Age: 63.0
Sex: F
Vaccine: FLUX, RVX
Symptoms: Feeling abnormal, Full blood count decreased, Immune system disorder, Malaise, Platelet count decreased
Clinical narrative: Lung biopsy; Blood counts were low; Platelets were on the border/ platelets go low; for my shoulder; l have vision changes-sometimes i have to get close to the tv; I have shoulder pain-i got a steroid shot, and it worked for 30 minutes, then it stopped. The left is worse than the right; its real blurry/blurriness/Blurred vision; white film from nose- milky; was too tired; sick for two weeks; feeling so bad; immune system was down; caught a virus or something; she missed a dose; I had 2 days where i had episodes of vertigo. it was on the 3rd, and 4th (of september).; This non-serious case was reported by a consumer via patient support programs and described the occurrence of lung biopsy in a 62-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included niraparib tosylate monohydrate (Zejula) capsule (batch number 2416863, expiry date 31-JUL-2024), (batch number 2700823, expiry date 31-JUL-2024) and (batch number 2726925, expiry date 31-AUG-2024) for ovarian cancer and malignant peritoneal neoplasm, niraparib tosylate monohydrate (Zejula) tablet (batch number 1950860, expiry date 31-MAY-2026) for malignant peritoneal neoplasm, influenza vaccine for prophylaxis and ibuprofen for product used for unknown indication.   The patient's past medical history included hypertension. Concurrent medical conditions included malignant peritoneal neoplasm and penicillin allergy (Penicillin G potassium). Concomitant products included simeticone (Gas-X), metoprolol succinate, ubidecarenone (Coq10), rosuvastatin calcium, atorvastatin calcium (Lipitor), metformin hydrochloride, glibenclamide (Glyburide), glipizide + metformin, metoprolol, salbutamol (Albuterol), dextran 70 + hypromellose (Bion Tears), lisinopril, rosuvastatin, loratadine (Claritine) and salbutamol sulfate (Albuterol Sulfate Hfa).   On 13-SEP-2023, the patient received RSV vaccine. In SEP-2022, the patient started Zejula (oral) 100 mg 200 mg daily (200 mg daily). The dose was changed to 100 mg daily (100 mg daily). The dose was changed to 100 mg daily (100 mg daily). On 25-AUG-2023, the dose was changed to 100 mg daily (100 mg daily). On an unknown date, the patient started Zejula (oral) 100 mg daily (100 mg daily). On 13-SEP-2023, the patient started influenza vaccine. On an unknown date, the patient started ibuprofen. On 03-SEP-2023, an unknown time after receiving RSV vaccine, Zejula and Zejula, the patient experienced vertigo (Verbatim: I had 2 days where i had episodes of vertigo. it was on the 3rd, and 4th (of september).). On 29-SEP-2023, the patient experienced missed dose (Verbatim: she missed a dose ). On an unknown date, the patient experienced lung biopsy (Verbatim: Lung biopsy), full blood count decreased (Verbatim: Blood counts were low), platelet count decreased (Verbatim: Platelets were on the border/ platelets go low), unspecified disorder of joint of shoulder region (Verbatim: for my shoulder), abnormal vision (Verbatim: l have vision changes-sometimes i have to get close to the tv), arthralgia aggravated (Verbatim: I have shoulder pain-i got a steroid shot, and it worked for 30 minutes, then it stopped. The left is worse than the right), blurred vision (Verbatim: its real blurry/blurriness/Blurred vision), nasal discharge (Verbatim: white film from nose- milky), tiredness (Verbatim: was too tired), sickness (Verbatim: sick for two weeks), feeling bad (Verbatim: feeling so bad), immune system disorder (Verbatim: immune system was down) and viral infection (Verbatim: caught a virus or something). The patient was treated with steroids nos (Steroid Shot (Nos)). Zejula was interrupted. The action taken with Zejula was unknown. The action taken with ibuprofen was unknown. On 05-SEP-2023, the outcome of the vertigo was resolved (duration 2 days). The outcome of the lung biopsy, full blood count decreased, platelet count decreased, unspecified disorder of joint of shoulder region, abnormal vision, arthralgia aggravated, nasal discharge and missed dose were unknown and the outcome of the blurred vision was not resolved and the outcome of the tiredness, sickness, feeling bad, immune system disorder and viral infection were resolving.   It was unknown if the reporter considered the lung biopsy, full blood count decreased, platelet count decreased, unspecified disorder of joint of shoulder region, abnormal vision, arthralgia aggravated, blurred vision, nasal discharge, vertigo, tiredness, sickness, feeling bad, immune system disorder and viral infection to be related to RSV vaccine and Zejula. It was unknown if the reporter considered the lung biopsy, full blood count decreased, platelet count decreased, unspecified disorder of joint of shoulder region, abnormal vision, arthralgia aggravated, nasal discharge, tiredness, sickness, feeling bad, immune system disorder and viral infection to be related to Zejula and Zejula. The reporter considered the blurred vision and vertigo to be unrelated to Zejula.  It was unknown if the company considered the lung biopsy, full blood count decreased, platelet count decreased, unspecified disorder of joint of shoulder region, abnormal vision, arthralgia aggravated, blurred vision, nasal discharge, vertigo, tiredness, sickness, feeling bad, immune system disorder and viral infection to be related to RSV vaccine and Zejula. It was unknown if the company considered the lung biopsy, full blood count decreased, platelet count decreased, unspecified disorder of joint of shoulder region, abnormal vision, arthralgia aggravated, nasal discharge, tiredness, sickness, feeling bad, immune system disorder and viral infection to be related to Zejula and Zejula. The company considered the blurred vision and vertigo to be unrelated to Zejula.   Additional Information: GSK Receipt Date: 16-Jan-2023 Reporter's Comments: This information was received from Nurse via Adverse Event/Product Complaint Form. Patient reported Zejula was being held for 2 weeks due to having a lung biopsy, last dose of Zejula was taken on 12 Jan 2023. Concomitant medications included Gas-x 125 mg capsule, Metoprolol succinate, Coq10 50 mg tab chew, Claritin 10 mg capsule, Rosuvastatin calcium 10 mg tablet, Lipitor 10 mg tablet, Metformin HCL 500 mg tablet, Glyburide 5 mg tablet.  Follow up information receive don 14 Mar 2023 This information was received from Nurse via Adverse Event/Product Complaint Form. Patient reported she had a dose hold the last time her blood counts were low and her platelets were on the border and her dose was held by prescriber. She also reported she messed up and took ibuprofen for 2 weeks for her shoulder. She should had called that made her platelets go low. She also reported having a dose change. No additional details given, prescriber was aware. After being held on 12 Jan 2023 patient restarted the zejula on 200 mg daily oral (batch number 2700821, expiry date 31 Jul 2024) and continued. It was unknown if reporter and company considered the lung biopsy, full blood count decreased and unspecified disorder of joint of shoulder region to be related to ibuprofen. Reporter considered the platelet count decreased to be related to ibuprofen. Summary of changes: Event tab, product tab and patient tab updated.  Follow-up information received on 15-MAY-2023.  This information was received from nurse via Adverse Event Reporting Form. Patient reported that she had vision changes-sometimes she have to get close to the tv (television), even if she was wearing her glasses, its real blurry. Patient had a shoulder pain for which she got a steroid shot, and it worked for 30 minutes, then it stopped. The left was worse than the right. Prescriber was aware. Concomitant medication included Metformin-glipizide, metoprolol, albuterol, bion tears, lisinopril, rosuvastatin, Claritin. Concomitant medication included Claritine (Claritin NOS) used for unknown indication and dose. Dechallenge was unknown for zejula. It as unknown id reporter considered  Summary of Changes: Current condition added, allergy added, New dose regimen added, action taken updated, concomitant medication added, treatment drug added, new events added, narrative updated.  Follow up information received on: 12-JUL-2023. This case reported by consumer (Nurse) via Adverse Event/Product Complaint Form. Patient reported, "she was having her eyes checked today (On day of report), because of blurriness". Prescriber aware, and did not believed blurriness was related to Zejula. Other concomitant product included Bion Tears 0.1-0.3%. Summary of changes: Dosage regimen added, Event verbatim and outcome updated.  Follow up information received on: 10-AUG-2023. This case reported by consumer via Adverse Event/Product Complaint Form. Patient reported occasional blurred vision and white film from nose- milky. Waiting until after 25 Aug 2023 when had a lower GI (Gastrointestinal) study to fix eye problem.  Summary of changes: Event added.  Follow up information received on: 11-SEP-2023. This case reported by consumer via Adverse Event/Product Complaint Form. Patient had 2 days where she had episodes of vertigo. it was on the 3rd, and 4th (of september). after that, Patient did exercises so she wouldn't have it any more. both of my doctor's said it would not be from the medication zejula. Patient was off of zejula from 11 August to 25 August 2023 for colonoscopy-lower gl (Gastrointestinal) study was AE(Adverse event) reported on 10 August2023.It was unknown if reporter consider events Vertigo to be related to ibuprofen. Summary of changes: Lab data added, product and event tab updated.  Follow-up information received on 11-OCT-2023. This case reported by consumer via adverse event report/product complaint form. Patient reported she missed a dose on 29 Sep 2023. Patient forgot; she was busy one of those days she had all the grandkids. She had a reminder on her electronic device was too tired to read it, patient reported she would have this same level of tiredness from having all the grandkids before starting on the zejula. She learned a lesson on 13 Sep 2023, got the flu shot and Rsv (shot) and should not have taken them together. She was sick for two weeks, was feeling so bad. she (md) said her immune system was down and caught a virus or something. No other details were given. It was unknown if the reporter tiredness, sickness, feeling bad, immune system disorder and viral infection to be related to Influenza vaccine and Ibuprofen. Summary of changes: product tab and event tab were updated.