Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: DEATH; PULMONARY EMBOLISM; COVID-19; SARS-COV-2 TEST POSITIVE; VOMITING; DIARRHOEA; AUTOPSY; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1624304) concerned a 51 year old female patient of unspecified race and ethnic origin.   The patient's height, and weight were not reported. The patient's concurrent conditions included: congenital adrenal hyperplasia, 21-hydroxylase deficiency, CVA (Cerebrovascular accident), white matter periventricular infarction, meningioma, lung nodule, hyperlipidemia, gastritis, gastroduodenitis, GI (Gastrointestinal) AVM (Arteriovenous malformation), GI bleed, melena, and diverticulosis, and the patient had no other current illness. The patient experienced drug allergy when treated with acetylsalicylic acid (Aspirin), codeine, escitalopram, etodolac (Lodine), olanzapine (Zyprexa), Olanzapine and risperidone for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: Unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included calcium, denosumab (Prolia), dexamethasone, ergocalciferol (Vitamin D), lorazepam (Ativan), loxapine succinate (Loxitane), magnesium, omeprazole (Prilosec), potassium chloride, prazosin hydrochloride (Minipress), quetiapine fumarate (Seroquel) and sertraline hydrochloride (Zoloft) used for unknown indication.  On 03-AUG-2021, the patient experienced diarrhoea, vomiting (till 09-AUG-2021 and tested positive for COVID-19 (Coronavirus) via SARS-CoV-2 test. On the same day the patient experienced pulmonary embolism. On 09-AUG-2021, the patient was found dead at her residence. On an unspecified date in AUG-2021 an autopsy was performed, and pulmonary embolism was found to be the cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death, pulmonary embolism, autopsy, covid-19, diarrhoea, vomiting and SARS-CoV-2 test positive was fatal. This report was serious (Death). This report was associated with product quality complaint: 90000192669. The suspected product quality complaint has been confirmed to be undetermined. 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 was received from Central Complaint Vigilance on 23-SEP-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was updated. Upon review, the following information was amended: labeling for the events vomiting and diarrhea was updated from labeled to unlabeled.; Sender's Comments: V3: The follow up information in this version updates: Product complaint investigation result, Labelling of events vomiting and diarrhea updated. This updated information does not alter the causality of previously reported events.  20210907659-Covid-19 vaccine ad26.cov2.S- Pulmonary embolism, Death, Autopsy, Covid-19, Diarrhoea, Vomiting, 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).; Reported Cause(s) of Death: PULMONARY EMBOLISM