Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Confusional state, Diarrhoea, Nausea
Clinical narrative: lowplatelet counts; BP low; Out of sorts or confused; Occasional bouts of diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Out of sorts or confused), PLATELET COUNT DECREASED (low platelet counts) and BLOOD PRESSURE DECREASED (BP low) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Renal neoplasm. Concurrent medical conditions included Neoplasm (MAL NEOPLASM OF LT KIDNEY). Concomitant products included PREDNISONE, DOCUSATE SODIUM (STOOL SOFTENER), PROCHLORPERAZINE EDISYLATE, LOPERAMIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ONDANSETRON, TRAZODONE, LISINOPRIL, VENLAFAXINE, ACETYLSALICYLIC ACID (ASPIRINE), LEVOTHYROXINE and PANTOPRAZOLE SODIUM for an unknown indication. On 15-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 14 milligram once a day. On 16-Sep-2021, the patient experienced CONFUSIONAL STATE (Out of sorts or confused) (seriousness criterion hospitalization). On an unknown date, the patient experienced PLATELET COUNT DECREASED (lowplatelet counts) (seriousness criterion hospitalization), BLOOD PRESSURE DECREASED (BP low) (seriousness criterion hospitalization), DIARRHOEA (Occasional bouts of diarrhea) and NAUSEA (Nausea). At the time of the report, CONFUSIONAL STATE (Out of sorts or confused), BLOOD PRESSURE DECREASED (BP low), DIARRHOEA (Occasional bouts of diarrhea) and NAUSEA (Nausea) outcome was unknown and PLATELET COUNT DECREASED (low platelet counts) was resolving. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Blood pressure low. On an unknown date, Platelet count: low (Low) Platelets count low. On an unknown date, Scan: abnormal (abnormal) tumor shrinkage. No treatment information was provided. Company Comment: This case concerns a male of unknown age with history of malignant neoplasm of the left kidney who experienced serious unexpected event of confusion state, decreased platelets and blood pressure decreased one day after the third dose of the Moderna Covid 19 vaccine. Medical history of malignant neoplasm of the left kidney and concomitant medication Levlima are confounders. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report. This case was linked to MOD-2021-331479 (Patient Link). Reporter did not allow further contact; Sender's Comments: This case concerns a male of unknown age with history of malignant neoplasm of the left kidney who experienced serious unexpected event of confusion state, decreased platelets and blood pressure decreased one day after the third dose of the Moderna Covid 19 vaccine. Medical history of malignant neoplasm of the left kidney and concomitant medication Levlima are confounders. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.