Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fall, Fatigue, Head injury, Hypersensitivity
Clinical narrative: PNEUMONIA; SEPTIC; DON'T FEEL GOOD; ALLERGIES; FATIGUE; PASSED OUT; FELL; HIT HER HEAD; WASN'T GIVEN FLUIDS AFTER THEY TOOK BLOOD; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: respiratory syncytial virus/pneumonia, delirious, short term memory loss, can no longer drive, and very severe sick period, and concurrent conditions included: urinary tract infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number: 8053457 expiry: 31-DEC-2021, batch number: 8782351 expiry: 31-DEC-2021, batch number: 8434861 expiry: 28-FEB-2020, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135784 expiry: 28-FEB-2023) 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 09-FEB-2018, and 20 mg, 2 times every 1 day, from 10-FEB-2018 for polycythemia vera. No concomitant medications were reported.  On an unspecified date, the patient, experienced allergies and pneumonia. The patient also missed doses (unspecified). It was reported that the patient had urinary tract infection (UTI) back in the winter that made her septic. The patient did not know what was going on. The patient did not feel good. On an unknown date in APR-2021, the patient passed out, fell, and hit her head because she was not given fluids after they took blood. The emergency medical services (EMS) transported patient to the emergency room (ER) where she was given fluids and was discharged home. On 13-AUG-2021, the patient mentioned she was now given 1000mL of saline when getting blood drawn. On an unspecified date, the patient experienced fatigue since coronavirus disease (COVID) shot.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ruxolitinib phosphate was withdrawn. The outcome of the passed out, fell, hit her head, wasn't given fluids after they took blood, pneumonia, septic, fatigue, don't feel good and allergies were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210841850 - covid-19 vaccine ad26.cov2.s -Pneumonia , Septic. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: MEDICAL HISTORY 20210841850 - covid-19 vaccine ad26.cov2.s -Passed out , Fell ,Hit her head, Wasn't given fluids after they took blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).