Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine, Blood immunoglobulin G, COVID-19, Death, Dependence on respirator
Clinical narrative: DEATHS; CONFIRMED COVID-19 INFECTION; PATIENTS PLACED ON VENTILATOR; This solicited literature report received from a health care professional via non-company sponsored study COV19VAC-NONCOMP: Jansen COVID 19 Non-Company Solicited Study. These patients were also referenced in literature. This report concerned multiple patients (12 patients) of unspecified age, sex, race and ethnic origin.  The purpose of this study was to determine the outcomes of breakthrough COVID-19 infections in patients with hematologic malignancies. The patient's height, and weight were not reported. The patient's concurrent conditions included: BCL (b cell lymphoma: vaccinated patient 131 (54 percent), Chronic lymphocytic leukemia vaccinated patient 54 (23 percent), Low-grade BCL vaccinated patient 44 (18 percent), High-grade BCL vaccinated patient 33 (14 percent) , plasma cell dyscrasia vaccinated patient 37 (15 percent), myelodysplastic syndrome vaccinated patient 31 (13 percent), acute myeloid leukemia vaccinated patient 31 (13 percent), myeloproliferative neoplasm vaccinated patient 18 (7 percent), chronic myeloid leukemia vaccinated patient 18 (7 percent), acute lymphoblastic leukemia vaccinated patient 8 (3 percent), hodgkin lymphoma vaccinated patient 8 (3 percent), t-cell leukemia vaccinated patient 7 (3 percent), lymphoma vaccinated patient 7 (3 percent). The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. A retrospective review of a total of 418 patients with hematologic malignancies were reported, where patients contracted COVID-19 between DEC-2020 (after the availability of vaccinations) and 31-OCT-2021. The study included 243 vaccinated patients that developed breakthrough COVID-19 infections and 175 unvaccinated individuals, before the emergence of the Omicron variant but encompassing the time frame over which the Delta variant became predominant. The type of immunization was available for 224 patients (92.2 percent) and of which 12 (4.9 percent) patients were vaccinated with covid-19 vaccine ad26.cov2.s. The number of vaccine doses received before COVID-19 infections was known in 241 patients (99.2 percent) with a median of 2 doses (range, 1 to 3 doses) and a median time of 5.1 months (range, 0.1 to 10.2 months) from the time of last vaccination to COVID-19 infection. The median follow-up time for the entire patient cohort was 3.9 months, and 19 patients did not have follow-up information after the date of COVID-19 infection. 31 (13 percent) vaccinated patients were untreated, 150 (62) vaccinated patients were in remission, 62 (26 percent) vaccinated patients were in remission were with active disease, 121 (50 percent) vaccinated patients were on active therapy, 46 (19 percent) vaccinated patients had received stem cell transplantation/cellular therapy. The baseline laboratory values in vaccinated patients included, White blood cell: median value 5.3 10x3/uL (range from 0.2 to 102.3), absolute neutrophil count: median value 3.1 10x3/uL (range from 0.0 to 41.1), Hemoglobin: median value 12.6 g/dL (range from 5.5 to 17.5), Platelets: median value 177 10x3/uL (range from 1 to 600), Creatinine: median value 1.0 mg/dL (range from 0.4 to 5.1), Immunoglobulin G: median value 730 mg/dL (range from 71 to 5230). Vaccinated patients tended to be older with more comorbidities by the modified CCI (Charlson Comorbidity Index), whereas more unvaccinated patients underwent stem cell transplantation or cellular therapy, with lower hemoglobin levels. The patient had a positive COVID-19 molecular or antigen test who developed COVID-19 related illness (confirmed covid-19 infection). The covid-19 directed therapies in vaccinated patients included, Remdesivir 60 patients (25 percent), Dexamethasone 45 patients (19 percent), Methylprednisolone 25 patients (10 percent), Tocilizumab 15 patients (6 percent), Monoclonal antibodies 90 patients (37 percent). Among the patients who received COVID-19 directed therapies, unvaccinated patients more frequently received all therapies, with a statistically significant difference in remdesivir (P equal to 0.003) and methylprednisolone (P equal to 0.02) use, but more vaccinated patients received monoclonal antibodies (P equal to 0.04). This was consistent with the observed severity differences in infection, unvaccinated patients tended to be sicker and require admission to hospitals, in which remdesivir and methylprednisolone were used; vaccinated patients were more likely to had milder illness and thus received monoclonal antibodies with subsequent discharge from the emergency room without hospitalization. A total 12 vaccinated patients (4.9 percent) required mechanical ventilation during their COVID-19 associated hospitalizations. The admission date, discharge date and duration of hospitalization were unknown. The median length of stay was 5 days for both the vaccinated and unvaccinated patients. There were 47 deaths owing to any cause, in which 24 deaths among vaccinated patients, resulting in rates of death of 9.9 percent. Among these, 32 deaths were due to COVID-19 infections. It was reported that deaths were due to COVID-19 infections and deaths because of any cause. The patients died of unknown cause of death also. It was unspecified if an autopsy was performed.  Regarding COVID-19 associated deaths, 17 occurred in the vaccinated cohort (rate of death, 7.0 percent, 95 percent CI, 4.3 to11.1). Predicted benefit of vaccination was an absolute decrease in the probability of death from COVID-19 infections by 2.3 percent. The predicted benefit of vaccination was an absolute decrease in the probability of hospitalization from COVID-19 infections by 22.9 percent. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause and confirmed covid-19 infection on an unspecified date, and the outcome of patients placed on ventilator was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deaths, confirmed covid-19 infection, and patients placed on ventilator was not related. The author concluded that this pre-Omicron era retrospective study demonstrated that SARS-CoV-2 vaccination in patients with hematologic malignancies had a modest impact on COVID-19 related mortality, with a predicted benefit of a 2.3 percent absolute decrease in the probability of COVID-19 associated death (not reaching statistical significance), but a large absolute reduction in risk of hospitalization. Although the rates of death are lower than previously reported, mortality remained high for patients with hematologic malignancies who contracted COVID-19. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20231073465-Deaths. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related. 20231073465- Confirmed covid-19 infection, patient placed on ventilator. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19 INFECTION; UNKNOWN CAUSE OF DEATH