Sex: F
Vaccine: COVID19, FLUX
Symptoms: Heart rate increased, Illness, Insomnia, Loss of personal independence in daily activities, Lymphoedema
Clinical narrative: headaches/head hurts; heaving trying to throw up; sick could barely get out of bed; so sick the next day that I could barely get out of bed; fatigue; Blurry vision/ blurred vision; Trying to throw up/Vomiting; weakness; hear crackling in my ears; insomnia; stuffy nose; pain in lower back; pain in shoulder; 160/95-107; bright red, rashy  "face looks like an apple", arms, legs, under breast/ rashes; Shakes/ shakes on the outside shaking on the inside/ shaking hands; Nausea, nausea medication does help/Nausea/ nausea with heaving; Dizzy/ when I get up, I have to get up slowly/ dizziness; pulse  runs 85-105 which is also high for her/ rapid heart beat; legs were big because of lymphedema; This case was reported by a consumer via patient support programs and described the occurrence of increased blood pressure in a female patient who received niraparib (Zejula) capsule (batch number 2057808, expiry date 30th June 2024), (batch number 2416866, expiry date 30th June 2024), (batch number 2416866, expiry date 30th September 2024) and (batch number 2342677, expiry date 30th June 2024) for malignant peritoneal neoplasm.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 1st September 2022, the patient started Zejula 300 mg once daily (300 mg daily). On an unknown date, the dose was changed to 2 dosage form(s) once daily (2 dosage form(s) daily). On an unknown date, the dose was changed to 300 mg once daily (300 mg daily). On an unknown date, the dose was changed to 300 mg once daily (300 mg daily). On an unknown date, the dose was changed to 300 mg once daily (300 mg daily). On an unknown date, the patient received Flu vaccine and COVID-19 BOOSTER. In September 2022, an unknown time after starting Zejula and not applicable after receiving Flu vaccine, the patient experienced increased blood pressure, red rash, tremor, nausea, dizziness, pulse increased and lymphedema. On an unknown date, the patient experienced headache, retching, sickness, activities of daily living impaired, fatigue, blurred vision, vomiting, weakness, ear discomfort, insomnia, nasal congestion, low back pain and shoulder pain. The patient was treated with paracetamol (Tylenol). The dose of Zejula was increased. On an unknown date, the outcome of the increased blood pressure, lymphedema, sickness, activities of daily living impaired, vomiting, weakness, ear discomfort, low back pain and shoulder pain were unknown and the outcome of the red rash, tremor, nausea, dizziness, pulse increased, headache, retching, fatigue, blurred vision, insomnia and nasal congestion were not recovered/not resolved.   It was unknown if the reporter considered the increased blood pressure, red rash, tremor, nausea, dizziness, pulse increased, lymphedema, headache, retching, sickness, activities of daily living impaired, fatigue, blurred vision, vomiting, weakness, ear discomfort, insomnia, nasal congestion, low back pain and shoulder pain to be related to Zejula. It was unknown if the reporter considered the sickness and activities of daily living impaired to be related to Flu vaccine.     Additional Information:  Receipt Date: 28-SEP-2022 Reporter's Comments: This information was received from consumer via company. Patient reported blood pressure 160/95-107; stated her pulse runs 85-105 which was also high for her; bright red, rashy; face looks like an apple, arms, legs, under breast; shakes when she get up, she had to get up slowly; nausea and dizzy; her legs were big because of lymphedema, but since Zejula legs were normal as blueberry pie.  Follow up information was received on 27 Oct 2022, 02 Nov 2022. Reporter's comments : This case was received from consumer via company. The patient stated she took 2 capsules a day for a while as per her Oncologist orders but then went back to the 3 capsules per day. She had headaches but Tylenol takes care of it later a while, Sometimes patient was heaving and tried to throw up, it was nausea but the nausea medication did help. She had rashes. She had the shakes on the outside, then they were gone but felt like she was shaking on the inside. Patient took her Covid booster and flu shot on the same day and was so sick the next day that she could barely get out of bed. Patient reported many side effects while taking 300mg dosing which included fatigue, blurry vision, nausea , vomiting, dizziness, and weakness. Patient also stated She Heard crackling in her ears and her head hurts. It was unknown if the reporter considered activities of daily living impaired ,Sickness to be related to Covid 19 vaccine. 1 day after receiving Flu vaccine and Covid-19 vaccine, the patient experienced sickness and activities of daily living impaired.    Follow up information received on 02 Nov 2022 Reporters comment: This information was received from consumer via company. The reporter was the patient. She was currently in remission from ovarian cancer and is taking Zejula. She started 2 months ago on Zejula 200mg daily and took that dose for 4 weeks. Then, she increased to 300mg daily four weeks ago. One day following the increased dose she began experiencing dizziness, fatigue, insomnia, nausea with heaving, stuffy nose, blurred vision, pain in the lower back and shoulder, rapid heart beat and shaking hands which has continued throughout the course of treatment. Consented to follow up.It was unknown if the reporter considered  insomnia, nasal congestion,low back pain and shoulder pain to be related to Covid 19 vaccine.   Summary of changes: lab data, Events added