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Write-up: DEATH; BREAKTHROUGH COVID CASES; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient by other company (Pfizer Inc.) received on 23-JUL-2021 and concerned multiple patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Concomitant medications included bnt 162, and mrna 1273. It was reported that there were 4450 breakthrough Covid cases. Among 4450 cases, 247 patients were hospitalized for suspected Covid 19 infection and 79 patients died among the population who were fully vaccinated by Pfizer or Moderna vaccine both doses or Janssen vaccine one dose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of breakthrough covid cases and suspected covid 19 infection was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210756412-covid-19 vaccine ad26.cov2.s-death,breakthrough covid cases. This event(s) is considered unassessable. The event(s) 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(s). 20210756412-covid-19 vaccine ad26.cov2.s -suspected covid 19 infection. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.; Reported Cause(s) of Death: CONFIRMED COVID-19 INFECTION
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