Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral small vessel ischaemic disease, Computerised tomogram head, Computerised tomogram head abnormal, Condition aggravated, Fatigue
Clinical narrative: Pulmonary embolism; Cerebral small vessel ischaemic disease; Atrial fibrillation; Hypoxia; Lacunar infarction; Aortic dilatation; COVID-19; Condition aggravated; Fatigue; Lung infiltration; Mental status changes; Pain; Pleural effusion; Computerised tomogram head abnormal; Myocardial strain imaging; Angiogram pulmonary abnormal; SARS-CoV-2 antibody test positive; SARS-CoV-2 test positive; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1718935) concerned a 91 year old female of unknown race and ethnicity. Initial information received on 01-OCT-2021 was processed with additional information received on 06-OCT-2021. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's past medical history included: hyperkeratosis lenticularis perstans (HLP), paroxysmal atrial fibrillation, colon cancer remotely post RT and chemotherapy, and colon resection, and concurrent conditions included: hypertension (HTN), Chronic obstructive pulmonary disease (COPD), dementia, and arteriosclerotic heart disease (ASHD), and former smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. 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 08-APR-2021 for an unspecified indication. Concomitant medications included amlodipine 10 mg tablet, one tablet oral daily, metoprolol tartrate 25 mg tablet, one tablet oral every twelve hours, and simvastatin 20 mg tablet, 1 tablet oral daily at bedtime.  On 20-SEP-2021, patient was brought into the hospital for worsening mental status fatigue and body aches in the emergency department patient was found to be in atrial fibrillation, rapid ventricular rate (RVR) was 120s. She was afebrile but was hypoxic on room air (Oxygen saturation) 88 percent. Patient tested positive for covid. Computed tomography angiography (CTA) positive for bilateral infiltrates r greater than L with bilateral effusions and noted to have a small non occlusive embolus of subsegmental branch of right lower lobe with no right heart strain and ascending aortic dilatation no dissection and computed tomography (CT) head shows remote lacunar infarcts and age related small vessel changes. the patient experienced cerebral small vessel ischaemic disease, lung infiltration, pleural effusion, pulmonary embolism, condition aggravated and suspected clinical vaccination failure. It was unspecified if an autopsy was performed. Laboratory data on the same day included: Angiogram pulmonary (NR: not provided) abnormal, Computerised tomogram head (NR: not provided) abnormal, Myocardial strain (NR: not provided) not reported, and SARS-CoV-2 antibody test (NR: not provided) IgM 0 07 and IgG 0 03. Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) Positive. On 20-SEP-2021, the patient died from pulmonary embolism, cerebral small vessel ischaemic disease, atrial fibrillation, hypoxia, lacunar infarction, aortic dilatation, covid-19, condition aggravated, fatigue, lung infiltration, mental status changes, pain, pleural effusion, computerised tomogram head abnormal, myocardial strain imaging, sars-cov-2 antibody test positive, angiogram pulmonary abnormal, and sars-cov-2 test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196325. 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 PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 09-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version updates:  Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20211009613-COVID-19 VACCINE AD26.COV2.S- pulmonary embolism, cerebral small vessel ischaemic disease, atrial fibrillation, hypoxia, lacunar infarction, aortic dilatation, covid-19, condition aggravated, fatigue, lung infiltration, mental status changes, pain, pleural effusion, computerised tomogram head abnormal, myocardial strain imaging, sars-cov-2 antibody test positive, angiogram pulmonary abnormal, and 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. V0 20211009613-COVID-19 VACCINE AD26.COV2.S-Suspected 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: CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE; ATRIAL FIBRILLATION; HYPOXIA; PULMONARY EMBOLISM; LACUNAR INFARCTION; AORTIC DILATATION; COVID-19; CONDITION AGGRAVATED; FATIGUE; LUNG INFILTRATION; MENTAL STATUS CHANGES; PAIN; PLEURAL EFFUSION; COMPUTERISED