Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Heart sounds abnormal, Pulse absent
Clinical narrative: seizures or seizure like activity; Chest pain; hypo or hypertension; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizures or seizure like activity), CHEST PAIN (Chest pain) and BLOOD PRESSURE FLUCTUATION (hypo or hypertension) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot 017B21A Exp. 09/14/21) on 29-Mar-2021, Moderna COVID-19 vaccine (Lot 017B21A Exp. 09/14/21) on 26-Apr-2021, Moderna COVID-19 vaccine (Lot 012F21A Exp. 11/13/21) on 28-Oct-2021 and Moderna COVID-19 vaccine (Lot 017B22A Exp. 07/27/22) on 24-Jun-2022; for Product used for unknown indication: Pfizer (Lot GH9703 Exp. 10/21/22) on 22-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Pfizer. Concurrent medical conditions included Drug allergy, Allergic reaction to antibiotics, Drug allergy, Iodine allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Allergic reaction to antibiotics, Drug allergy, Drug allergy, Allergic reaction to antibiotics, Drug allergy, Allergic reaction to analgesics, Penicillin allergy, Drug allergy, Sulfonamide allergy, Shellfish allergy, Contrast media allergy, Drug allergy, Allergy to chemicals, Hypertension, Hypothyroidism, Fluid retention, Diabetes mellitus, Shortness of breath, Pain, Depression, Vitamin D deficiency, Dry eye, AFib, CVA and Intestinal functional disorder. Concomitant products included APIXABAN for AFib and CVA, ESCITALOPRAM OXALATE for Depression, INSULIN GLARGINE (LANTUS SOLOSTAR) for Diabetes mellitus, FUROSEMIDE (LASIX [FUROSEMIDE]) for Fluid retention, CARVEDILOL and LOSARTAN POTASSIUM for Hypertension, LEVOTHYROXINE SODIUM for Hypothyroidism, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]) for Intestinal functional disorder, ACETAMINOPHEN and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE) for Shortness of breath, ERGOCALCIFEROL for Vitamin D deficiency.    On 08-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures or seizure like activity) (seriousness criteria death and medically significant), CHEST PAIN (Chest pain) (seriousness criterion death) and BLOOD PRESSURE FLUCTUATION (hypo or hypertension) (seriousness criterion death). The patient died on 09-Nov-2023. The reported cause of death was Chest pain, hypo or hypertension and seizures or seizure like activity. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  The patient had chest pains, hypo or hypertension and seizures or seizure like activity.  On 09-Nov-2023, the patient was passed away.  Company Comment: This fatal spontaneous case concerns a 83-year-old female patient with medical history  of Moderna and Pfizer COVID-19 Vaccines (without adverse events), Concomitant products included APIXABAN for AFib and CVA, ESCITALOPRAM for Depression, INSULIN for Diabetes mellitus, FUROSEMIDE  for Fluid retention, CARVEDILOL and LOSARTAN for Hypertension, LEVOTHYROXINE for Hypothyroidism, LACTOBACILLUS ACIDOPHILUS for Intestinal functional disorder, ACETAMINOPHEN, HYDROCODONE, PARACETAMOL for Pain, IPRATROPIUM, SALBUTAMOL for Shortness of breath, ERGOCALCIFEROL for Vitamin D deficiency who experienced the unexpected seriousness criteria death and medically significant AESI of seizure; the seriousness criteria death unexpected events of chest pain and blood pressure fluctuation in the context of 6th. dose of mRNA-1273.815 vaccine. As the patient received doses of Pfizer vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. The patient received the mentioned dose on November, 08, 2023 and death occurred on November 9th. The reported cause of death was Chest pain, hypo or hypertension and seizures or seizure like activity.  It is unknown if an autopsy was performed. The medical history and age are confounders for the events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140 (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: Dose details added. On 10-Nov-2023: Live follow-up received: medical history and concomitant medication was added. On 13-Nov-2023: Live follow-up received with 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; Reported Cause(s) of Death: Chest pain; hypo or hypertension; Seizures or seizure like activity