPECIFIED), Chronic respiratory failure (CHRONIC RESPIRATORY FAILURE WITH HYPOXIA), Takotsubo syndrome, Osteoarthritis and Pain. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Hypertension, MELOXICAM for Osteoarthritis, ACETAMINOPHEN and PARACETAMOL (TYLENOL) for Pain, LACTOBACILLUS ACIDOPHILUS (BACID) for an unknown indication.    On 08-Nov-2023 at 11:31 AM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Nov-2023 at 11:23 AM, the patient experienced CEREBROVASCULAR ACCIDENT (I believe i'm having a stroke/ suffered a CVA) (seriousness criteria hospitalization, medically significant and life threatening) and HYPERTENSION (elevated BP) (seriousness criteria hospitalization and life threatening). On an unknown date, the patient experienced SEIZURE (seizures or seizure like activity) (seriousness criterion medically significant) and CHEST PAIN (chest pains). At the time of the report, CEREBROVASCULAR ACCIDENT (I believe i'm having a stroke/ suffered a CVA) and HYPERTENSION (elevated BP) had not resolved and SEIZURE (seizures or seizure like activity) and CHEST PAIN (chest pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Blood pressure measurement: 224/140 (elevated) and 252/150. In November 2023, Heart rate: 115 and 118.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Age reported as 88 years 6 months. Concomitant medications included Multivitamin-Minerals Oral Tablet (Multiple Vitamins w/ Minerals) 1 tablet by mouth one time a day for nutritional support. Patient presented with elevated BP and altered mental status, approached nurse saying she believed she is having a stroke, she was sent to emergency room. Patient was unable to lift right arm, stated as her legs were numb, unable to feel pressure when put on right foot. When asked to smile, patient was unable to smile.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140, US-MODERNATX, INC.-MOD-2023-749732 (Linked Report).  Company Comment: This is a spontaneous case concerning a 88-year-old female patient with relevant medical history of Tricuspid insufficiency, Cachexia, Unspecified protein-calorie malnutrition, Essential hypertension, Hyperlipidemia, Anemia vitamin B12 deficiency, Chronic kidney disease stage 2, Unsteadiness, Chronic respiratory failure and Takotsubo syndrome, among others, who experienced the serious (due to medically significant, life-threatening and hospitalization) unexpected AESI of Cerebrovascular accident, the serious (due to life-threatening and hospitalization) unexpected adverse event of Hypertension, and the serious (due to medically significant) unexpected AESI of Seizures and the non-serious unexpected event of Chest pain. The events Cerebrovascular accident and Hypertension occurred approximately the following day after the 4th dose of SPIKEVAX 2023-2024 received as the fourth dose of COVID-19 vaccination schedule, and the event Seizure occurred on an unknown date, after the vaccine administration. The patient had received the first dose: Moderna: 03/17/21, second dose: Moderna 04/14/21, and third dose Moderna Bivalent: 06/01/23. As reported the patient was unable to lift right arm, stated that her legs were numb, and unable to feel pressure when put on right foot. When asked to smile, patient was unable to smile. No information was provided about diagnostic tests and treatment medication. The outcome of the event was reported as not recovered. Age, hypertension, Hyperlipidemia, Anemia, Chronic kidney disease stage 2, Chronic respiratory failure and Takotsubo syndrome are contributors for the events. Concurrent Cerebrovascular accident and Hypertension are confounders for the event Seizure. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live significant follow-up received. LOT number and PQC number updated. On 10-Nov-2023: Live follow-up received with significant information. Patient details, previous vaccine details and suspect product information updated. On 10-Nov-2023: Live follow-up received with significant information. Patient, reporter details, medical history, concomitant medications, lab data, events and narrative updated. On 13-Nov-2023: Live follow-up received that contains significant information: Reporter and Reference ids updated 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 US-MODERNATX, INC.-MOD-2023-749732:Non Retain case