Reporte zur Charge 1805022 HCP

Symptomtext

BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. 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).