Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anticoagulant therapy, Asthenia, Constipation, Diarrhoea, Drug dechallenge positive
Clinical narrative: low PLT; itchy bumps on feet/fingers; dry mouth; sunburn on feet; saw petechiae next morning; skipped one dose; Nausea; Headache; Fatigue; Weakness; Sleep disturbance; Constipation; This serious case was reported by a consumer via program and described the occurrence of platelets decreased in a 50-year-old female patient who received niraparib capsule (batch number 2700822, expiry date 31-JUL-2024) for ovarian cancer.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included apixaban (Eliquis), calcium, tocopherol (Vit E) and paracetamol (Tylenol).   On 10-APR-2023, the patient started niraparib (oral) 300 mg daily (300 mg daily) and Shingles vaccine. In APR-2023, less than a month after starting niraparib and an unknown time after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue), weakness (Verbatim: Weakness), sleep disturbance (Verbatim: Sleep disturbance) and constipation (Verbatim: Constipation). On 02-MAY-2023, the patient experienced platelets decreased (Verbatim: low PLT) (serious criteria hospitalization). On an unknown date, the patient experienced itchy rash (Verbatim: itchy bumps on feet/fingers), dry mouth (Verbatim: dry mouth), sunburn (Verbatim: sunburn on feet), petechia (Verbatim: saw petechiae next morning) and missed dose (Verbatim: skipped one dose). The subject was treated with antiemetics and antinauseants (Nausea Medication (Nos)), olanzapine, olanzapine (Zyprexa) and medication unknown (Transfusion). Niraparib was interrupted (Dechallenge was positive). The outcome of the platelets decreased was not resolved and the outcome of the nausea, headache, fatigue, weakness, sleep disturbance, constipation, itchy rash, dry mouth, sunburn and petechia were resolving and the outcome of the missed dose was unknown.   It was unknown if the reporter considered the platelets decreased, nausea, headache, fatigue, weakness, sleep disturbance, constipation, itchy rash, dry mouth, sunburn and petechia to be related to niraparib and Shingles vaccine.     The company considered the platelets decreased to be unrelated to niraparib. It was unknown if the company considered the nausea, headache, fatigue, weakness, sleep disturbance, constipation, itchy rash, dry mouth, sunburn and petechia to be related to niraparib and Shingles vaccine. It was unknown if the company considered the platelets decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 14 Apr 2023 This information was received from consumer via  Pharmacy. Patient received niraparib was zejula. Adverse event: slight nausea, slight headache, fatigue, weakness noted, sleep disturbance, constipation Concomitant Medications: Eliquis, stool softener, Calcium, vit D, vit E, anti-nausea meds, tylenol PRN. Start Date 10 April 2023 on 300mg for Ovarian cancer. concomitant medication included stool softener, vitamin D.  Follow-up information received on 21-APR-2023.  This information was received from consumer via Pharmacy. Adverse event: New: shingles vaccine received same day as day she started Zejula, some itchy bumps on feet/fingers (better now) dry mouth, skipped one dose to change to AM dosing Follow up: slight nausea (better), slight headache (better), fatigue (better), weakness noted (better), sleep disturbance (better), constipation (same). Summary of changes: co-suspect, event added, outcome of event, treatment drug.  Follow-up information received on 05-MAY-2023.  This information was received from consumer via Pharmacy. After 3-point authentication of full name, DOB, and address, spoke with patient on 05 May 2023 at 12:15 with regards to Zejula for nursing assessment. Therapy was on hold due to low platelet. Missed doses: none other than prescribed. Activity level :  fatigue, weakness, headache better since Zejula on hold. Appetite: good, Hydration status: good. Nausea/vomiting/mucositis/taste changes/weight loss: nausea better since taking Zyprexa. Dry mouth constipation better since Zejula on hold. Diarrhea/constipation: constipation better since Zejula on hold. Skin issues: sunburn on feet, saw petechiae next morning where she had sunburn that was resolving now. Sleep changes: better since Zejula on hold. Blood pressure/heart rate: holding steady, unchanged since start of Zejula. Last lab: 02 May 2023. Results were platelet critically low, got transfusion. Labs on 04 May 2023 still low, but in an acceptable level. Next lab: this afternoon and Monday morning. Next oncologist appointment: maybe next week. New scans/imaging: no. New EKG (electrocardiogram): no. Specialist visits: no. Emergency room/urgent care visit, hospital admissions: Hospitalized for 2 days because of low platelet. MD (physician) instructed her to go to hospital, direct admission. RX Update: No new medications or new drug allergies. Refill: No refill required at this time. Summary of Changes: Laboratory data added, suspect product stop date added, treatment drug added, new event added, event outcome updated, narrative updated.; Sender's Comments: platelets count decreased is a listed event which is considered related to GSK drug niraparib .