Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Subcutaneous emphysema
Clinical narrative: Pulmonary embolism; COVID-19 pneumonia; Pneumomediastinum; Angiogram pulmonary abnormal; Anticoagulant therapy; Subcutaneous emphysema; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID:1662854) concerned a 61 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: gastroesophageal reflux disease (GERD), and hypercholesteremia, and other pre-existing medical conditions included: No known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total was administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included apixaban, escitalopram oxalate, rosuvastatin calcium and omeprazole for drug used for unknown indication. On 29-JUL-2021, the patient underwent COVID-19 polymerase chain reaction (PCR) test which was found to be positive (Sars-cov-2 test positive; confirmed clinical vaccination failure). On 05-AUG-2021, he experienced pulmonary embolism, Covid-19 pneumonia, pneumomediastinum, angiogram pulmonary abnormal, anticoagulant therapy, subcutaneous emphysema. He was fully vaccinated and tested positive for Covid-19 (confirmed clinical vaccination failure). He was hospitalized for 16 days. Laboratory data (dates unspecified) included: computed tomography (CT) scan (NR: not provided) computed tomography angiography (CTA) positive for pulmonary embolism. Patient was having antibiotics for pseudomonal pneumonia. Treatment medications (dates unspecified) included: dexamethasone for unknown indication and apixaban for pulmonary embolism.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram pulmonary abnormal, anticoagulant therapy, Covid-19 pneumonia, pneumomediastinum, pulmonary embolism, Sars-cov-2 test positive, subcutaneous emphysema and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000193187. 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 17-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result were added.; Sender's Comments: V1: The follow up information in this version updates Product quality complaint investigation result, vaccine dose. This updated information does not alter the causality of previously reported events.   20210920388-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  20210920388-Covid-19 vaccine ad26.cov2.s-Angiogram pulmonary abnormal, anticoagulant therapy, covid-19 pneumonia, pneumomediastinum, pulmonary embolism, sars-cov-2 test positive, subcutaneous emphysema. 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).