Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Femur fracture, Hot flush, Lower limb fracture
Clinical narrative: Itchy; hot flashes; fatigue; foggy brain; fractured femur; Fractured Leg; nausea; forgetting;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020US030834.  A 74-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; enzalutamide (ENZALUTAMIDE); enzalutamide (ENZALUTAMIDE), (Lot number: FD8716, Expiration Date: 31Aug2024) at 160 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset 13Jan2020, outcome "unknown", described as "forgetting"; NAUSEA (non-serious) with onset 13Jan2020, outcome "unknown"; LOWER LIMB FRACTURE (medically significant) with onset 03Sep2020, outcome "unknown", described as "Fractured Leg"; FEMUR FRACTURE (medically significant) with onset Oct2020, outcome "unknown", described as "fractured femur"; PRURITUS (non-serious), outcome "unknown", described as "Itchy"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; FATIGUE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "foggy brain". The action taken for enzalutamide and enzalutamide was unknown. The clinical course was reported as follows: on 03Sep2020, the patient had fractured leg. On an unspecified date in Oct2020, the patient had fractured femur and on an unspecified date patient experienced itchy, fatigue in the afternoon, foggy brain and hot flashes. On 13Jan2020, the patient has had side effects of nausea and forgetting. On 31Aug2022 the patient had experienced hot flashes. The patient also experienced fatigue and hot flashes at the time he got covid booster. Action taken with enzalutamide (capsule and tablet) treatment in response to the events was unknown. Action taken with covid-19 vaccine In response to events fatigue in the afternoon and hot flashes was unknown and in response to other events was not applicable. No additional information available. The patient assessed the following events with respect to enzalutamide (capsule and tablet) and covid-19 vaccine: fractured leg, fractured femur, itchy, fatigue in the afternoon, foggy brain, hot flashes, nausea, forgetting (seriousness: Not Reported; causality: Not Assessed).  The reporter's assessment of the causal relationship of "fractured leg", "fractured femur", "itchy", "hot flashes", "nausea", "forgetting", "fatigue" and "foggy brain" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Sender Comment (Astellas): Product: Enzalulamide capsule and tablet Leg fracture and Femur fracture were assessed as Serious due to Medically Significant. Itchy, Fatigue, Foggy feeling in head, Hot flashes, Nausea and Forgetfulness were assessed as Non-Serious. Medically Significant is based on nature of the events. Non-Serious is based on events not meeting ICH seriousness criteria. Astellas assessed Itchy, Fatigue, Foggy feeling in head, Hot flashes, Nausea and Forgetfulness as Related, based on plausible temporal relationship and known drug safety profile for Itchy, Fatigue, Hot flashes, Nausea and Forgetfulness. Elderly age could be the confounder for all events except Itchy and Hot flashes. Covid booster could be confounder for recent episode of fatigue and hot flashes. The other events Leg fracture and Femur fracture were assessed as Not Related, based on limited available information about the circumstances leading to the fractures. Elderly age could be the risk factor.; Sender's Comments: Based on the limited information provided in this case and considering a plausible drug-event temporal association, there is a NOT a reasonable possibility that the events (Leg fracture and Femur fracture) are related to BNT162b2 (COMIRNATY) administration. Elderly age may be a risk factor. However, the other reported events (Itchy, Fatigue, Foggy feeling in head, Hot flashes, Nausea and Forgetfulness) are considered related based on the nature and the known safety profile of the suspect product. There is limited information provided in this report. Case will be reassessed when additional information becomes available.