Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Immunodeficiency, Incisional hernia, Influenza like illness, Laboratory test abnormal, Myalgia
Clinical narrative: CHILLS; HEADACHES; MUSCLE ACHES; ALL OF MY NUMBERS WERE WONKY; Platelets had dropped to 75,000/ low platelets /had another episode when they were borderline low/Platelet drop substantially; WHITE BLOOD CELLS WERE DOWN; NEUTROPHILS WERE DOWN; liver enzymer were extremely high; mild thrombocytopenia; Immunocompromised; FLU LIKE SYMPTOMS; NAUSEA; VOMITING; DIASTOLIC NUMBER HAD BEEN HIGHER THAN BEFORE/ZEJULA IS ELEVATING MY BOTTOM NUMBER. IT HAS FROM THE BEGINNING; HAD NUMEROUS SIDE EFFECTS; high blood pressure/my blood pressure have been better; increased heart palpitation / palpitations/my and heart palpitations have been better; blood count dropped; Incisional hernia; RAPID HEARTBEAT; PNEUMONIA; FEVER/HIGH FEVER/MYSTERIOUS FEVER THAT LASTED ABOUT A WEEK; This serious case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a 60-year-old female patient who received niraparib (Zejula) capsule (batch number 2416866, expiry date 30-JUN-2024) for ovarian cancer.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis and ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   The patient's past medical history included total hysterectomy (History), post procedural pain, hypertension (primary), ovarian cancer and pneumonia. Concurrent medical conditions included drug allergy (Codeine in highschool/ Benadryl allergy) and drug allergy (Codein). Concomitant products included ondansetron, azelastine, melatonin, macrogol (Miralax), prochlorperazine maleate and prochlorperazine.   In DEC-2021, the patient started Zejula (oral) 100 mg 200 mg daily (200 mg daily). The dose was changed to 200 mg daily (200 mg daily). The dose was changed to 200 mg daily (200 mg daily). On an unknown date, the patient received Shingles vaccine and MODERNA COVID VACCINE. On 02-JUL-2022, the patient received MODERNA COVID VACCINE. In JAN-2022, an unknown time after starting Zejula and an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: FEVER/HIGH FEVER/MYSTERIOUS FEVER THAT LASTED ABOUT A WEEK). In AUG-2022, the patient experienced pneumonia (Verbatim: PNEUMONIA) (serious criteria GSK medically significant). On 02-SEP-2022, the patient experienced heartbeats increased (Verbatim: RAPID HEARTBEAT). On an unknown date, the patient experienced thrombocytopenia (Verbatim: mild thrombocytopenia) (serious criteria GSK medically significant), immunocompromised (Verbatim: Immunocompromised) (serious criteria GSK medically significant), influenza-like symptoms (Verbatim: FLU LIKE SYMPTOMS), nausea (Verbatim: NAUSEA), vomiting (Verbatim: VOMITING), chills (Verbatim: CHILLS), headache (Verbatim: HEADACHES), muscle pain (Verbatim: MUSCLE ACHES), lab test abnormal (Verbatim: ALL OF MY NUMBERS WERE WONKY), platelet count decreased (Verbatim: Platelets had dropped to 75,000/ low platelets /had another episode when they were borderline low/Platelet drop substantially), white blood cell count decreased (Verbatim: WHITE BLOOD CELLS WERE DOWN), neutrophil count decreased (Verbatim: NEUTROPHILS WERE DOWN), elevated liver enzymes (Verbatim: liver enzymer were extremely high), diastolic blood pressure increased (Verbatim: DIASTOLIC NUMBER HAD BEEN HIGHER THAN BEFORE/ZEJULA IS ELEVATING MY BOTTOM NUMBER. IT HAS FROM THE BEGINNING), adverse drug reaction (Verbatim: HAD NUMEROUS SIDE EFFECTS), increased blood pressure (Verbatim: high blood pressure/my blood pressure have been better), palpitations aggravated (Verbatim: increased heart palpitation / palpitations/my, heart palpitations have been better), full blood count decreased (Verbatim: blood count dropped) and incisional hernia (Verbatim: Incisional hernia), . The patient was treated with metoprolol succinate, metoprolol and medication unknown (Blood Pressure Medication). Zejula was interrupted. The outcome of the pneumonia, influenza-like symptoms, nausea, vomiting, chills, headache, muscle pain, lab test abnormal, white blood cell count decreased, neutrophil count decreased, heartbeats increased, diastolic blood pressure increased and adverse drug reaction were resolved and the outcome of the thrombocytopenia, increased blood pressure and palpitations aggravated were resolving and the outcome of the immunocompromised, full blood count decreased and incisional hernia were unknown and the outcome of the fever was resolved (duration 1 week) and the outcome of the platelet count decreased and elevated liver enzymes were not resolved.   It was unknown if the reporter considered the pneumonia, thrombocytopenia, immunocompromised, influenza-like symptoms, nausea, vomiting, fever, chills, headache, muscle pain, lab test abnormal, white blood cell count decreased, neutrophil count decreased, elevated liver enzymes, heartbeats increased, diastolic blood pressure increased, increased blood pressure, palpitations aggravated, full blood count decreased and incisional hernia to be related to Zejula and Shingles vaccine. The reporter considered the platelet count decreased and adverse drug reaction to be related to Zejula. It was unknown if the reporter considered the platelet count decreased and adverse drug reaction to be related to Shingles vaccine.     It was unknown if the company considered the pneumonia, thrombocytopenia, immunocompromised, influenza-like symptoms, nausea, vomiting, fever, chills, headache, muscle pain, lab test abnormal, white blood cell count decreased, neutrophil count decreased, elevated liver enzymes, heartbeats increased, diastolic blood pressure increased, increased blood pressure, palpitations aggravated, full blood count decreased and incisional hernia to be related to Zejula and Shingles vaccine. The company considered the platelet count decreased and adverse drug reaction to be related to Zejula. It was unknown if the company considered the platelet count decreased and adverse drug reaction to be related to Shingles vaccine.   GSK Receipt date: 13 Oct 2022 Reporter's comments: This information was received from nurse. Patient stated, each covid vaccine (brand: moderna) she had gotten flu like symptoms for a couple of days. The last time she got the second booster, july 2022 (02 Jul 2022), was the first time she took it while being on zejula, and she got much more of a reaction: nausea, vomiting, fever, chills, headaches, muscle aches. But she also had a blood test after that vaccine and all of her numbers were wonky, included her platelets had dropped to 75,000; her white blood cells were down; her neutrophils were down; and her liver enzymes were extremely high. Patient stated, She also had low platelets when she first started zejula, and she had another episode when they were borderline low when that turned out she had pneumonia recently. that was the very end of august (Aug 2022). She went into the emergency room on 02 Sep 2022 because of a high fever and rapid heartbeat. They gave her antibiotics through her port and sent her home with a prescription for 10 days. Patient stated, when she started the zejula her diastolic number had been higher than before, and when she started zejula, within the first week of january, she got a mysterious fever that lasted about a week. At that point she had numerous side effects from zejula. Patient stated, that was (zejula) got a horrible taste. Reported history: total hysterectomy (04 Jun 2021); hypersensitivity reaction to codeine in high school; pneumonia (Aug 2022). Medical doctor aware of all of the aforementioned. No known allergies. Medical history:  other acute post procedural pain, hypertension. Benadryl allergy. Concomitant products included miralax, melatonin, melatonin, prochlorperazine maleate, women's multivitamin, azelastine. Reporter considered the pneumonia, influenza-like symptoms, nausea, vomiting, fever, chills, headache, muscle pain, lab test abnormal, platelet count decreased, white blood cell count decreased, neutrophil count decreased, elevated liver enzymes, heartbeats increased and diastolic blood pressure increased to be related to covid vaccine.  Follow-up information received on 13-DEC-2022.  Reporter's Comments: This information was received from nurse via Adverse Event/Product Complaint Form. Patient reported the zejula was elevating her bottom number. It had from the beginning. and it continued to but not so much to do anything about it. per patient, her systolic number was fairly normal. Physician aware. Summary of Changes: other relevant history, dosage regimen.  Follow-up information received on 27-FEB-2023.  Reporter's Comments: This information was received from consumer via Adverse Event Reporting Form. Patient reported high blood pressure and increased heart palpitations. Physician was aware, no additional information was provided. It was unknown if the reporter considered  increased blood pressure and palpitations aggravated to be related to  covid vaccine.  Summary of changes: Laboratory data added, new event added, narrative updated.  Follow-up information received on 21 Mar 2023.  This information was received from consumer via Adverse Event Reporting Form. Patient stated she was now taking metoprolol succinate for high blood pressure and palpitations. platelets dropped after having covid booster as well as other blood counts and liver enzymes went really high. zejula did give her mild low platelet counts. no additional details reported. Azelastine, benadryl allergy, melatonin, miralax, metoprolol succinate, ondansetron, prochlorperazine maelate, stool softener, women's multivitamin, Concomitant product included stool softener, women's multivitamin. Co-suspect products included Covid booster  and moderna covid product used for unknown indication. It was unknown if the reporter considered  pneumonia, influenza-like symptoms, nausea, vomiting, fever, chills, headache, muscle pain, lab test abnormal, platelet count decreased, white blood cell count decreased, neutrophil count decreased, elevated liver enzymes, heartbeats increased, diastolic blood pressure increased, increased blood pressure and palpitations aggravated, adverse drug reaction, full blood count decreased and palpitations aggravated to be related to  covid vaccine and Covid booster. It was unknown if the reporter considered full blood count decreased to be related to  covid vaccine.  Summary of changes: New event details  Follow-up information received on 20-APR-2023.  This information was received from consumer via Adverse Event Reporting Form. Patient stated that When she was getting the covid vaccine, her platelets and blood was dropping so low, and her liver enzymes went up. She got every side effect on the cdc (centers for disease control) website with the moderna vaccine. (07/2022). Patient had the pfizer vaccine in october, and she had the same reaction in blood work. The pfizer vaccine did not  give her the side effects like the moderna, though. Zejula kept patients platelets borderline low. They said she had mild thrombocytopenia also reported that her blood pressure and heart palpitations have been better since she started the metoprolol. Patient reported that her platelets go way up when she was off of the zejula for a week. Dechallenge was unknown for zejula. It was unknown if the reporter considered thrombocytopenia to be related to covid vaccine. Concomitant medication included  metoprolol, prochlorperazine. Summary of Changes: Laboratory data added, new dose regimen added, action taken updated, concomitant medication added, treatment drug added, new event added, event outcome updated, narrative updated.  Follow-up information received on: 19-MAY-2023. This case reported by consumer via Adverse Event Product/Complaint Form.The patient said, she stopped taking it for a week around the 24th to take the shingles vaccine. When she took a vaccine, her platelets drop substantially. They were usually borderline with the zejula. She had an incisional hernia from all the surgeries but they won't repair it while she was on zejula because she was immunocompromised and her platelet count. With her blood pressure medication her blood pressure was back to where it was. It was unknown if reporter considered events to be related to covid vaccine. Summary of changes: Lab data updated, Product detail updated, Events added.