Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction, Illness
Clinical narrative: Constipation; A little bit of fatigue; nausea; rash on arms and chest; itching on arms and chest; CA-125 "has been erratic"; drug reaction; was "sick for three days after the shot; This case was reported by a consumer via patient support programs and described the occurrence of constipation in a female patient who received niraparib (Zejula) capsule (batch number 8720486, expiry date 31st March 2022) for malignant neoplasm of ovary.   On 2nd June 2020, the patient started Zejula (oral) 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced constipation and fatigue. The action taken with Zejula was unknown. On an unknown date, the outcome of the constipation was unknown and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the constipation and fatigue to be related to Zejula.  Additional details: Patient reported constipation and took her colonoscopy medicine for that, and would get a another prescription that was sugar based. Spouse stated that patient had a little bit of fatigue, but she was ok. This case was not associated with a product complaint.  Follow up information received from consumer via another company: Zejula Patient BRC Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 08 Jul 2020: The patient received niraparib (Zejula) capsule (batch number 9078981, expiry date 30th April 2022) for malignant neoplasm of ovary. On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced nausea. Zejula was continued with no change. On an unknown date, the outcome of the constipation and nausea were not recovered/not resolved. It was unknown if the reporter considered the nausea to be related to Zejula. It was reported that the patient continued to have nausea and constipation (previously reported).  Follow up information received from consumer via another company: Zejula Patient BRC Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 27 Jul 2020: This case was reported by a consumer via patient support programs and described the occurrence of constipation in a female patient who received niraparib (Zejula) capsule (batch number 8720486, expiry date 31st March 2022), (batch number 9722426, expiry date 31st October 2022) and (batch number 9078981, expiry date 30th April 2022) for malignant neoplasm of ovary. On 2nd June 2020, the patient started Zejula (oral) 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On 12th May 2020, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced rash, itching and tumor marker abnormal. Zejula was continued with no change. On an unknown date, the outcome of the constipation and nausea were not recovered/not resolved and the outcome of the fatigue was recovering/resolving and the outcome of the rash, itching and tumor marker abnormal were unknown. It was unknown if the reporter considered the rash, itching and tumor marker abnormal to be related to Zejula. Rash/itching on arms and chest, CA-125 "had been erratic"  Follow up information received from consumer via another company: Zejula Patient BRC Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 26 August 2020 This case was reported by a consumer via patient support programs and described the occurrence of constipation in a female patient who received niraparib (Zejula) capsule (batch number 8720486, expiry date 31st March 2022), (batch number 9078981, expiry date 30th April 2022) and (batch number 9722426, expiry date 31st October 2022) for malignant neoplasm of ovary. Co-suspect products included granisetron (Sancuso Patch) for product used for unknown indication. On 12th May 2020, the patient started Zejula (oral) 200 mg once daily (200 mg daily). On 2nd June 2020, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the patient started Sancuso Patch at an unknown dose and frequency. On an unknown date, an unknown time after starting Zejula, the patient experienced nausea, adverse drug reaction. The patient was treated with cannabis oil (Cbd Oil). Zejula was continued with no change. The action taken with Sancuso Patch was unknown. On an unknown date, the outcome of the constipation and nausea were Recovering/Resolving and the outcome of the fatigue was recovering/resolving and the outcome of the rash, pruritus, tumor marker abnormal and adverse drug reaction were unknown. It was unknown if the reporter considered the constipation, fatigue, nausea, rash, pruritus, tumor marker abnormal and adverse drug reaction to be related to Zejula. It was unknown if the reporter considered the adverse drug reaction to be related to Sancuso Patch. Improved nausea with addition of CBD oil." and "She had a reaction to the Sancuso patch and stopped using it.  Follow up information received from consumer (Spouse) on 28 Sep 2020 via another company: Zejula Patient BRC Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients: Event rash recoded to localized rash and pruritus recoded to localized itching. Patient who received niraparib (Zejula) capsule (batch number 1096840, expiry date November 2022) for malignant neoplasm of ovary. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the patient received Flu vaccine at an unknown dose and frequency. On an unknown date, an unknown time after receiving Zejula and Flu vaccine, the patient experienced adverse drug reaction and sickness. The action taken with Flu vaccine was unknown. Sancuso Patch was discontinued (Dechallenge was unknown). On an unknown date, the outcome of the localized rash, localized itching, adverse drug reaction and sickness were unknown. Spouse stated that patient had a flu shot and had a reaction. Stated that patient was sick for three days after the shot. Spouse stated that patient had gotten past her constipation concerns. Spouse stated that patient was had labs monthly, but were now had them done every three months and they were good. Educated spouse on manufacturer's recommendation for monthly labs. Spouse stated that follow up oncology visit was scheduled for NOV 2020. Spouse denied any elevations in patient's blood pressure. Patient's spouse denied ER (emergency room) visits/specialists/hospital visits/missed doses/recent CT (computerized tomography) Scans. It was unknown if the reporter considered the localized rash, localized itching,adverse drug reaction and sickness to be related to Zejula. It was unknown if the reporter considered the constipation, fatigue, nausea, localized rash, localized itching and tumor marker abnormal to be related to Flu vaccine. The reporter considered the adverse drug reaction and sickness to be possibly related to Flu vaccine. It was unknown if the reporter considered the localized rash, localized itching, adverse drug reaction and sickness to be related to Sancuso Patch.