Age: 85.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sleep disorder
Clinical narrative: Weak; Her arm was also sore and this was waking her up at night; Headache; Her arm was also sore and this was waking her up at night; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weak), SLEEP DISORDER (Her arm was also sore and this was waking her up at night), HEADACHE (Headache) and PAIN IN EXTREMITY (Her arm was also sore and this was waking her up at night) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RUCAPARIB CAMSYLATE (RUBRACA) for Ovarian cancer.    The patient's past medical history included Blood transfusion (twice). Concurrent medical conditions included Anemia, Asthenia (increased at the beginning of Rubraca therapy), Balance disorder, Walking aid user, Neuropathy peripheral, Varicose vein, Taste disorder and Decreased appetite.   On 21-Dec-2021, the patient started RUCAPARIB CAMSYLATE (RUBRACA) (Oral) 600 milligram twice a day. On 21-Apr-2022, RUCAPARIB CAMSYLATE (RUBRACA) (Oral) dosage was changed to 300 milligram twice a day. On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2022, the patient experienced SLEEP DISORDER (Her arm was also sore and this was waking her up at night), HEADACHE (Headache) and PAIN IN EXTREMITY (Her arm was also sore and this was waking her up at night). On an unknown date, the patient experienced ASTHENIA (Weak). At the time of the report, ASTHENIA (Weak) had not resolved and SLEEP DISORDER (Her arm was also sore and this was waking her up at night), HEADACHE (Headache) and PAIN IN EXTREMITY (Her arm was also sore and this was waking her up at night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: low (Low) Low. On an unknown date, Positron emission tomogram: good result (normal) Good result.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was treated with Rubraca from 21-DEC-2021. After on unknown date, that patient experienced rash on her legs, fatigue, decreased energy, and needed to rest in between activities, constipation alternating with diarrhea. The patient used unspecified stool softeners. Her pre-existing neuropathy of hands and feet was more intense. Also experienced hair thinning, food tasted different, anemia, dry skin. On unknown date, physician held Rubraca for 2 weeks due to low hemoglobin that needed 2 blood transfusion. It was unknown if ill effects were missed dose. On an unknown date, patient restarted Rubraca treatment at same dose. The patient's preexisting varicose vein was pushing that burst and left a wound 3 inches in diameter. The physician aware and advised the patient to go to emergency room. On 05-May-2022, follow up was done with patient where she stated she received COVID-19 vaccine. On an unknown date, the patient had a positron emission tomography that showed "good results". On 22-Apr-2022, reported as two weeks ago, the patient restarted Rubraca at 300 twice daily due to the good results. The burst varicose vein was healing, and the patient was scheduled for a dermatology appointment next week. On 02-May-2022, the patient received a COVID booster vaccine. Since she received the vaccine. the patient was weak (previously reported) with a headache, arm was also sore, and this was her up at night. The patient's preexisting neuropathy remain the same. Therapy with Rubraca Was maintained at the dose. The reporter assessed the causal relationship between Rubraca and the events headache, her arm was sore and this was waking her up at night as not related: providing the (COVID vaccine) to suggest a causal relationship.