Sex: F
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Inappropriate schedule of product administration, Nausea, Palpitations, Paraesthesia
Clinical narrative: had a lot of nausea; abdominal pain; vomiting; sun sensitivity; Tingly; Red skin / little red spots coming and going on her face and arms; Patient stated she has  toxins in system.; kind of like acne; sides of her toes turned purple; felt like they were burning; constipation; Skin more easily sunburn; racing/pounding heart; Taking Zejula 200 mg bid/ taking Zejula TID (thrice a day); This case was reported by a consumer via patient support programs and described the occurrence of nausea in a 59 years old female patient who received niraparib (Zejula) capsule (batch number 8720490, expiry date 31st March 2022) for malignant neoplasm of ovary.   Concurrent medical conditions included drug allergy (Ibuprofen). Concomitant products included paracetamol (Acetaminophen), vitamin d, apixaban (Eliquis), docusate sodium, hydrocodone bitartrate + paracetamol (Norco), cyanocobalamin (Vitamin B12) and ondansetron.   On 9th January 2020, the patient started Zejula 200 mg twice daily (400 mg daily). On an unknown date, the dose was changed to an unknown dose 3 times daily. On an unknown date, an unknown time after starting Zejula, Acetaminophen and vitamin d, the patient experienced nausea. The dose of Zejula was increased. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Zejula.  Additional details: Patient was on zejula 2 daily for a few months, with no problems. she was instructed to increase the dose to thrice  daily. She even did that for 3 doses and had a lot of nausea. she felt that the dose might be too much for her. Concomitant medication included multivitamin, probiotic and vitamin B complex.   Follow up information received from consumer on 23 Apr 2020 via Zejula: Concurrent medical conditions included drug allergy (Ibuprofen). Concomitant products included ondansetron (Ondansetron Odt), vitamin D-1000. On an unknown date, an unknown time after starting Zejula, Acetaminophen and vitamin d, the patient experienced abdominal pain and vomiting. On an unknown date, the outcome of the abdominal pain and vomiting were unknown. The reporter considered the abdominal pain and vomiting to be related to Zejula. Patient said on 3 a day she had abdominal pain and vomtiing, which was why physician put her back down to 2 a day.  Follow up information received from consumer via Zejula on 13 Aug 2020: The patient received niraparib (Zejula) capsule (batch number 9722426, expiry date 31st October 2022) for malignant neoplasm of ovary. On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced sun sensitivity and inappropriate schedule of drug administration. On an unknown date, the outcome of the sun sensitivity and inappropriate schedule of drug administration were unknown. It was unknown if the reporter considered the sun sensitivity to be related to Zejula. The patient reported sun sensitivity.  Follow up information received from consumer via Zejula on 13 Aug 2020: The patient received niraparib (Zejula) capsule (batch number 9722426, expiry date 31st October 2022) for malignant neoplasm of ovary. Concomitant products included nutritional supplement (Probiotic). On an unknown date, an unknown time after starting Zejula, the patient experienced tingling and skin red. On an unknown date, the outcome of the tingling and skin red were unknown. It was unknown if the reporter considered the tingling and skin red to be related to Zejula. The patient reported sun sensitivity. The patient gets tingly and red skin when she was in the sun, never had this with other medications.  Follow up information received from consumer via Zejula on 04 Jan 2021: The patient received niraparib (Zejula) capsule (batch number 9266891, expiry date 30th September 2022) for malignant neoplasm of ovary. On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced ill-defined disorder. The dose of Zejula was decreased (Dechallenge was unknown). On an unknown date, the outcome of the ill-defined disorder was unknown. It was unknown if the reporter considered ill-defined disorder to be related to Zejula. The patient stated she had  toxins in system.  Follow up information received from consumer via Zejula  on 01 Feb 2021: The patient received niraparib (Zejula) capsule (batch number 1359483, expiry date 31st January 2023) for malignant neoplasm of ovary. On an unknown date, the dose was changed to 200 mg once daily (200 daily). On an unknown date, an unknown time after starting Zejula, the patient experienced acne, skin discoloration and burning foot. The dose of Zejula was decreased (Dechallenge was unknown). On an unknown date, the outcome of the acne and skin discoloration were unknown and the outcome of the burning foot was recovered/resolved. It was unknown if the reporter considered the acne, skin discoloration and burning foot to be related to Zejula. The patient reported little red spots coming and going on her face and arm.. She stated it looks kind of like acne, but was not pustular. She also reported an incident where the sides of her toes turned purple and fell like they were burning but this resolved a few hours later.  Follow up information received from consumer via Zejula on 20 Apr 2021: The recent dose of Zejula was reported as 200 mg once daily (200 mg daily). On an unknown date, the patient experienced sunburn and constipation. On an unknown date, the outcome of the sunburn and constipation were unknown. It was unknown if the reporter considered the sunburn and constipation to be related to Zejula. The patient reported that, skin more easily sunburned if outdoors and would have bouts of constipation depend on foods she eats.   Follow up information received from consumer via on 25th February 2022: The patient's demographics details were updated. The patient received 1st dose Shingrix vaccine while on Zejula and experienced racing/pounding heart several hours after the injection. The racing/pounding heart was resolved after few hours. No other information found during the follow-up. It was unknown if the reporter considered the racing/pounding heart to be related to Shingrix and Zejula.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR024858: