Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Cough, Death, Deep vein thrombosis
Clinical narrative: DEATH; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; COVID-19; CONFUSIONAL STATE; COUGH; DYSPNOEA; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 2006349) concerned a 77-year-old female of unspecified race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: Hypertension (HTN), Rheumatoid arthritis (RA), Gastroesophageal reflux disease (GERD), restless leg syndrome and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 01, 01 total was administered on 07-MAR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-SEP-2021, the patient was brought to emergency department (ED) with increasing shortness of breath (SOB)/ dyspnoea, and confusion (confusional state) and was put on oxygen (O2) via nasal cannula (NC). She was found to have a deep vein thrombosis (DVT) in left upper extremity and pulmonary embolism (PE) in right lower lung, she was also positive for coronavirus disease (COVID-19) [Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test was positive], and she had coughing. The patient was hospitalized on the same day. She was placed on Airvo 55L 91% fraction of inspired oxygen (FiO2) and treatment medications (dates unspecified) included: methylprednisolone sodium succinate (solu-medrol), remdesivir, and baricitinib. The patient's condition worsened on unspecified date and she was placed on comfort measures without aggressive treatments. (dose number in series was 01). On 11-SEP-2021, the patient died in the hospital. The exact cause of death was unknown. On same day, the patient was discharged after 8 days of hospitalization. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confusional state, cough, death, deep vein thrombosis, covid-19, dyspnoea, pulmonary embolism, SARS-CoV-2 test positive was reported as fatal. This report was serious (Death, Hospitalization Caused / Prolonged). This report is associated with product quality complaint (PQC): 90000212625. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the product quality complaint (PQC) evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 24-JAN-2022 The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.This updated information does not alter the causality of previously reported events. 20220126152 -COVID-19 VACCINE AD26.COV2.S-Death,Deep vein thrombosis,Pulmonary embolism,Covid-19,Confusional state,Cough,Dyspnoea,SARS-Cov2-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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; COVID-19; CONFUSIONAL STATE; COUGH; DYSPNOEA; SARS-COV-2 TEST POSITIVE