Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Carbohydrate antigen 125, Condition aggravated, Decreased activity, Dry skin, Fatigue
Clinical narrative: pyoderma gangrenous; had shingles 3 times, had both Shingrix shots/suspected vaccination failure; mild case of Shingles/Shingles infection has cleared up/fighting on/off shingles / had shingles 3 times; Spends less than 50% of day sitting or laying down; dry patch of skin over eye; few bumps on left cheek; physician prescribed maintenance Valacyclovir for prevention of recurrences; increased fatigue / increased fatigue since starting the Zejula unchanged; decreased platelets/platelets 297,000/low platelet; This case was reported by a consumer via patient support programs and described the occurrence of pyoderma gangrenous in a 74-year-old female patient who received niraparib (Zejula) capsule (batch number 2054129, expiry date 31st March 2024), (batch number 2054130, expiry date 31st March 2024), (batch number 2054131, expiry date 31st March 2024), (batch number 2057802, expiry date 30th April 2024), (batch number 2057805, expiry date 30th April 2024), (batch number 2057809, expiry date 30th April 2024), (batch number 2057807, expiry date 31st May 2024) and (batch number 2057808, expiry date 30th June 2024) for malignant neoplasm of ovary.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for shingles, Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chemo with an associated reaction of ulcer. Concurrent medical conditions included ulcer (improved with continued healing), ankle injury and foot ulcer (almost healed). Concomitant products included dofetilide, metoprolol, lisinopril, colecalciferol (Vit D3), metoprolol tartrate, ascorbic acid (Vitamin C) and acetylsalicylic acid (Aspirin).   On 4th August 2021, the patient started Zejula 300 mg once daily (300 mg daily). On 26th August 2021, 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 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 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 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 Valacyclovir 1000 mg once daily (1000 mg daily), the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2021, an unknown time after starting Zejula and Valacyclovir and unknown after receiving Shingrix and Shingrix, the patient experienced fatigue aggravated and platelets decreased. On an unknown date, the patient experienced pyoderma gangrenous (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles, decreased activity, dry skin, rash and off label use in unapproved indication. The patient was treated with doxycycline, white soft paraffin (Vaseline) and valaciclovir hydrochloride (Valtrex). The dose of Zejula was decreased (Dechallenge was unknown). The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the pyoderma gangrenous, vaccination failure, rash and off label use in unapproved indication were unknown and the outcome of the fatigue aggravated was recovering/resolving and the outcome of the platelets decreased and dry skin were recovered/resolved and the outcome of the shingles and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the pyoderma gangrenous, fatigue aggravated, platelets decreased, shingles, decreased activity, dry skin, rash and off label use in unapproved indication to be related to Zejula. The reporter considered the vaccination failure to be unrelated to Zejula and Valacyclovir. It was unknown if the reporter considered the pyoderma gangrenous, fatigue aggravated, platelets decreased, shingles, decreased activity, dry skin and rash to be related to Valacyclovir. The reporter considered the pyoderma gangrenous, fatigue aggravated, platelets decreased and decreased activity to be unrelated to Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, dry skin and rash to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR086424   Additional Information: GSK Receipt Date: 16 Aug 2021. Reporters comment: Patient had experienced increased fatigue since starting the Zejula, she had a preexisting injury from 10 years ago when a vein in her R ankle/foot was damaged and she had never been right and while on IV chemo an ulcer formed. she had been seeing a wound care specialist since then, she was  now seen them q2 weeks and she stated that ulceration does seem to be improved and healing, it was painful and bothersome for her last lab was 11 Aug 2021 within normal limit Next lab 18 Aug 2021 .  Follow up information was received from consumer on 27 Aug 2021 via Zejula PAP Together with Pharmacy: Reporters comment: Patient had experienced increased fatigue since starting the Zejula unchanged, pre-existing right foot/ankle ulcer and was seeing a wound care specialist for 2 weeks and had improved with continued healing. Last lab 18 Aug 2021 decreased platelets but patient could not provide value. Next lab 01 Sep 2021 and physician (MD). Start date 04 Aug 2021 at 300 mg Ovarian 26 Aug 2021- dose decreased to 200 mg- decreased platelets. Event fatigue was recoded with fatigue aggravated.  Follow up information was received from consumer on 27 Sep 2021 via Zejula PAP Together with Pharmacy: Reporters comment: Platelets 297,000. Start date 04 Aug 2021 at 300mg Ovarian. 26 Aug 2021-dose decreased to 200 mg- decreased platelets.  Follow up information was received from consumer on 04 Oct 2021 via Zejula PAP Together with Pharmacy: Reporters comment: Patient stated she has a mild case of Shingles and would be on valacyclovir till 08 Oct 21.   Follow up information was received from consumer on 27 Oct 2021 via Zejula PAP Together with Pharmacy: Reporters comment: Drug Zejula start date 04 Aug 2021 at 300 mg Ovarian, 26 Aug 2021 dose decreased to 200 mg due to decreased platelets. Dose was 200 mg at 9:30 PM (night) with food. Notes Spoke with patient today, 27 Oct 2021. Verified drug and dose. Missed doses as none. Activity level as fatigue was getting better. Spent less than 50% of day sitting or laid down. Appetite was good. Hydration status as good. Nausea, vomiting as none. Diarrhea, constipation as none. Skin issues as dry patch of skin over eye and put Vaseline on it. Previously reported preexisting right foot, ankle ulcer had now been diagnosed as pyoderma gangrenous and now taking doxycycline. Shingles infection had cleared up. Sleep changes as denied, sleeping was pretty good. Blood pressure, heart rate as 126/70 at HCP (Healthcare professional) today. Both had been good, 112/69 and 74 yesterdays. Last lab was on Monday. Results reported as good. Next lab would in a month. Next oncologist appointment on Friday. No new scan, EKG (electrocardiogram), specialist visits, emergency room, urgent care visit, hospital admissions. No new drug allergies. Medication list reviewed and updated. No DDI (drug drug interaction) found. No refill required at this time. New as dry patch of skin over eye and put Vaseline on it. Follow up Previously reported preexisting right foot, ankle ulcer had now been diagnosed as pyoderma gangrenous and now taking doxycycline. Shingles infection had cleared up; fatigue. Resolved as decreased platelets.  Follow up information was received from consumer on 24 Nov 2021 via Zejula PAP Together with Pharmacy: Reporters comment: Ulcers on legs that were healing. Start date 04 Aug 2021 at 300 mg Ovarian, 26 Aug 2021 dose decreased to 200 mg due to decreased platelets.  Follow up information was received from consumer on 24 Jan 2022 via Zejula PAP Together with Pharmacy: Reporters comment: Concomitant products included dofetilide, metoprolol, lisinopril, vitamins nos (Multivitamin), colecalciferol (Vit D3) and caltrate (nos) (Caltrate). Zejula C6D23; start date 04 Aug 2021 at 300 mg Ovarian. 26 Aug 2021 - dose decreased to 200 mg - low platelets. Dose: 200 mg 9:30 PM without food. Verified current dose 200 mg. Adverse Events: previously reported ulcers on legs much improved and still healing. Last lab Dec 2021 WNL (within normal limits). Next lab 26 Jan 2022, Doctor's appointmen next 31 Jan 2022. Appetite good, hydration good, blood pressure stable/controlled, sleeping well. No diarrhea/constipation/nausea/skin issues. Concomitant medications reviewed with patient: Dofetilide, Metoprolol, Lisinopril, Multivitamin, Vit D3, Caltrate 600. No EKG (electrocardiogram), scan, specialist visit, ER (emergency room) visit, hospital admission, no new drug allergies or medications, no refill needed, no missed doses.  Follow up information was received from consumer via Zejula PAP Together with Pharmacy on 25 Feb 2022: Reporters comment: Zejula start date 04 Aug 2021 at 300 mg Ovarian, 26 Aug 2021 dose decreased to 200 mg low platelets. Dose 200 mg 9:30 PM (night) without food. Called to patient for nurse assessment and 3 identifiers obtained, and verified current dose 200 mg. Adverse Events previously reported ulcers on legs much improved and still healing continued. Last lab 31 Jan 2022 WNL (within normal limit) and saw MD (physician). Next lab and MD 04 May 2022. Confirmed appetite good, hydration good, blood pressure stable/controlled, sleeping well. Denied diarrhea, constipation, nausea, skin issues. No EKG (electrocardiogram), scan, specialist visit, ER (emergency room) visit, hospital admission, no new drug allergies or medications, no refill needed, no missed doses.  Follow-up information received on 31-MAR-2022. This follow-up was considered significant.  Reporters comment: This information was received from consumer via Zejula PAP Together with Pharmacy. New shingles infection. Follow-up included previously reported pre-existed right foot/ankle ulcer healed really good finally. Fatigue energy level came back. Resolved decreased platelets.  Summary of changes: Current condition updated, concomitant products, event outcome detail updated.  Follow-up information received on 26-APR-2022. This follow-up was considered significant.  Reporters comment: This case was received from consumer via Zejula PAP Together with Pharmacy. Spoke with patient today, 26 Apr 2022. Patient identity verified with three patient identifiers. Verified drug and dose. No missed dose. Activity level: Spent less than 50 percent of day sat or laid down. Appetite was good. Hydration status was good. Nausea/vomiting was none. Diarrhea/constipation was none. Skin issues was previously reported preexisting right foot/ankle ulcer was almost healed. She stopped. Not gone to wound clinic. Sleep changes was denied. Blood pressure/heart rate was good. Shingles infection had resolved. Last lab was none since last call. Results was n/a. Next lab on 02 May 2022. Next oncologist appointment: 04 May 2022. No new scan, EKG (electrocardiogram), specialist visits, emergency room/urgent care visit, hospital admissions. No new medications or new drug allergies. New was none. Summary of changes: Pregnancy detail, Lab Data, Product detail, Event outcome updated.  Follow-up information received on 24 May 2022. This follow-up was considered significant.  Reporters comment: Zejula start date was 04Aug2021 at 300 mg for Ovarian cancer, on 26 Aug 2021 dose was decreased to 200 mg for low platelets. Spoke with patient on 24May2022 at 10:35 with regards to Zejula for nursing assessment. Patient returned call for nursing assessment. Returned patient's call. Verified drug and dose. Missed doses were none. Activity level: occasional mild fatigue was improved. Appetite was good. Hydration status was good. Nausea, vomiting, mucositis, taste changes and weight loss: none. Diarrhea and constipation: none. Skin issues: fighting on/off shingles. She did not had shingles infection currently but started taking Valtrex prophylactically. Previously reported preexisting right foot/ankle ulcer was almost healed completely. Not going to wound clinic. Sleep changes was denied. Blood pressure/heart rate was good. Last lab was on 02 May 2022, Results: reported as good. CA 125 (carbohydrate antigen 125) count was 6.4. Next lab on 04 Aug 2022. Next oncologist appointment on 08 Aug 2022. New scans/imaging was reported as: no. New EKG (electrocardiography) was reported as: no. Specialist visits: no. Emergency room/urgent care visit, hospital admissions: no. RX (prescription) Update: No new medications or new drug allergies. New events were reported: fighting on/off shingles. She does not have shingles infection currently but started taking Valtrex prophylactically. CA125 was 6.4. Follow-up: Previously reported preexisting right foot/ankle ulcer was almost healed; fatigue. Resolved events included: decreased platelets, shingles infection. Summary of Changes: New dosage regimen, event verbatim, lab data added. Event outcome updated.  Follow-up information received on 31 May 2022. This follow-up was considered significant.  Reporter's comment: Patient stated she has had shingles 3 times within the past 5 months with last episode on May 13, 2022. The shingles symptoms had not been severe. Her physician had prescribed her maintenance Valacyclovir 1000mg daily for prevention of recurrences. She stated she currently had a few bumps on her left cheek but it was not itchy, not red, not crusty. She has had both of her shingrix shots. Concomitant Medications: valacyclovir 1000mg, vitamin c, aspirin 81mg, dofetilide, metoprolol, lisinopril, multivitamin, vitamin d3, caltrate. Summary of changes: Co-suspect, treatment drug and event added.  Follow-up information received on 31-MAY-2022. This follow-up was considered significant Case update (Error correction):This report is being resubmitted to capture corrections. The information was received on 31-MAY-2022 and is as follows: suspect drug Shingrix was captured in the case along with event Vaccination failure was captured. Causality as updated with respect to events. Case US2022AMR086424 would be deleted from database as it was a duplicate case and merging process was performed. Case correction was performed to generate regulatory reports for Shingrix as concomitant Shingrix was deleted and considered as suspect. Summary of Changes: Outcome of event, event added, rechallenge results, dosage regimen, causality.