Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: DEATH; CHEST X-RAY ABNORMAL; DIARRHOEA; LUNG OPACITY; MECHANICAL VENTILATION; ACUTE RESPIRATORY DISTRESS SYNDROME; PULMONARY OEDEMA; BRAIN INJURY; COVID-19 PNEUMONIA; CEREBROVASCULAR ACCIDENT; COVID-19; FATIGUE; PYREXIA; CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1940093) concerned a 74 year old female of unknown race and ethnic origin. Initial information was processed along with the additional information received on 27-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic lymphocytic leukemia, and hypertension, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered vaccinated at left arm on 08-MAR-2021 for an unspecified indication (Dose number in series 1). Concomitant medications included acalabrutinib, alprazolam, ascorbic acid (vitamin C), atenolol, fluoxetine, multivitamin, hydrochlorothiazide, and simvastatin.  On 02-DEC-2021, the patient experienced sars-cov-2 test positive. The patient was at hospital for fever, diarrhea, fatigue and was found to be covid positive. Patient was transferred to hospital for further care on 06-DEC-2021. On arrival patient had severe covid ARDS (Acute respiratory distress syndrome) requiring paralysis for lung protective ventilation as well as veletri. Given damage to brain from a stroke that likely occurred 1 to 2 days prior the team felt there was no intervention that could change the patient's prognosis. On 06-DEC-2021, the patient experienced brain injury, covid-19 pneumonia, cerebrovascular accident, lung opacity, pulmonary oedema, pyrexia, fatigue, and confirmed clinical vaccination failure. On 07-DEC-2021, the chest X-ray showed extensive ARDS (Acute respiratory distress syndrome) and fluid in lungs. The patient passed peacefully on 07-Dec-2021. Patient was hospitalized for 1 day. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute respiratory distress syndrome, brain injury, covid-19, covid-19 pneumonia, cerebrovascular accident, chest x-ray abnormal, death, diarrhoea, fatigue, lung opacity, mechanical ventilation, pulmonary oedema, pyrexia, and sars-cov-2 test positive and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged). This case was associated with product quality complaint: 90000208920. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. based on the PQC evaluation/investigation performed.  Additional information was received from a Central Complaint Vigilance on 10-JAN-2022.The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: Follow up information updated : Product quality complaint investigation result. This updated information does not alter the causality of previously reported event. 20211255819-COVID-19 VACCINE AD26.COV2.S-acute respiratory distress syndrome, brain injury, covid-19, covid-19 pneumonia, cerebrovascular accident, chest x-ray abnormal, death, diarrhoea, fatigue, lung opacity, mechanical ventilation, pulmonary oedema, pyrexia, and sars-cov-2 test positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) 20211255819-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: ACUTE RESPIRATORY DISTRESS SYNDROME; BRAIN INJURY; COVID-19; COVID-19 PNEUMONIA; CEREBROVASCULAR ACCIDENT; CHEST X-RAY ABNORMAL; DEATH; DIARRHOEA; FATIGUE; LUNG OPACITY; MECHANICAL VENTILATION; PULMONARY OEDEMA; PYREXIA; SARS-COV-2 TEST POSITIVE