Age: 67.0
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Hypotension, Influenza like illness, Injection site erythema, Intentional product use issue, Joint swelling
Clinical narrative: plaque in the aorta; high b/p / elevated blood pressure; lowB/P; contispation comes and goes; gaining weight/gaining weight no edema fluctuating / weight gain noted; feeling out of it; skin breakouts / bump on forehead; fatigue; both arms achy/ soreness in her arms / pain in arm; redness at injection site; itchy skin/ Itching in arms; armpits swollen; Flu like symptoms; drowsiness; Joint swelling; pain in arm neck; chest pressure; Pt stated for today's dose she will take take only 1 capsule and will take 1 capsule tomorrow and she has has only 2 caps on hand; 200mg QD malignant neoplasm of peritoneum 185-190lbs; sore throat; coughing; Brittle nails; CoVid; dizzy/dizziness; blood pressure dipped; slight sore muscles / muscle pains/aches; slight nausea; cold/hot symptoms; This serious case was reported by a consumer via patient support programs and described the occurrence of aortic plaque in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, niraparib capsule (batch number 2057806, expiry date 30-APR-2024), (batch number 2416866, expiry date 30-JUN-2024) and (batch number 2416861, expiry date 31-JUL-2024) for malignant peritoneal neoplasm and metastases to abdominal cavity, COVID-19 VACCINE (COVID VACCINE) for prophylaxis and amlodipine for aortic plaque.   Concurrent medical conditions included neuropathy (the patient had pre-existing neuropathy, Ongoing, improved). Additional subject notes included other condition unknown. Concomitant products included amlodipine besilate (Norvasc), famotidine, macrogol (Miralax) and paracetamol (Tylenol Arthritis).   On 30-MAR-2022, the patient received Shingrix. On an unknown date, the patient received Influenza vaccine (unknown arm). On 23-MAR-2022, the patient started niraparib (oral) 200 mg once daily (200 mg daily). On 18-OCT-2022, the dose was changed to 100 mg once daily (100 mg daily). The dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the patient received COVID VACCINE (unknown arm) and amlodipine. The dose was changed to 10 mg. In MAR-2022, not applicable after receiving Shingrix and Influenza vaccine and less than a week after starting niraparib, the patient experienced muscle pain (Verbatim: slight sore muscles / muscle pains/aches) and nausea (Verbatim: slight nausea). On 31-MAR-2022, the patient experienced dizziness (Verbatim: dizzy/dizziness) and blood pressure decreased (Verbatim: blood pressure dipped). In MAY-2022, the patient experienced covid-19 (Verbatim: CoVid). In JUN-2022, the patient experienced brittle nails (Verbatim: Brittle nails). On an unknown date, the patient experienced aortic plaque (Verbatim: plaque in the aorta) (serious criteria GSK medically significant), blood pressure high (Verbatim: high b/p / elevated blood pressure), low blood pressure (Verbatim: lowB/P), constipation (Verbatim: contispation comes and goes), weight gain (Verbatim: gaining weight/gaining weight no edema fluctuating / weight gain noted), sore throat (Verbatim: sore throat), cough (Verbatim: coughing), feeling abnormal (Verbatim: feeling out of it), skin breakout (Verbatim: skin breakouts / bump on forehead), fatigue (Verbatim: fatigue), pain in arm (Verbatim: both arms achy/ soreness in her arms / pain in arm), injection site erythema (Verbatim: redness at injection site), pruritus (Verbatim: itchy skin/ Itching in arms) and local swelling (Verbatim: armpits swollen). the patient experienced feeling hot and cold (Verbatim: cold/hot symptoms), influenza-like symptoms (Verbatim: Flu like symptoms), drowsiness (Verbatim: drowsiness), swollen joints (Verbatim: Joint swelling), neck pain (Verbatim: pain in arm neck), chest pressure (Verbatim: chest pressure), intentional dose decrease (Verbatim: Pt stated for today's dose she will take take only 1 capsule and will take 1 capsule tomorrow and she has has only 2 caps on hand) and off label dosing (Verbatim: 200mg QD malignant neoplasm of peritoneum 185-190lbs). The subject was treated with zingiber officinale (Ginger), acetylsalicylic acid (Asa) and rosuvastatin calcium (Crestor). The dose of niraparib was increased. The dose of amlodipine was increased. The outcome of the muscle pain, nausea, dizziness, brittle nails, aortic plaque, blood pressure high, constipation, weight gain, sore throat, cough, skin breakout, fatigue, pain in arm, drowsiness, swollen joints, neck pain and chest pressure were not recovered/not resolved and the outcome of the blood pressure decreased and feeling abnormal were recovering/resolving and the outcome of the low blood pressure, injection site erythema, local swelling, intentional dose decrease and off label dosing were unknown and the outcome of the covid-19, pruritus and influenza-like symptoms were recovered/resolved and the outcome of the feeling hot and cold were unknown (duration 3 days).   It was unknown if the reporter considered the aortic plaque, muscle pain, nausea, dizziness, blood pressure decreased, blood pressure high, low blood pressure, constipation, weight gain, covid-19, sore throat, cough, brittle nails, feeling abnormal, skin breakout, fatigue, pain in arm, injection site erythema, pruritus, local swelling, feeling hot and cold, influenza-like symptoms, drowsiness, swollen joints, neck pain and chest pressure to be related to Shingrix and niraparib. It was unknown if the reporter considered the aortic plaque, blood pressure high, low blood pressure, constipation, weight gain, sore throat, cough, feeling abnormal, skin breakout, influenza-like symptoms, drowsiness, swollen joints, neck pain and chest pressure to be related to Influenza vaccine and niraparib. The reporter considered the fatigue, pain in arm, injection site erythema, pruritus, local swelling and feeling hot and cold to be related to Influenza vaccine.     It was unknown if the company considered the aortic plaque, muscle pain, nausea, dizziness, blood pressure decreased, blood pressure high, low blood pressure, constipation, weight gain, covid-19, sore throat, cough, brittle nails, feeling abnormal, skin breakout, fatigue, pain in arm, injection site erythema, pruritus, local swelling, feeling hot and cold, influenza-like symptoms, drowsiness, swollen joints, neck pain and chest pressure to be related to Shingrix. It was unknown if the company considered the aortic plaque, blood pressure high, low blood pressure, constipation, weight gain, sore throat, cough, feeling abnormal, skin breakout, influenza-like symptoms, drowsiness, swollen joints, neck pain and chest pressure to be related to Influenza vaccine. The company considered the fatigue, pain in arm, injection site erythema, pruritus, local swelling and feeling hot and cold to be related to Influenza vaccine. The company considered the aortic plaque to be unrelated to niraparib. It was unknown if the company considered the muscle pain, nausea, dizziness, blood pressure decreased, blood pressure high, low blood pressure, constipation, weight gain, covid-19, sore throat, cough, brittle nails, feeling abnormal, skin breakout, fatigue, pain in arm, injection site erythema, pruritus, local swelling, feeling hot and cold, influenza-like symptoms, drowsiness, swollen joints, neck pain and chest pressure to be related to niraparib.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: This information was received from consumer. Patient received niraparib as zejula. Adverse Events: slight sore muscles, slight nausea. Other concomitant medications included Probiotic, Vitamin (type not specified).  Follow up information was received on 31-Mar-2022. This follow-up was considered significant. Reporter's Comments: This information was received from consumer. Patient stated she got her Shingle (Shingrix) booster shot yesterday. This morning felt dizzy and her blood pressure dipped 100 vs usually 129-130, she then checked again and the 3 time it was normal when checked blood pressure in sitting position.  Summary of Changes: New lab data, suspect product and events added.  Follow-up information received on 04-APR-2022. This follow-up was considered significant Reporter's Comments: Start Date 23March2022 on 200mg for Peritoneal cancer 1st line Weight 170lb. Dose: 200mg daily AM with yogurt. Adverse Events: slight sore muscles resolved, slight nausea resolved with ginger, had shingles vaccine last week with low, high blood pressure and dizziness previously reported, now resolved; Saw primary care physician and electrocardiogram was normal/stable. First lab: 30Mar2022 results were normal. Next lab: scheduled weekly Apr 6, Apr 13, Apr20,2022. No scheduled appointment with oncologist. Patient confirmed appetite good, hydration good, blood pressure stable/controlled, sleeping well most nights. Patient denied diarrhea, constipation, vomiting, skin issues. Other concomitant medications included claritin 10mg daily. No recent scan, specialist visit, emergency room visit, hospital admission, no new drug allergies, no missed doses, no refill needed. Summary of Changes: Outcome of event, treatment drug, dosage regimen, patient weight, lab data.  Follow-up information received on 29-APR-2022. This follow-up was considered significant. Reporter's Comments: This case was received from consumer. Patient reported slight sore muscle resolved, slight nausea came and went unchanged , constipation came and went, few episodes of dizziness, gained weight. No edema. Summary of Changes: Pregnancy detail, weight, Lab data, Action taken updated, Events added.  Follow-up information received on 23-MAY-2022. This follow-up was considered significant Reporter's Comments: Adverse event: Patient called in tonight to report she had Covid; sore throat, coughing, elevated blood pressure, PCP sent her a RX for Paxlovid. Summary of Changes: outcome of event, event added, dosage regimen, rechallenge results.   Follow-up information received on 30-JUN-2022. This follow-up was considered significant. Reporter's Comment: The patient was not hold for covid-19 but had Covid mid-May that was resolved, nausea resolved, constipation comes and goes, gaining weight and no edema. The concomitant medication included as probiotic and vitamin. Summary Of Changes: patient's demographic details, historical condition, concomitant medication, event outcome and narrative details were updated.  Follow-up information received on 18-JUL-2022. This follow-up was considered significant. Reporter's Comments: This case was reported by consumer. Patient said she experienced a little of neuropathy and her finger nails seemed more brittle within the last month. 1 day after receiving Shingrix, the patient had dizziness and blood pressure decreased, less than a month after receiving Shingrix, the patient had blood pressure high, low blood pressure, constipation and weight gain, between 1 and 3 months after receiving Shingrix, the patient had COVID-19, between 2 and 3 months after receiving Shingrix, the patient had brittle nails and less than 3 months after receiving Shingrix, the patient had sore throat and cough. Summary of changes:  Suspect product dosage regimen added, Event added.  Follow-up information received on 28-Sep-2022. This follow-up was considered significant.  Reporter's Comments: This case was reported by consumer. Adverse event reported as feeling out of it and slight nausea when taking Amlodipine and Zejula, but better now, skin breakouts and sees dermatologist, received flu shot and Covid booster shot on same day last week which caused fatigue, both arms achy, redness at injection site, itchy skin, and armpits swollen, cold/hot symptoms for 3 days; Last lab 29Aug2022 results good and CA125 4. Follow-up reported constipation comes and goes, gaining weight, no edema fluctuating, pre-existing neuropathy was improved. Concomitant Medications: Norvasc 5mg QD, Claritin 10mg prn, Famotidine 20mg prn, Probiotic prn, Multi-Vitamin QD, Miralax 17GM prn, Tylenol arthritis 650mg prn. It was unknown if the reporter considered the muscle soreness, nausea, dizziness, blood pressure decreased, blood pressure high, low blood pressure, constipation, weight gain, covid-19, sore throat, cough, brittle nails, feeling abnormal, skin breakout, fatigue, pain in arm, injection site erythema, itchy skin, local swelling and feeling hot and cold to be related to amlodipine. It was unknown if the reporter considered the muscle soreness, nausea, dizziness, blood pressure decreased, blood pressure high, low blood pressure, constipation, weight gain, covid-19, sore throat, cough, brittle nails, feeling abnormal and skin breakout to be related to Covid Vaccine. The reporter considered the fatigue, pain in arm, injection site erythema, itchy skin, local swelling and feeling hot and cold to be related to Covid Vaccine. Summary of Changes: Suspect drug details for dosage regimen was added, concomitant drugs were added, new events were added and narrative updated.  Follow-up information received on 18-Oct-2022.  Reporter's Comments: This case was reported by consumer. Patient stated she had the flu and covid shot simultaneously in each arm. She stated she had itching and soreness in her arms and flu like symptoms which have now resolved. Took about 4 to 5 days for symptoms to resolve. Patient stated for today's dose she would take only 1 capsule and would take 1 capsule tomorrow and she has only 2 caps on hand. It was unknown if the reporter considered the flu like symptoms to be related to Covid Vaccine and amlodipine. Summary of Changes: New event was added, event outcome was updated, suspect drug details for dosage regimen and action taken were updated and narrative updated.  Follow-up information received on 08-DEC-2022.  Reporter's Comments: This information was received from consumer. Adverse event: Saw dermatologist who froze large bump on forehead. Concomitant Medications: Norvasc 5mg QD. Summary of Changes: dosage regimen.  Follow-up information received on 18-Jan-2023.  Reporter's Comments: This information received from consumer. Adverse event: Patient said had been taking Zejula and Amlodipine in the morning for the last 10 months but recently she experienced drowsiness. Concomitant Medications: Amlodipine, start date 23 March 2022 at 200 mg-Peritoneal 1st line therapy 170lbs. It was unknown if the reporter considered the drowsiness to be related to Covid Vaccine and Amlodipine. Summary of changes: New dosage regimen added, new event added.  Follow-up information received on 14-Feb-2023. Reporters comment:This information received from consumer. Adverse event: weight gain noted, joint swelling noted Follow up: fatigue, constipation (came and went), pre-existing neuropathy (better). Start date 23 March 2022 at 200 mg-Peritoneal 1st line therapy 185-190 lbs. It was unknown if the reporter considered the Joint swelling to be related to Covid Vaccine and Amlodipine. Summary of changes: Event, Event outcome, dosage regimen were added.  Follow-up information received on 15-MAR-2023.  This information was received from consumer. Adverse event: New: passed cardiac stress test, mild nausea Follow up: weight gain, fatigue, constipation (comes and goes), pre-existing neuropathy (better).On an unknown date, the dose was continued to 200 mg once daily (200 mg daily) (batch number 2057808, expiry date 30th June 2024, (batch number 2342678, expiry date 31st May 2024), (batch number 2342676, expiry date 31st May 2024), (batch number 2416866, expiry date 30th June 2024), (batch number 2416862, expiry date 31st July 2024) and (batch number 2416864, expiry date 31st July 2024). Summary of changes: outcome of event, lab data.  Follow-up information received on 21-MAR-2023.  This information was received from consumer. Adverse event: was experiencing some chest pressure, pain in arm neck- went to see physician and physician said it could be heart related, physician said there was some plaque in the aorta thus Dr added some new meds to slow the progression. Physician increased her amlodipine to 10mg, added 81mg ASA and crestor 10mg. Also reported muscle pains/aches, constipation and fatigue. On an unknown date, the dose was continued to 200 mg once daily (200 mg daily) (batch number 2700821, expiry date 31st July 2024). In SEP-2022, the patient received COVID VACCINE (unknown arm). In SEP-2022, the patient received Influenza vaccine (unknown arm). It was unknown if the reporter considered the aortic plaque, neck pain and chest pressure related to COVID-19 VACCINE (COVID VACCINE and amlodipine Summary of changes: treatment drug, event added.; Sender's Comments: Aortic arteriosclerosis is a unlisted event which is considered unrelated to GSK study drug Niraparib.