Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Computerised tomogram head, Computerised tomogram head abnormal, Death
Clinical narrative: DEATH; UTERINE HAEMORRHAGE; FACIAL PARALYSIS; DYSARTHRIA; COVID-19; MENTAL STATUS CHANGES; MUSCULAR WEAKNESS; RED BLOOD CELL TRANSFUSION; HAEMOGLOBIN DECREASED; SARS-COV-2 TEST POSITIVE; COMPUTERISED TOMOGRAM HEAD ABNORMAL; CEREBROVASCULAR ACCIDENT; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID Unknown) concerned a 70 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: progressive macular hypomelanosis (PMH), significant of HTN (hypertension), type 2 DM (diabetes mellitus), hyperlipidemia, PE (pulmonary embolism), uterine sarcoma, lung metastases, and recurrent TIAs (transient ischemic attacks). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for an unspecified indication. Age at time of vaccination 70 years old. No concomitant medications were reported. Number of days between vaccine administration and onset of the events was reported as: 568 days. On 04-OCT-2022, patient was brought in by EMS (Emergency Medical Services) for altered mentation (mental status changes) and abnormal uterine bleeding (uterine haemorrhage). The patient was admitted to hospital for L MCA stroke (cerebrovascular accident) with slurred speech (dysarthria), facial droop (facial paralysis) and RUE weakness (muscular weakness). The patient had history of multiple strokes since SEP-2022 and presented with significant AUB (uterine haemorrhage) with Hb of 6 (haemoglobin decreased). The patient received 2 units pRBC (red blood cell transfusion) in ED (emergency department). CT (computerized tomography) head showed findings suggestive of recurrent stroke. Patient and family requested comfort care only. Hospice consulted initially not in hospital candidate as symptoms were adequately managed by palliative care Comfort medications were started and patient was kept comfortable. On 04-OCT-2022, the patient experienced covid-19 (sars-cov-2 test (severe acute respiratory syndrome coronavirus 2) positive). Laboratory data included: Computerised tomogram head abnormal, Haemoglobin Decreased, Laboratory test Micro - detected, SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test Positive, and SARS-CoV-2 test COVID-19. Laboratory data (dates unspecified) included: Haemoglobin 6 (units unspecified), and head CT findings suggestive of recurrent stroke.  On 01-NOV-2022, the patient died from covid-19, cerebrovascular accident, computerised tomogram head abnormal, dysarthria, facial paralysis, haemoglobin decreased, mental status changes, muscular weakness, red blood cell transfusion, sars-cov-2 test positive, and uterine haemorrhage. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint Unknown. 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. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint department on 08-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V3: This follow up adds information about Product quality complaint investigation result. This does not alter previous causality assessment of the reported events. Death, cerebrovascular accident, computerised tomogram head abnormal, covid 19, dysarthria, facial paralysis, haemoglobin decreased, mental status changes, muscular weakness, red blood cell transfusion, sars-cov-2 test positive, and uterine haemorrhage. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; CEREBROVASCULAR ACCIDENT; COMPUTERISED TOMOGRAM HEAD ABNORMAL; DYSARTHRIA; FACIAL PARALYSIS; HAEMOGLOBIN DECREASED; MENTAL STATUS CHANGES; MUSCULAR WEAKNESS; RED BLOOD CELL TRANSFUSION; SARS-COV-2 TEST POSITIVE; UTERINE HAEMORRHAGE