Sex: F
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This solicited report received from a consumer via PPSCVM000808: concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with 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. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient advised that she got the vaccine, got a blood clot and then got covid (coded as suspected covid-19 infection, suspected clinical vaccination failure) (Covid was post taking Xarelto). It was not confirmed if other events were before or after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of the suspected covid-19 infection, blood clot and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related; and between rivaroxaban, and blood clot, suspected clinical vaccination failure, and suspected covid-19 infection was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021089-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered not related. 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).  20211021089-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an 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 20211021089-rivaroxaban-Blood clot. This event(s) is considered not related. 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). 20211021089-rivaroxaban-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an 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