Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: falling asleep; palmar-plantar erythodysethesia; developed a skin condition; having problems with her memory; "things are a little off" with her labs; CA-125 went up; has blood work done quarterly; may have missed up to 2 or 3 doses" due to falling asleep / missed "one dose" because she forgot and fell asleep; went to the ER in January for abdominal pain; Pustulosis palmaris et plantaris; palms of her hands with pain; This case was reported by a consumer via regulatory authority and described the occurrence of sleepiness in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included atopic dermatitis (Broken out in atopic dermatitis, this was an issue prior to taking Zejula).   On 24th August 2019, the patient started Zejula (unknown) 100 mg once daily (100 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced sleepiness and missed dose. Zejula was continued with no change. On an unknown date, the outcome of the sleepiness and missed dose were unknown.   It was unknown if the reporter considered the sleepiness to be related to Zejula.  Additional information: Initial up information was reported on 05 January 2021 from consumer: Zejula Patient Fulfillment/Shipment; Zejula Nurse Calls To Patients. Patient takes Zejula as prescribed, may have missed up to 2 or 3 doses due to falling asleep. Suggested she try taking the medication an hour earlier or setting an alarm as a reminder. Labs are completed quarterly, last results fine. Patient reported she has broken out in atopic dermatitis. She stated it goes away for a while, then returns. This was an issue prior to taking Zejula, she doesn't think Zejula has affected it.  Follow up information was reported on 09 February 2021 from consumer via US Biologics: Zejula Shipment; Zejula Nurse Calls To Patients. Treatment drug includes clobetasol propionate. Patient reported taking Zejula 100 mg daily as prescribed by her doctor of medicine. Patient reported that she went to the emergency room in January for abdominal pain. Patient reported that all tests were negative and pain has resolved. Patient reported that her oncologist was aware of this. Patient reported that her oncologist referred her to a dermatologist who has prescribed clobetasol propionate for palmar-plantar erythodysethesia. Patient denied having any questions or concerns at this time. Adverse event: Patient reported that she went to the emergency room in January for abdominal pain. Patient reported that all tests were negative and pain has resolved. Patient reported that her oncologist referred her to a dermatologist who has prescribed clobetasol propionate for palmar-plantar erythodysethesia. On January 2021, the patient experienced abdominal pain. On an unknown date, the patient experienced palmar-plantar erythrodysaesthesia syndrome. On an unknown date, the outcome of the palmar-plantar erythrodysaesthesia syndrome was unknown and the outcome of the abdominal pain was recovered/resolved. It was unknown if the reporter considered the abdominal pain and palmar-plantar erythrodysaesthesia syndrome to be related to niraparib.  Follow up information received from consumer: Zejula Patient on 08 Mar 2021: Patient received niraparib (Zejula) capsule (batch number 1196788, expiry date January 2023). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the patient experienced error in performing labeled medication monitoring. Zejula was continued with no change. On an unknown date, the outcome of the error in performing labeled medication monitoring were unknown. Patient stated her next appointment with the oncologist was pending, she was waiting for a call. Patient stated she had blood work done quarterly. Discussed manufacturers recontamination for monthly blood work and she stated her provider was aware. This case was linked with case US2020AMR070603 and 2019-TSO03044-US due to same patient.  Follow up information received from consumer: Zejula Patient on 14 Apr 2021: The patient received niraparib (Zejula) capsule (batch number 1397375, expiry date 30th April 2023) for malignant neoplasm of fallopian tube. On 19th August 2019, the patient started Zejula (oral) 100 mg once daily (100 mg daily). On 24th August 2019, the dose was changed to 100 mg once daily (100 mg daily). In October 2020, an unknown time after starting Zejula, the patient experienced palmoplantar pustulosis and pain. The patient was treated with steroids nos (Steroids) and urea (Aquaphor Cream (Urea)). Zejula was continued with no change. On an unknown date, the outcome of the palmoplantar pustulosis and pain were unknown. It was unknown if the reporter considered the palmoplantar pustulosis and pain to be related to Zejula. The patient continued to take Zejula 100 mg QPM (every night) and denied missing a dose. She stated having recent lab work in March 2021 with good results and stated her blood pressure was good. The patient denied recent ER (emergency room) visits, hospitalizations, specialist visits, CT (computerized tomography) scans and EKG's, denied new drug allergies or new medications. The patient had pustulosis palmaris et plantaris since Oct 2020 in the palms of her hands with pain and was being treat with steroid creams and Aquaphor cream by her dermatologist.  Follow up information received from consumer: Zejula Patient on 19 May 2021: The patient received niraparib (Zejula) capsule (batch number 1845612, expiry date 31st January 2024) 100 mg once daily (100 mg daily) for malignant neoplasm of fallopian tube. On an unknown date, the patient experienced skin disorder. On an unknown date, the outcome of the skin disorder was unknown.It was unknown if the reporter considered the skin disorder to be related to Zejula.Patient stated that she had developed a skin condition.  Follow up information was received from consumer: Zejula on 22 Jun 2021. Concomitant products included Otezela. The female patient received niraparib (Zejula) capsule (batch number 1845610, expiry date 30th November 2023) for malignant neoplasm of fallopian tube at dose of 100 mg once daily. The patient took dose of niraparib to 100 mg once daily (100 mg daily).The action taken with Zejula was unknown. Patient reported that she was taking Otezela. Patient reported that she had also been prescribed Eucrisa topical ointment.  Follow up information was received from consumer: Zejula Patient on 22 Jul 2021: Patient received niraparib (Zejula) capsule (batch number 1845612, expiry date 31st January 2024). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the patient experienced lab test abnormal. Zejula was continued with no change. On an unknown date, the outcome of the lab test abnormal were unknown. It was unknown if the reporter considered the lab test abnormal to be related to Zejula. Patient reported that she continued to take her prescribed Zejula and denied missing any doses. Patient stated that things were a little off with her labs but does not give specifics. Patient stated that she was going on vacation and would like to had her medication prior to her leaving. Patient was informed that a fax request had been sent to her MD (doctor of medicine) and suggested that she follow up with her MD (doctor of medicine) for the new prescription to ensure there were no delays in her delivery prior to her vacation. No further issues or concerns reported. Diagnostic results): On an unknown date, Laboratory test result was little off.  Follow up information was received from consumer: Zejula Patient on 01 Dec 2021: On an unknown date, the dose was changed to 100 mg once daily (batch number 2054130, expiry date 31st March 2024) for malignant neoplasm of fallopian tube. On an unknown date, the patient experienced memory disturbance. On an unknown date, the outcome of the memory disturbance was unknown. It was unknown if the reporter considered the memory disturbance to be related to Zejula. Patient reported that she had missed one dose because she forgot and fell asleep. Patient reported that she was having problems with her memory and stated that she was not sure if it was from Zejula or the other chemo treatments she had had. Patient was informed that Cognitive dysfunction (including memory impairment) was a known side effect of Zejula (lexicomp). Patient reported that she was scheduled for both labs and a computed tomography scan on Friday and follow up physician appointment was scheduled for 20 Dec 2021. No further issues or concerns reported. Patient denied emergency room visits, hospitalizations, labs, scans, electrocardiogram, new medication or new drug allergies. (No additional information obtained).   Follow up information received from consumer on 20th January 2022: The patient self-reported this case. On an unknown date, the Zejula dose was changed to 100 mg once daily via oral route (batch number 2054131, expiry date 31st March 2024) for malignant neoplasm of fallopian tube.  The patient stated that she recently had the Shingles vaccine and experienced sleepiness, abdominal pain, palmoplantar pustulosis, palmar-plantar erythrodysesthesia syndrome, pain, skin disorder, lab test abnormal, memory disturbance and CA 125 (Carbohydrate antigen) increased. The patient reported that her CA-125 (Carbohydrate antigen) went up. The patient scan in December 2021 was clean.  Between 1 and 2 years after receiving 1st dose of Zejula, the patient experienced palmoplantar pustulosis, pain and abdominal pain. Less than 2 years after receiving 1st dose of Zejula, the patient experienced sleepiness, palmar-plantar erythrodysesthesia syndrome, skin disorder and lab test abnormal and more than 2 years after receiving 1st dose of Zejula, the patient experienced memory disturbance and CA 125 increased. It was unknown if the reporter considered the sleepiness, abdominal pain, palmoplantar pustulosis, palmar-plantar erythrodysesthesia syndrome, pain, skin disorder, lab test abnormal, memory disturbance and CA 125 (Carbohydrate antigen) increased to be related to Shingles vaccine. The patient did not consent to contact her health care provider. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-2019-TSO03044-US:same patient US-GLAXOSMITHKLINE-US2020AMR070603:same patient