Reporte zur Charge 207A21A92121

Symptomtext

BLOOD CLOTS; TERRIBLE PAIN/HORRIBLE PAIN; DIARRHEA; THROWING IT UP/THROWING UP BILE; FEELS LIKE HAVING HEART ATTACK; DOUBLE VISION; CAN NOT WALK; CANNOT SEE; EXTREMELY DIZZY; BLADDER PROLAPSE WORSENED; COULD NOT BREATHE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: tarlov cysts (Patient had this very rare condition, and had a procedure performed for this condition), laminectomy on 16-JUN-2021 (was 8 hours long, consisted of taking two masses out of her spine), and abscess on 04-JUL-2021 (she had a bright red incision and was told to get to nearest hospital. A surgeon did an MRI (Magnetic Resonance Imaging) and saw she had an abscess. Per patient, she had a tube placed in, and there was pain. When the tube came out, it did something to her bladder, and she was sent home with a catheter. Patient was bleeding and very sick.), She said she has also had three major surgeries and concurrent conditions included: bladder prolapse (She recalled that without an anesthetic, a doctor put steroids inside the vaginal wall into her bladder muscle. Patient said that made it ten times worse for pain, and her bladder would not function. Patient reported the doctor who performed the procedure will not call her back and he said he didn't do anything wrong. Patient was told she had bladder prolapse, and she had Botox placed in her bladder). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number : 207A21A92121 and expiry date was not reported) dose was not reported, 1 total administered on 29-JUL-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 71 years old. No concomitant medications were reported. On an unspecified date in SEP-2021, two months after vaccination, the patient experienced blood clots, and was hospitalized (date unspecified) for a whole month. Patient discussed another situation where they found blood clots in in March or April or 2022 (unspecified date) after she had an hour and a half plane flight. On an unspecified date in MAY-2023, the patient experienced could not breathe, and four weeks ago before reporting she had bladder prolapse worsened. She had a stimulator placed in her bladder. She started throwing urine everywhere and was in terrible pain. The patient went to the emergency room the next day because patient could not breathe. Patient explained she has been placed on rivaroxaban, and it started doing the same thing as when she was on Eliquis. She described that fifteen minutes after taking the medicine, she starts throwing up bile. Morning and night, she is getting diarrhea and having terrible pain. Patient explained she has been placed on rivaroxaban, and it started doing the same thing as when she was on Eliquis. She described that fifteen minutes after taking the medicine, she starts throwing up bile. Morning and night, she was getting diarrhea and having terrible pain in her stomach. Patient said they kept sticking her back in the hospital, and her bladder was not fixed. Patient reported that for some reason, her body was rejecting all of these medicine. Patient has previously been on heparin, and she mentioned she was vomiting from anesthetics. Then, she was placed on Eliquis, and from that Thursday night through the weekend (unspecified date), she was in horrible pain. She ended up in the emergency room again, and was told she had accumulated another blood clot. Patient was in the hospital for a whole month. She was given heparin again. She also had a f-factor test performed. She described that the next day she couldn't breathe. The cardiologist thought she saw something in the patient's blood, and they gave her a nuclear testing, which showed she was not typed to have blood clots. The patient received treatment medication rivaroxaban (film-coated tablet, batch number: 22C6341 expiry: JUN-2024) 15 mg, 1 time every .5 days, from 31-MAY-2023 for blood clots. Additional treatment medications (dates unspecified) included: heparin, and apixaban. Patient said she had a doctor who attributes her blood clot to the Janssen vaccine while another doctors thinks it was from the surgery she had. Patient had been on rivaroxaban, but she only took it once daily for 30 days, then the blood clots were gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots, had not recovered from could not breathe, and the outcome of feels like having heart attack, throwing it up/throwing up bile, double vision, can not walk, cannot see, extremely dizzy, diarrhea, bladder prolapse worsened and terrible pain/horrible pain was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20230622652. This case, from the same reporter is linked to 20230606535.; Sender's Comments: V0: 20230629380-Blood clots. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.