Sex: F
Vaccine: COVID19-2
Symptoms: Platelet count decreased
Clinical narrative: Other blood counts and Liver enzymes went really high; Other blood counts and Liver enzymes went really high; Platelets dropped/ Mild low platelet count; This spontaneous case was reported by a patient and describes the occurrence of FULL BLOOD COUNT INCREASED (Other blood counts and Liver enzymes went really high), HEPATIC ENZYME INCREASED (Other blood counts and Liver enzymes went really high) and PLATELET COUNT DECREASED (Platelets dropped/ Mild low platelet count) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRAPARIB TOSYLATE MONOHYDRATE (ZEJULA) capsule for Ovarian cancer.    Concurrent medical conditions included Essential hypertension, Ovarian cancer (CDK12 mutation of tumor), Drug allergy (Codeine allergy), Palpitation and Blood pressure high. Concomitant products included METOPROLOL SUCCINATE for Blood pressure high and Palpitation, AZELASTINE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLALANINE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE;PHENYLALANINE]), MELATONIN, MACROGOL 3350 (MIRALAX), ONDANSETRON, PROCHLORPERAZINE MALEATE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In December 2021, the patient started NIRAPARIB TOSYLATE MONOHYDRATE (ZEJULA) (Oral) 200 milligram. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FULL BLOOD COUNT INCREASED (Other blood counts and Liver enzymes went really high), HEPATIC ENZYME INCREASED (Other blood counts and Liver enzymes went really high) and PLATELET COUNT DECREASED (Platelets dropped/ Mild low platelet count). At the time of the report, FULL BLOOD COUNT INCREASED (Other blood counts and Liver enzymes went really high), HEPATIC ENZYME INCREASED (Other blood counts and Liver enzymes went really high) and PLATELET COUNT DECREASED (Platelets dropped/ Mild low platelet count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: really high. On an unknown date, Hepatic enzyme: really high. On an unknown date, Platelet count: Platelets dropped/ Mild low platelet.         Concomitant medication also included Stool softener.  No treatment medication was reported.  As per the patient Zejula gave the mild low platelet count.  Company Comment: This is a Spontaneous case reported by a patient, concerning a female patient of unknown age, with relevant concomitant medications of niraparib tosylate monohydrate (for ovarian cancer), metoprolol succinate (for blood pressure high and palpitations) and diphenhydramine hydrochloride, who experienced the unexpected and non-serious AESI of Platelet count decreased, which occurred after mRNA-1273.222 vaccine, administered as a booster dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Patient reported her platelets dropped, as well as other blood counts and liver enzymes went really high. She informed that niraparib tosylate monohydrate gives her mild low platelet counts (the product remains co-suspect). At the time of the report, outcome of the event was unknown. Concomitant medication remains a confounder for the case. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.