Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: COVID-19; DEATH; This solicited report received from a health care professional via literature concerned a multiple female patients of unspecified age. The patients were enrolled in a non-company sponsored study. This patients were also referenced in literature:  The patients weight, height, and medical history were not reported. The patients received treatment with covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Study methods: This retrospective study was designed to compare two potential vaccination regimens. use BNT162b2 versus use Ad26.COV2.S. BNT162b2 was chosen as the comparator messenger RNA vaccine (as opposed to mRNA-1273) because it had better geotemporal overlap with Ad26.COV2.S in the population. The study included patients on dialysis who were aged greater than or equal to 18 years and who received a first dose of BNT162b2 or a dose of Ad26.COV2.S between 27-FEB-2021 and 18-MAY-2021. Furthermore, to promote balance on susceptibility factors, patients receiving BNT162b2 and Ad26.COV2.S were also matched on the site of dialysis care. Study also compared hospitalization and mortality among patients receiving BNT162b2 and Ad26.COV2.S who were diagnosed with COVID-19. To estimate vaccine antibody response to Ad26.COV2.S, they conducted a prospective study among a subset of patients who received Ad26.COV2.S between 27-FEB-2021 and 25-MAR-2021. On an unspecified date, the patients were died (coded as death), and experienced covid-19  (dose series 1), and was hospitalized (date unspecified). The patients died from unknown cause of death. It was unknown if an autopsy was performed. Results: Total of 2572 matched pairs of patients qualified for analysis. Cumulative incidence rates of COVID-19 did not differ for BNT162b2 versus Ad26.COV2.S. No differences were observed in periCOVID-19 hospitalizations and deaths among patients receiving BNT162b2 versus Ad26.COV2.S, who were diagnosed with COVID-19 during the at-risk period. Results were similar when excluding patients with a history of COVID-19, in subgroup analyses restricted to patients who completed the 2-dose BNT162b2 regimen, and in patients receiving in-center hemodialysis. SARS-CoV-2 antibodies were detected in 59.4% of 244 patients who received Ad26.COV2.S. Comparative effectiveness in the primary analytical cohort: There was a total of 158 patients with COVID-19 observed during the at-risk period. Most notably, none of these 158 patients had a history of COVID-19. In the primary analytical cohort, cumulative incidence of COVID-19 during the at-risk period was no different for patients receiving BNT162b2 and Ad26.COV2.S. The corresponding IRD was +0.17 (95% CI, -0.31 to 0.65), indicating no statistically significant difference in COVID-19 incident rates during the at-risk period. On the basis of the confidence limits, with 97.5% certainty, the number of additional COVID-19 diagnoses per week for each 1000 patients adopting a use Ad26.COV2.S (versus a use BNT162b2) would not be expected to exceed 0.65. Among patients who received a COVID-19 diagnosis during the at-risk period, rates of peri-COVID-19 hospitalization and death were not statistically different between BNT162b2 and Ad26.COV2.S groups. Secondary Analysis: In the 46 weeks postvaccination, both patients receiving BNT162b2 and Ad26.COV2.S contributed for COVID-19. IgG antibodies were detected in 59.4% (95% CI, 53.0% to 65.5%) of patients who were vaccinated with Ad26.COV2.S. Conclusions: In a large real-world cohort of patients on dialysis, no difference was detected in clinical effectiveness of BNT162b2 and Ad26.COV2.S over the first 6 months postvaccination, despite an inconsistent antibody response to the latter. In this comparative effectiveness study of patients on maintenance dialysis, we observed no difference in clinical effectiveness between Ad26.COV2.S and BNT162b2. Results were similar when we only considered patients without a history of COVID-19, in whom vaccine effectiveness should therefore be minimally affected by naturally acquired immunity. In summary, study results demonstrate no difference in the clinical effectiveness of BNT162b2 and Ad26.COV2.S over the first 6 months postvaccination in patients on dialysis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of covid-19 was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and death was not related, and between covid-19 vaccine ad26.cov2.s, and covid-19 was not related.  This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0-COVID-19, Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH