Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: Pulmonary embolism; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; Computerised tomogram thorax; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1776885) concerned a 61 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: obesity, and tuna allergy, and other pre-existing medical conditions included: None. The patient experienced drug allergy when treated with fentanyl, and cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, frequency 1 total administered on 01-APR-2021 for an unspecified indication. Drug start period were 193 days. The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  Concomitant medications included hydrochlorothiazide.  On 11-OCT-2021, the patient had computerised tomogram thorax and experienced pulmonary embolism and covid-19 (concluded as suspected clinical vaccination failure) and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: Chest computerised tomogram (CT) (NR: not provided) Unknown. It was reported that the patient visited emergency room. Numbers of days hospitalized were not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from covid-19, computerised tomogram thorax, and pulmonary embolism, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality compliant: 90000199064. 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 was received from central complaint vigilance department on 03-NOV-2021. The following information was updated and incorporated into case narrative: product quality investigation result was added.; Sender's Comments: V1: Additional information received in this version updates: Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20211046167-covid-19 vaccine ad26.cov2.s-pulmonary embolism, covid-19, computerised tomogram thorax. 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). 20211046167-covid-19 vaccine ad26.cov2.s-suspected 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