Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away 2 hours post vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Patient passed away 2 hours post vaccine administration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalized.) in February 2022. Concurrent medical conditions included Drug allergy (Allergic to Niacin), Drug allergy (Allergic to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer. Concomitant products included METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ASPIRIN [ACETYLSALICYLIC ACID], DONEPEZIL HYDROCHLORIDE (ARICEPT), PANCREATIN (CREON), ROSUVASTATIN CALCIUM (CRESTOR), FENOFIBRATE, LEVOTHYROXINE SODIUM (SYNTHROID), QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. Death occurred on 03-Aug-2022 The patient died on 03-Aug-2022. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first and second boosters on 18-Jan-2022 and 03-Aug-2022 respectively.  Patient was monitored for 15 minutes after administration and had no reactions. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause patient to seek medical care.  No treatment information was provided.  Company Comment: This fatal spontaneous case concerns a 70-year-old female patient with medical history of  Covid-19 on February 2022, Drug allergy  (to Niacin and to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer, Concomitant products included METOPROLOL, INSULIN, MEMANTINE, ACETYLSALICYLIC ACID, DONEPEZIL, PANCREATIN, ROSUVASTATIN, FENOFIBRATE, LEVOTHYROXINE, QUETIAPINE, SERTRALINE and VALPROATE  who experienced the unexpected (seriousness criteria death and medically significant) event of death the same day of the 4th. dose of Moderna Covid 19 vaccine. Also, there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case.  The reported cause of death is unknown. It is unknown if an autopsy was performed The medical history, age and concomitant medications are confounders for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-628582, MOD-2022-628590 (Patient Link).; Sender's Comments: This fatal spontaneous case concerns a 70-year-old female patient with medical history of  Covid-19 on February 2022, Drug allergy  (to Niacin and to Imitrex), Diabetes, Chronic heart failure, Hypothyroidism and Colon cancer, Concomitant products included METOPROLOL, INSULIN, MEMANTINE, ACETYLSALICYLIC ACID, DONEPEZIL, PANCREATIN, ROSUVASTATIN, FENOFIBRATE, LEVOTHYROXINE, QUETIAPINE, SERTRALINE and VALPROATE  who experienced the unexpected (seriousness criteria death and medically significant) event of death the same day of the 4th. dose of Moderna Covid 19 vaccine. Also, there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case.  The reported cause of death is unknown. It is unknown if an autopsy was performed The medical history, age and concomitant medications are confounders for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of Death