Age: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Platelet count decreased, Product use complaint, Unevaluable event, Vomiting
Clinical narrative: NOT SLEEPING; WEAK; LOW PLATELETS; ACHY LEGS with VENCLEXTA; Vomiting; PILLS WAS HARD TO SWALLOW; BOUND UP SO BAD; SEVEN TIMES WHEN FIRST STARTED TO URINATE AT NIGHT; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (NOT SLEEPING), NOCTURIA (SEVEN TIMES WHEN FIRST STARTED TO URINATE AT NIGHT), ASTHENIA (WEAK), PLATELET COUNT DECREASED (LOW PLATELETS) and UNEVALUABLE EVENT (BOUND UP SO BAD) in an 82-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) film-coated tablet for Acute myeloblastic leukemia.    Concurrent medical conditions included Acute myeloblastic leukemia.   On 09-May-2022, the patient started VENETOCLAX (VENCLEXTA) (Oral) 400 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In May 2022, the patient experienced INSOMNIA (NOT SLEEPING), ASTHENIA (WEAK), PLATELET COUNT DECREASED (LOW PLATELETS), PAIN IN EXTREMITY (ACHY LEGS with VENCLEXTA), VOMITING (Vomiting) and PRODUCT USE COMPLAINT (PILLS WAS HARD TO SWALLOW). In 2022, the patient experienced NOCTURIA (SEVEN TIMES WHEN FIRST STARTED TO URINATE AT NIGHT) and UNEVALUABLE EVENT (BOUND UP SO BAD). At the time of the report, INSOMNIA (NOT SLEEPING), NOCTURIA (SEVEN TIMES WHEN FIRST STARTED TO URINATE AT NIGHT), ASTHENIA (WEAK), UNEVALUABLE EVENT (BOUND UP SO BAD), PAIN IN EXTREMITY (ACHY LEGS with VENCLEXTA), VOMITING (Vomiting) and PRODUCT USE COMPLAINT (PILLS WAS HARD TO SWALLOW) outcome was unknown and PLATELET COUNT DECREASED (LOW PLATELETS) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Platelet count: Low.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  The patient had vomited after getting two of VENCLEXTA shots and had low platelet but felt really good as platelets keep rising as of 31-Aug-2022.  The reporter's causality for the events of PILLS WAS HARD TO SWALLOW, NOT SLEEPING,SEVEN TIMES WHEN FIRST STARTED TO URINATE AT NIGHT, VOMITING, WEAK and ACHY LEGS were not provided for Venclexta. Company comment- This is a spontaneous case concerning an 82-year-old male patient treated with venetoclax, reported as co-suspect, for acute myeloblastic leukemia who experienced the AESI platelet count decreased. A dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. Treatment with venetoclax remains as a confounder.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 82-year-old male patient treated with venetoclax, reported as co-suspect, for acute myeloblastic leukemia who experienced the AESI platelet count decreased. A dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. Treatment with venetoclax remains as a confounder.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.