Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: Immature Red blood cells in her blood; decreased appetite; Shortness of breath; Decreased energy; Hemoglobin went 8, 10 and 11.8; Sick after second moderna booster for 24 hours/could not eat or drink; Felt so bad/ not feeling good/not feeling too well; Diarrhea; Nausea; 105 Temperature/fever; Vomiting; Dehydrated; Lost 8 pounds/weight loss; Sick after second moderna booster for 24 hours/Confusion; Sick after second moderna booster for 24 hours//could not walk; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (Lost 8 pounds/weight loss), MALAISE (Felt so bad/ not feeling good/not feeling too well), DIARRHOEA (Diarrhea), RETICULOCYTE COUNT INCREASED (Immature Red blood cells in her blood), DECREASED APPETITE (decreased appetite), DYSPNOEA (Shortness of breath), ASTHENIA (Decreased energy), DEHYDRATION (Dehydrated), HAEMOGLOBIN DECREASED (Hemoglobin went 8, 10 and 11.8), NAUSEA (Nausea), PYREXIA (105 Temperature/fever), VOMITING (Vomiting), CONFUSIONAL STATE (Sick after second moderna booster for 24 hours/Confusion), GAIT DISTURBANCE (Sick after second moderna booster for 24 hours//could not walk) and HYPOPHAGIA (Sick after second moderna booster for 24 hours/could not eat or drink) in a 69-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 Malignant neoplasm of ovary.    No Medical History information was reported.   On 05-Jan-2021, the patient started RUCAPARIB CAMSYLATE (RUBRACA) (Oral) 400 milligram twice a day. On 25-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, RUCAPARIB CAMSYLATE (RUBRACA) (Oral) dosage was changed to 400 milligram twice a day. In January 2022, the patient experienced WEIGHT DECREASED (Lost 8 pounds/weight loss) (seriousness criterion medically significant) and DEHYDRATION (Dehydrated) (seriousness criterion medically significant). On 25-Jan-2022, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (105 Temperature/fever) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 26-Jan-2022, the patient experienced MALAISE (Felt so bad/ not feeling good/not feeling too well) (seriousness criterion medically significant). On an unknown date, the patient experienced RETICULOCYTE COUNT INCREASED (Immature Red blood cells in her blood) (seriousness criterion medically significant), DECREASED APPETITE (decreased appetite) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), ASTHENIA (Decreased energy) (seriousness criterion medically significant), HAEMOGLOBIN DECREASED (Hemoglobin went 8, 10 and 11.8) (seriousness criterion medically significant), CONFUSIONAL STATE (Sick after second moderna booster for 24 hours/Confusion) (seriousness criterion medically significant), GAIT DISTURBANCE (Sick after second moderna booster for 24 hours//could not walk) (seriousness criterion medically significant) and HYPOPHAGIA (Sick after second moderna booster for 24 hours/could not eat or drink) (seriousness criterion medically significant). The patient was treated with FERROUS SULFATE (SLOW IRON) for Reticulocyte count increased and Haemoglobin decreased, at an unspecified dose and frequency. On 28-Jan-2022, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, WEIGHT DECREASED (Lost 8 pounds/weight loss) had not resolved, MALAISE (Felt so bad/ not feeling good/not feeling too well), DIARRHOEA (Diarrhea), RETICULOCYTE COUNT INCREASED (Immature Red blood cells in her blood), DECREASED APPETITE (decreased appetite), DYSPNOEA (Shortness of breath) and ASTHENIA (Decreased energy) outcome was unknown, DEHYDRATION (Dehydrated) and HAEMOGLOBIN DECREASED (Hemoglobin went 8, 10 and 11.8) was resolving and PYREXIA (105 Temperature/fever), CONFUSIONAL STATE (Sick after second moderna booster for 24 hours/Confusion), GAIT DISTURBANCE (Sick after second moderna booster for 24 hours//could not walk) and HYPOPHAGIA (Sick after second moderna booster for 24 hours/could not eat or drink) had resolved. fliud and BRAT diet    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Haemoglobin: 8 (Low) 8, 10 (Low) 10 and 11.8 (Low) 11.8. On an unknown date, Red blood cell count: high (High) high. On an unknown date, Weight: lost 8 pounds (abnormal) Lost 8 pounds.         No concomitant medication was reported. In the night after taking vaccine, the patient had fever, vomiting, nausea and diarrhea. The patient did not take Rubraca on 26-Jan and 27-Jan as she was feelin unwell. The nausea  and vomiting continued till 28-Jan-2022 The patient went to emergency room and told she was dehydrated and also lost 8 pounds. Then treated with fluids, felt better and went home. She still not feeling good and gained 2 pound and sticking to BRAT diet. The reporter did not access causal relationship between Rubraca and the events. COMPANY COMMENT: This is an Spontaneous case concerning an 69-years-old female patient with  medical history of Co-suspect product included non-company product RUCAPARIB CAMSYLATE (RUBRACA) for Malignant neoplasm of ovary who experienced the unexpected  (seriousness criterion  IME) events of WEIGHT DECREASED, MALAISE, DIARRHOEA, RETICULOCYTE COUNT INCREASED, DECREASED APPETITE, DYSPNOEA, ASTHENIA, DEHYDRATION, HAEMOGLOBIN DECREASED, NAUSEA, PYREXIA, VOMITING, CONFUSIONAL STATE, GAIT DISTURBANCE and HYPOPHAGIA unknown days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an Spontaneous case concerning an 69-years-old female patient with  medical history of Co-suspect product included non-company product RUCAPARIB CAMSYLATE (RUBRACA) for Malignant neoplasm of ovary who experienced the unexpected  (seriousness criterion  IME) events of WEIGHT DECREASED, MALAISE, DIARRHOEA, RETICULOCYTE COUNT INCREASED, DECREASED APPETITE, DYSPNOEA, ASTHENIA, DEHYDRATION, HAEMOGLOBIN DECREASED, NAUSEA, PYREXIA, VOMITING, CONFUSIONAL STATE, GAIT DISTURBANCE and HYPOPHAGIA unknown days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.