Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, COVID-19 pneumonia, Cardiac murmur, Hypertension
Clinical narrative: COVID-19 PNEUMONIA; PULMONARY EMBOLISM; COVID-19; CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; HYPERTENSION; CARDIAC MURMUR; This spontaneous report received from a health care professional (reference number: 1913361) concerned a 66 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and pancreatitis, and other pre-existing medical conditions included: The patient had diabetes due to pancreatitis. The patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered to the left arm on 12-APR-2021 for an unspecified indication. Dose number in series 1. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included insulin, statin and daily vitamin.  Patient was preparing to do the booster but patient ended up with a covid-19 breakthrough infection and admitted to hospital 16-NOV-2021 to 19-NOV-2021, number of days hospitalized was 3. Diagnosed with covid-19 pneumonia, confirmed clinical vaccination failure and a pulmonary blood clot. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. Subsequent with primary care physician follow up, on 01-DEC-2021 patient have high blood pressure 200/101 mmHg and a heart murmur. The heart murmur was not heard during the hospitalization, patient believe this was the result of the covid-19 infection perhaps compounded by vaccination. Laboratory data included: Blood pressure (NR: not provided) 200/101 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19, covid-19 pneumonia, cardiac murmur, hypertension, pulmonary embolism, and sars-cov-2 test positive, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000206828. 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 on 21-DEC-2021. The following information was updated and incorporated in to the case narrative: Product quality complaint investigation result. Upon review following information was amended: medically confirmed field updated from blank to manual check box (checked).; Sender's Comments: V1: Additional information in this version is regarding: Product quality complaint investigation result. Upon review following information was amended: medically confirmed field updated from blank to manual check box (checked). This does not alter company causality of previously reported events 20211225686-covid-19 vaccine ad26.cov2.s-covid-19, covid-19 pneumonia, hypertension, pulmonary embolism, and 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).  20211225686-covid-19 vaccine ad26.cov2.s-confirmed 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