Sex: U
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: BREAKTHROUGH COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; DEATH; This spontaneous report was received from literature. Initial information was processed along with the additional information received on 19-APR-2022.  The objective of this study was to describe that the Heart transplant (HT) recipients are at high risk for Covid-19 infection, and data are limited about the efficacy of vaccination in this unique population. The authors sought to describe the presentation and outcomes of a cohort of HT patients with Covid-19 infection despite prior vaccination. A total of 237 were vaccinated with an incidence of 7 breakthrough infections (3%). The average BMI was 32.89. Hypertension (86%), diabetes (57%), and hyperlipidemia (43%) were common. Nearly all (71%) of patients were on 3 classes of immunosuppressive therapy, and nearly half (43%) had a history of rejection. Five patients (72%) received Pfizer-BioNTech, 1 patient (14%) received Moderna, and 1 patient (14%) received the Johnson & Johnson vaccination. One patient had a prior history of Covid-19 infection before vaccine availability. Patients were on average 6.74 (3.8-8.4) years out from transplantation. The most common presentation was dyspnea (71%), cough (57%), and fever (43%). Seventy one percent were hospitalized, and 29% were admitted to the ICU. Treatments varied, with equal rates of antibiotics (29%), steroids (29%), and remdesevir (29%). However the most common treatment was monoclonal antibody therapy (57%). This report concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: heart transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The patient had not taken any booster dose. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough covid-19 infection, and had suspected clinical vaccination failure and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) positive. Duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough covid-19 infection and suspected clinical vaccination failure was not reported and on an unspecified date, the patient died from from unknown cause. It was unspecified if an autopsy was performed. The authors concluded that In a single center experience 7 patients with a history of heart transplant and breakthrough Covid-19 infection were identified and found to have an 86% survival rate as One patient, vaccinated with a single Johnson & Johnson shot, died lending an 86% survival rate for breakthrough infections after Covid-19 vaccination. They added that a further investigation is needed assessing the efficacy of the Covid-19 vaccination in this population (Heart Transplant Recipients), as well as evaluation for differential outcomes between the various vaccine options. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000226758.; Sender's Comments: V0:20220427782-covid-19 vaccine ad26.cov2.s -?Death,Breakthrough covid 19 infection.The event(s) has a unknown/unclear 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.Therefore, this event(s) is considered unassessable.  20220427782-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure.The event(s) has a unknown/unclear 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.This event(s) is considered not related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH