Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Headache, Hot flush
Clinical narrative: Insomnia / Trouble sleeping; Hot sweats/Hot flashes; slightly elevated BP/ BP was 140s over 90; Fatigue / felt more exhausted / Tired most of the time; Minor headaches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia / Trouble sleeping), HOT FLUSH (Hot sweats/Hot flashes), BLOOD PRESSURE INCREASED (slightly elevated BP/ BP was 140s over 90), FATIGUE (Fatigue / felt more exhausted / Tired most of the time) and HEADACHE (Minor headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE (XTANDI) for Malignant neoplasm of prostate.    Concurrent medical conditions included Malignant neoplasm of prostate and Neoplasm malignant. Concomitant products included ATORVASTATIN, MELOXICAM, METFORMIN HCL, TAMSULOSIN, FINASTERIDE, LORATADINE (CLARITIN [LORATADINE]), CALCIUM, UBIDECARENONE (CO Q 10 [UBIDECARENONE]), GLIPIZIDE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 09-Oct-2021, the patient started ENZALUTAMIDE (XTANDI) (Oral) 160 milligram once a day. On 09-Oct-2021, ENZALUTAMIDE (XTANDI) (Oral) dosage was changed to 160 milligram once a day. On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia / Trouble sleeping), HOT FLUSH (Hot sweats/Hot flashes), BLOOD PRESSURE INCREASED (slightly elevated BP/ BP was 140s over 90), FATIGUE (Fatigue / felt more exhausted / Tired most of the time) and HEADACHE (Minor headaches). At the time of the report, INSOMNIA (Insomnia / Trouble sleeping), HOT FLUSH (Hot sweats/Hot flashes), BLOOD PRESSURE INCREASED (slightly elevated BP/ BP was 140s over 90), FATIGUE (Fatigue / felt more exhausted / Tired most of the time) and HEADACHE (Minor headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: weight loss (Low) During the beginning of treatment in Oct-2021, the patient had lost some weight.  However, he had gained that weight back.. On an unknown date, Blood pressure measurement: 140/90 slightly elevated BP: 140s/90.         The patient received Moderna booster dose and since then he was feeling more exhausted and fatigued. The patient would be having a cataract surgery soon. The intensity was reported as mild.  Company comment: This is a spontaneous case concerning a 75-year-old, male patient with relevant concurrent medical condition of prostate cancer and with concomitant medication of Enzalutamide (Xtandi) for the treatment of prostate cancer, who experienced the unexpected non-serious events of hot flush, blood pressure increased and insomnia and the expected non-serious events of fatigue aggravated and headache. The event fatigue aggravated exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration while the events hot flush, blood pressure increased, headache and insomnia exact occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events were unknown. The concurrent medical condition of prostate cancer and the concomitant medication of Enzalutamide (Xtandi) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Follow-up received contains No New Information. On 25-Feb-2022: Significant Follow-up received: Patient Initials, DOB, gender and age updated. Patient past medical History updated. Laboratory data updated. Suspect Drug Indication, start date updated. Concomitant drugs added. Event outcomes updated. On 25-Feb-2022: Follow-up received contains No New Information.; Sender's Comments: This is a spontaneous case concerning a 75-year-old, male patient with relevant concurrent medical condition of prostate cancer and with concomitant medication of Enzalutamide (Xtandi) for the treatment of prostate cancer, who experienced the unexpected non-serious events of hot flush, blood pressure increased and insomnia and the expected non-serious events of fatigue aggravated and headache. The event fatigue aggravated exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration while the events hot flush, blood pressure increased, headache and insomnia exact occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events were unknown. The concurrent medical condition of prostate cancer and the concomitant medication of Enzalutamide (Xtandi) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.