Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Platelet count decreased, Product dose omission issue, Thrombocytopenia, Tooth disorder, White blood cell count
Clinical narrative: Thrombocytopenia; tummy queasiness/pt states "queasiness has gone away"; loss of appetite/Pt states "her appetite is back"; she has a bitterness in the back of her tongue with certain foods; blood pressure (BP) has been high/ BP little high/BP runs little high/still normal than prior to start with systolic 126 to 130 over/slight elevation with BP (last reading 2 weeks ago 140 over 77); platelets are down a little bit/platelets were real low/Platelets dropped again/ platelets "tanked"; bruises easier; blood pressure is a little elevated/ continues slight elevation with BP (last reading 2 weeks ago 140 over 77)/elevated blood pressure 120 to 130 over 80 range. / Blood pressure remains stable; takes a little longer for her to fall asleep; one of teeth "was weakened"; Alkaline Phosphatase was above normal; sun sensitivity skin turns red or gets darker; low white blood cell count; admits to missing one dose due to delayed shipment; chills; sweating; aches; This case was reported by a consumer via patient support programs and described the occurrence of thrombocytopenia in a 58-year-old female patient who received Flu unspecified (Flu vaccine) for flu prevention.   Co-suspect products included niraparib (Zejula) capsule (batch number 9722430, expiry date October 2022), (batch number 9266890, expiry date 30th September 2022), (batch number 1196788, expiry date January 2023), (batch number 1359483, expiry date January 2023), (batch number 1845612, expiry date 31st January 2024) and (batch number 1844082, expiry date 31st August 2024) for ovarian cancer and covid-19 vaccine (Covid 19 Vaccine Booster) for covid-19 prophylaxis.   Concomitant products included covid-19 vaccine (Covid-19 Booster) and influenza vaccine (Flu Vaccine (Name Unknown)).   On 24th September 2022, the patient received Flu vaccine. On 11th September 2020, the patient started Zejula 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). On 24th September 2022, the patient started Covid 19 Vaccine Booster at an unknown dose and frequency. On 24th September 2022, an unknown time after receiving Flu vaccine and 2 years 13 days after starting Zejula, the patient experienced pain, chills and sweating. On an unknown date, the patient experienced thrombocytopenia (serious criteria GSK medically significant), queasy, appetite lost, taste bitter, blood pressure high, platelet count decreased, contusion, increased blood pressure, trouble falling asleep, tooth disorder, blood alkaline phosphatase increased, photosensitivity erythema, white blood cell count decreased and missed dose. The patient was treated with lisinopril. Zejula was interrupted (Dechallenge was positive). Rechallenge with Zejula was unknown. On an unknown date, the outcome of the thrombocytopenia, queasy, appetite lost, blood pressure high, platelet count decreased, increased blood pressure, photosensitivity erythema, pain, chills and sweating were recovered/resolved and the outcome of the taste bitter, trouble falling asleep, tooth disorder, blood alkaline phosphatase increased and missed dose were unknown and the outcome of the contusion and white blood cell count decreased were not recovered/not resolved.   It was unknown if the reporter considered the thrombocytopenia, queasy, appetite lost, taste bitter, blood pressure high, platelet count decreased, contusion, increased blood pressure, trouble falling asleep, tooth disorder, blood alkaline phosphatase increased, photosensitivity erythema, white blood cell count decreased, pain, chills and sweating to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 17 SEP 2020. Reporter's Comments: This case was reported by a consumer via follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients. Patient stated that she takes her prescribed 200mg of Zejula in the PM with food. Patient complains of tummy queasiness and loss of appetite. Suggested to patient to try to eat small meals throughout the day as well as drinking at least 6 to 8 glasses of water/day. Patient stated that she did not have labs scheduled until 29 Sep 2020. Educated patient on manufacturer's recommendation for weekly labs for first four weeks, then monthly thereafter. Patient stated that follow up oncology appointment was scheduled for 01 Oct 2020. Patient denies emergency room (ER) visits or specialists or hospital visits or missed doses.  Follow up report received from consumer on 25 Sep 2020: Reporter's Comments: Patient stated that she took her prescribed Zejula in the PM without food. Patient stated that she felt much better this week. Stated that the first week she had queasiness to her stomach, but that had gone away. Stated that she ate crackers to help with the queasiness. Patient stated that her appetite was back. Patient stated that she had a bitterness in the back of her tongue with certain foods. Patient denied sores in her mouth. Patient stated that labs were done weekly, and follow up oncology visit was scheduled for 01 OCT 2020. Patient stated that she monitored her blood pressure three times a day and it had been high. Stated that she kept a record of her blood pressure and she would show her MD at next visit. Patient denied ER visits/specialists/hospital visits/recent CT scans/missed doses. Event reported: she felt much better this week, the first week she had queasiness to her stomach, but that had gone away, appetite was back, had a bitterness in the back of her tongue with certain foods, blood pressure had been high.   Follow up information received from consumer via follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 07 Oct 2020: Reporter's Comments: The patient took her prescribed Zejula in the PM (evening) without food. Patient denied having side effects from the Zejula. Patient stated that everything was going well and she was sleeping well. The patient stated that her labs were now being done monthly, and they look pretty good, everything was on track, but platelets were down a little bit. The patient stated that her oncologist was not too concerned. The patient stated that she had noticed she bruises easier the last couple of days. Informed patient that bruising was related to low platelet count and to notify her MD. The patient stated that her follow up oncology visit was scheduled for 05 Nov 2020. The patient stated that her blood pressure was a little elevated 130's/80's-90's. The patient stated that her MD was aware and was advised to continue to monitor by her MD. Patient denied ER (emergency room) visits or specialists or hospital visit or missed doses or recent scans.  Follow up information received from consumer via Follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 01 Dec 2020: Reporter's Comments: Decreased her Zejula to 100mg once a day because her platelets were real low, she stopped the Zejula for two weeks, her platelets went back up to 400, and two weeks later her Platelets dropped again so her doctor of medicine (MD) wanted her to stay on the 100mg dose.   Follow up information received from consumer via Follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 03 Feb 2021: Reporter's Comments: Denies going to emergency room (ER), admittance to hospital, electrocardiogram (EKG), computed tomography (CT) scan, magnetic resonance imaging (MRI), seeing specialist other than oncologist, new medications, new allergies, emotions affecting daily activities, nor side effects. Patient demographic was updated (age).  Follow up information received from consumer via Follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 31 Mar 2021: Reporter's Comments: Spoke with patient. Patient had labs done on Monday and will see her oncologist today. She reported her last computerized tomogram (CT) scan in December was clear and she will have a breast magnetic resonance imaging (MRI) done in April. Patient stated it took a little longer for her to fall asleep and then she slept in a little later but stated it was not true insomnia.  Follow up information received from consumer via Follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 13 Jul 2021:  Reporter's Comments: She stated that her dentist said one of her teeth was weakened.  Follow up information received from consumer via Follow-up: Patient Fulfillment/Shipment; Nurse Calls To Patients on 26 August 2021: Reporter's Comments: Labs were done on 16 AUG 2021, all were good except the Alkaline Phosphatase was above normal for the first time in patient life, 135. would have labs rechecked in 3 weeks.  Follow up information was received from consumer via Enhanced Nurse Calls on 11 Oct 2021. Reporter's Comments: Patient reported after start of therapy (200 mg) platelets tanked (value unknown). Zejula stopped (date unknown) for 1 to 2 weeks and restarted at 100 mg the end of September/first of October 2020. Since restarted Zejula lab values have remained stable (values unknown). Lab in September 2021 indicated normal CA 125(Cancer Antigen) at 6.8. Blood Pressure runs little high/still normal than prior to start with systolic 126 to 130 over diastolic 80 to 85 range (no medication). Per patient in remission. MD (physician) was aware. No further information/details were disclosed.  Follow up information was received from consumer via Enhanced Nurse Calls on 16 Nov 2021. Reporter's Comments: Patient reported after start of therapy and continued slight elevation with Blood pressure (last reading 2 weeks ago 140 over 77), lab results 2 weeks ago normal (date and values unknown). Stated doing very well. MD (physician) was aware. Patient shared she received the Coronavirus booster and flu vaccine on 14 Nov 2021. Reported no side effects/adverse effects from vaccines. Unknown if MD (physician) was aware patient received vaccines. No additional information/specific details were provided by the patient.  Follow up information was received from consumer via Enhanced Nurse Calls on 21 Feb 2022: Reporter's Comments: Patient reported after start of therapy and continues elevated blood pressure 120 to 130 over 80 range. Doctor aware. No additional information/specific details were provided by the patient.  Follow up information was received from consumer via Enhanced Nurse Calls on 23 Mar 2022: Reporter's Comments: Patient reported after start since last contact 21 February 2022 blood pressure remained elevated. MD (Physician)prescribed Lisinopril 20 mg daily on 24 February 2022. Stated blood pressure returned to normal range (no readings provided). No additional information/specific details or dates were provided by the patient.  Follow-up information received on 26-MAY-2022. This follow-up was considered significant. Reporter's Comments: This case was reported by a consumer via Enhanced Nurse Calls. Patient reported after start continued on Lisinopril for elevated blood pressure (previously reported). Blood pressure remained stable. Completed routine Computerized Tomography (CT) scan 20 May 2022 with no new growth. No additional information, specific details were provided by the patient. Summary of changes: Lab data updated.  Follow-up information received on 30-JUN-2022. This follow-up was considered significant. Reporter's Comments: This case was reported by consumer via Enhanced Nurse Calls. Patient reported after start sun sensitivity (skin turns red or gets darker) when outdoors, resolved indoors. Blood pressure remained stable on Lisinopril. Lab results that month were good/cancer marker stable. No additional information, specific details or dates were provided by the patient. Summary of changes: Lab data updated, Event added.  Follow-up information received on 26-AUG-2022. This follow-up was considered significant. Reporter's Comments: This case reported by consumer via Enhanced Nurse Calls. Patient reported after start, ongoing low white blood cell count but within normal limits (value unknown) and blood pressure remained stable with Lisinopril. No additional information, details were provided by the patient. Summary of changes: New event added, lab result added.  Follow-up information received on 28-SEP-2022. This follow-up was considered significant. Reporter's Comments: This case reported by consumer via Enhanced Nurse Calls. Patient reported receiving both flu vaccine and COVID booster vaccines 24 September 2022 with aches, chills, sweating for 48 hours after vaccines. Symptoms resolved, no further issues. No additional information or details were provided by the patient. It was unknown if the reporter considered the thrombocytopenia, queasy, appetite lost, taste bitter, blood pressure high, platelet count decreased, contusion, increased blood pressure, trouble falling asleep, tooth disorder, blood alkaline phosphatase increased, photosensitivity erythema, white blood cell count decreased, pain, chills and sweating to be related to Covid-19 Vaccine Booster. Summary of changes: Co-suspect products added, new event added.