Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Asthenia, COVID-19, Cough, Death
Clinical narrative: SARS-COV-2 TEST POSITIVE; DYSPNOEA; COVID-19; ASTHENIA; COUGH; PYREXIA; DEATH; ACUTE MYOCARDIAL INFARCTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [Vaccine Adverse Event Reporting System (VAERS) (ID: 1689428) concerned a 97 year old female. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's concurrent conditions included: dementia, diabetes, blindness, Gastroesophageal reflux disease (GERD), chronic kidney disease, hyperlipidemia, and peripheral vascular disease. The patient experienced confusion when treated with duloxetine, and tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-MAR-2021 on left arm for product use for unknown indication. Concomitant medications included acetylsalicylic acid, amlodipine, ascorbic acid, cimetidine, diclofenac, fish oil, gabapentin, insulin glargine, insulin lispro, latanoprost, linagliptin, macrogol 3350, pravastatin, and zinc.  On 28-AUG-2021, the patient presented to the emergency department with shortness of breath (dyspnea), cough, fevers (pyrexia) and generalized weakness (asthenia). On 28-AUG-2021, the patient had tested positive for COVID-19 (confirmed clinical vaccination failure). The patient was hospitalized for 4 days until she ultimately expired after experiencing an acute myocardial infarction /NSTEMI (non-ST segment elevation myocardial infarction) during admission. On 01-SEP-2021, the patient died from unknown cause of death. Autopsy was unspecified if it was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, acute myocardial infarction, sars-cov-2 test positive, dyspnoea, covid-19, asthenia, cough and pyrexia on 01-SEP-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case was associated with product complaint 90000195065. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified based on the product evaluation/investigation performed.  Additional information was received from Complaint Vigilance department on 18-OCT-2021. The following information was updated and incorporated in to the case narrative: Product complaint investigation result added. Upon review following information was amended: event suspected clinical vaccination failure updated to confirmed clinical vaccination failure.; Sender's Comments: V2: Additional information in this version updates: Product complaint investigation result. Upon review following information was amended: event suspected clinical vaccination failure updated to confirmed clinical vaccination failure. Mac is amended.  20210949934-covid-19 vaccine ad26.cov2.s -Death, Myocardial infarction, Dyspnea, Covid 19, Asthenia, Cough, Pyrexia, Sars-cov-2 test positive. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210949934-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH