Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Off label use, Platelet count decreased, Platelet transfusion, Product dose omission issue, Stomatitis
Clinical narrative: very low white blood cell counts/ WBC currently stable; low platelets; blood pressure has slightly elevated / elevation after start from normal range of 130 to 140/90 to 150/95 / Blood pressure 130/83 / high blood pressure with slight elevation; low back pain; Missed 1 dose / missed 2 doses due to patient went out/came home late night; Dose is off-label per MD; Mouth sores; Terrible cough; congestion for 5 days; This case was reported by a consumer via patient support programs and described the occurrence of sores mouth in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule (batch number 2057807, expiry date 31st May 2022) for ovarian cancer and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 29th September 2022, the patient received Shingles vaccine. On 13th April 2022, the patient started Zejula 100 mg 300 mg once daily (300 mg daily). In June 2022, the dose was changed to 100 mg once daily (100 mg daily). On 29th September 2022, the patient received PNEUMONIA VACCINE. In April 2022, not applicable after receiving Shingles vaccine and less than 3 months after starting Zejula, the patient experienced sores mouth. In June 2022, the patient experienced off label dosing. In August 2022, the patient experienced missed dose. On 29th September 2022, the patient experienced cough and nasal congestion. On 14th October 2022, the patient experienced low back pain. On an unknown date, the patient experienced white blood cell count low, platelets decreased and hypertension aggravated. The patient was treated with platelets, human blood (Platelet Transfusion), metoprolol and triamterene. The dose of Zejula was decreased (Dechallenge was unknown). In October 2022, the outcome of the cough and nasal congestion were recovered/resolved. On an unknown date, the outcome of the sores mouth was unknown and the outcome of the white blood cell count low and missed dose were recovered/resolved and the outcome of the platelets decreased, hypertension aggravated, low back pain and off label dosing were not recovered/not resolved.   It was unknown if the reporter considered the hypertension aggravated, cough, nasal congestion and low back pain to be related to Shingles vaccine and Zejula. The reporter considered the sores mouth to be possibly related to Zejula. It was unknown if the reporter considered the white blood cell count low and platelets decreased to be related to Zejula.     Additional Information: GSK Receipt Date: 05 May 2022 Reporter's Comments: This information was received from consumer: Zejula pateint BRC Brochure. Inbound call from patient was scheduled, when agent was informed that  the patient experienced mouth sores a side effect of the medication. Warm transfer to RN (agent). No other details was provided. The event did not include product complaint.  Follow-up information received on 07-JUL-2022. This follow-up was considered significant.  Reporter's Comments: This information was received from consumer via Zejula enhanced Nurse Calls. Patient reported in Apr2022 (exact date unknown) she started taking 300 mg daily and developed very low white blood cell counts and low platelets and needed a platelet transfusion and physician put Zejula on hold for one month, counts improved and physician told her to restart Zejula 100 mg daily Jun2022 (exact date unknown) - current and stated she was doing well at this time. Patient reported she had history of high blood pressure and blood pressure had slightly elevated after start of therapy. Unknown if physician was aware. Summary of Changes: rechallenge result, dosage regimen, outcome of event, event added.  Follow-up information received on 10-AUG-2022. This follow-up was considered significant Reporter's Comments: This information was received from Consumer via Zejula enhanced Nurse Calls. As previously reported patient continued on Zejula 100mg daily (differs from script) since Jun2022 (exact date unknown) per physician direction. Patient reported pre-existing/history of elevated blood pressure. Patient reported elevation after start from normal range of 130 to 140/90 to 150/95 last week. Missed 1 dose of Zejula last week related to change in schedule with no adverse effects from missed dose. Physician was unaware. No additional information, details were provided by the patient. Summary of Changes: Lab data, event added.  Follow-up information received on 19-Sep-2022. This follow-up was considered significant.  Reporter's Comments: Patient reported since after start of therapy recently missed 2 doses due to patient went out/came home late night, MD aware. Patient reported since after start of therapy continue to take Zejula 100 mg daily since June 2022 (dose was off-label per MD) due to low White Blood cell count which was currently stable, reported current Blood pressure 130/83, patient took Metoprolol and Triamterene per MD. No further information/side effects provided. Summary of Changes: New event was added, events verbatim were updated, lab data added, treatment drugs were added and narrative updated.   Follow-up information received on 21-OCT-2022.  Reporter's comments: The reporter stated that the patient continued on Zejula 100mg daily since June 2022 as per MD. The reporter reported that the patient received shingles and Pneumonia vaccines. The reporter stated that less than a day after received Shingles and Pneumonia vaccine for 5 days the patient experienced terrible cough and congestion. On 14th October 2022 15 days after received Shingles and Pneumonia vaccine the patient experienced low back pain. patient had history of high blood pressure was slight elevated, after received Shingles and Pneumonia vaccine. It was unknown if the reporter considered the hypertension aggravated, cough, nasal congestion and low back pain to be related to Pneumonia vaccine. No additional information or details was provided by the patient. Summary of Changes: Suspected product details, events and narrative updated.